FDA FOIA Log FY2018

Control# Recd Date Requester
2017-10000 11/27/2017 Research Delta Advisors

2017-10001 11/27/2017 UNIGEN
2017-10002 11/28/2017 Alec White

2017-10003 11/28/2017 GEORGE WASHINGTON UNIVERSITY
2017-10004 11/28/2017 Leslie W. O'Leary
2017-10005 11/28/2017 Aleor Dermaceuticals Limited
2017-10006 11/28/2017 Keller and Heckman LLP
2017-10007 11/28/2017 TRIBO Hartstoff GmbH
2017-10008 11/28/2017 Clarivate Analytics
2017-10009 11/28/2017 Ultralite Enterprises Inc.

2017-10010 11/28/2017 The Indian Express
2017-10011 11/28/2017 First Coast News
2017-10012 11/28/2017 Amin Talati Upadhye, LLP

2017-10013 11/28/2017 Sterigenics US LLC
2017-10014 11/28/2017 IIFL Capital

2017-10015 11/28/2017 York Law Corporation
2017-10016 11/28/2017 Pennock Law Firm

2017-10017 11/28/2017 Salamandra, LLC
2017-10018 11/28/2017 Pennock Law Firm
2017-10019 11/28/2017 Neuronetics, Inc.
2017-10020 11/28/2017 Kevin A Phelan LLC
2017-10021 11/28/2017 WHARTON SCHOOL, UNIVERSITY OF PENNSYLVANIA
2017-10022 11/28/2017 PHOTOCURE ASA

2017-10025 11/28/2017 Crossover Capital Partners

2017-10026 11/28/2017 IntroMedic Co., Ltd.
2017-10027 11/28/2017 Sean White
2017-10028 11/28/2017 Human Predictions LLC

2017-10029 11/28/2017 Novel Laboratories, Inc.
2017-10030 11/28/2017 Citigroup Global Markets Pvt. Ltd. India
2017-10031 11/28/2017 Doe J

2017-10033 11/29/2017 CorAlert Ltd.
2017-10034 11/29/2017 Cuvee Coffee
2017-10035 11/29/2017 FDAZILLA
2017-10036 11/29/2017 Partner Fund Management

2017-10038 11/29/2017 Doe J
2017-10039 11/29/2017 Paul Rumage, Attorney at Law

2017-10040 11/29/2017 FOIA GROUP INC
2017-10041 11/29/2017 Yana Pruss
2017-10042 11/29/2017 Paul Rumage, Attorney at Law
2017-10043 11/29/2017 JE Differential Trading LLC

2017-10044 11/29/2017 Willem Haspeslagh
2017-10045 11/29/2017 GlucoSet AS
2017-10046 11/29/2017 Popular Science
2017-10047 11/29/2017 Wilson Sonsini Goodrich & Rosati, P.C.
2017-10048 11/29/2017 KEYS 22458-017, CLAY
2017-10049 11/29/2017 JH BARR & ASSOCIATES LLC
2017-10053 11/29/2017 WASHINGTON INFORMATION SOURCE
2017-10056 11/29/2017 DOMINION GROUP INC
2017-10059 11/29/2017 WOLTERS KLUWER LAW & BUSINESS
2017-10062 11/29/2017 Center for Regulator Services, Inc
2017-10065 11/29/2017 FOI Services, Inc.
2017-10066 11/29/2017 FOI Services, Inc.
2017-10067 11/29/2017 FOI Services, Inc.
2017-10068 11/29/2017 FDA NEWS
2017-10069 11/29/2017 FDA NEWS
2017-10070 11/29/2017 FDA NEWS
2017-10075 11/30/2017 FOI Services, Inc.
2017-10076 11/30/2017 FOI Services, Inc.
2017-10077 11/30/2017 FOI Services, Inc.
2017-10078 11/30/2017 FOI Services, Inc.
2017-10079 11/30/2017 FOI Services, Inc.
2017-10080 11/30/2017 FDA REVIEW/FDA WEBVIEW
2017-10091 11/30/2017 FDA NEWS
2017-10093 12/01/2017 lynn, Catherine
2017-10094 12/01/2017 Samy Hamdouche

2017-10095 12/01/2017 Hyman Phelps & McNamara
2017-10096 12/01/2017 GENENTECH INC
2017-10097 12/01/2017 Leading Pharma, LLC
2017-10098 12/01/2017 barbara kurys
2017-10099 12/01/2017 MICRO LABS LIMITED
2017-10100 12/01/2017 Morgan Lesko
2017-10101 12/01/2017 Encube Ethicals
2017-10102 12/01/2017 Ross Feller Casey, LLP

2017-10103 12/01/2017 WFTS-TV
2017-10104 12/01/2017 Dr Ajay Phadke
2017-10105 12/01/2017 ConceptoMed AS
2017-10106 12/01/2017 AMERICAN HERBAL PRODUCTS ASSOCIATION
2017-10107 12/01/2017 Nirmal Bang Institutional Equities
2017-10109 12/01/2017 Ross Feller Casey, LLP

2017-10110 12/01/2017 FOI Services, Inc.
2017-10111 12/01/2017 Michclone Associates Inc
2017-10112 12/01/2017 Cognitive Research Corporation

2017-10113 12/01/2017 University of Missouri School of Law Library
2017-10114 12/01/2017 Strides Shasun Limited
2017-10115 12/01/2017 Cheng Yi Optical (Xiamen) Co., LTD
2017-10116 12/01/2017 Vena Medical Inc.
2017-10118 12/01/2017 Pink Sheet/Scrip, part of Informa Plc
2017-10119 12/01/2017 Citigroup Global Markets Pvt. Ltd. India
2017-10120 12/01/2017 FOI Services, Inc.
2017-10121 12/01/2017 FOI Services, Inc.
2017-10122 12/01/2017 FOI Services, Inc.
2017-10123 12/01/2017 Susan Thixton/Association for Truth in Pet Food

2017-10124 12/01/2017 AMAG Pharmaceuticals
2017-10125 12/01/2017 Quinn Eastman
2017-10126 12/01/2017 IPD ANALYTICS LLC
2017-10127 12/01/2017 AXIS Clinicals LLC USA

2017-10128 12/01/2017 FDAAWARE
2017-10129 12/01/2017 Repro-Med Systems Inc.

2017-10131 12/01/2017 AMERICA RISING ADVANCED RESEARCH
2017-10132 12/01/2017 FOI Services, Inc.
2017-10133 12/01/2017 FOI Services, Inc.
2017-10134 12/01/2017 FOI Services, Inc.
2017-10135 12/01/2017 Micro-Tech (Nanjing) Co., Ltd.
2017-10136 12/01/2017 FOI Services, Inc.
2017-10137 12/01/2017 FOIA GROUP INC
2017-10138 12/01/2017 FOIA GROUP INC
2017-10139 12/01/2017 FOIA GROUP INC
2017-10140 12/01/2017 FOIA GROUP INC
2017-10141 12/01/2017 BEAN KINNEY & KORMAN PC
2017-10142 12/01/2017 FOIA GROUP INC
2017-10143 12/01/2017 FOIA GROUP INC
2017-10148 12/01/2017 MUCKROCK NEWS

2017-10149 12/01/2017 Akerman LLP
2017-10150 12/01/2017 DUNN SHEEHAN LLP

2017-10151 12/01/2017 LAGANA 346-048, JOEEPH
2017-10152 12/01/2017 CHAMP #168896, SEAN PHILLIP
2017-10153 12/01/2017 FAIRFIELD CONSULTING LLC
2017-10154 12/01/2017 O'CONNOR, NYKA

2017-10155 12/04/2017 FDAAWARE
2017-10156 12/04/2017 FDAAWARE
2017-10157 12/04/2017 Solaris Pharma Corporation
2017-10158 12/04/2017 Ichorion Ventures
2017-10159 12/04/2017 Cecacor Laboratories Inc
2017-10160 12/04/2017 Analysis Group, Inc.
2017-10161 12/04/2017 Arkema Inc.
2017-10162 12/04/2017 Joshua Sharlin
2017-10164 12/04/2017 Patrick Crutcher
2017-10165 12/04/2017 Salim-Beasley LLC
2017-10167 12/04/2017 barbara kurys
2017-10168 12/04/2017 Forus Health Pvt. Ltd.
2017-10169 12/04/2017 Piramal Enterprises Limited
2017-10170 12/04/2017 OHIO ENVIRONMENTAL COUNCIL
2017-10171 12/04/2017 Dr. Reddy's Laboratories Inc.
2017-10173 12/04/2017 Kevin A Phelan LLC
2017-10174 12/04/2017 HAYNES AND BOONE, LLP
2017-10175 12/04/2017 Ralph H Johnson VA Medical Center

2017-10176 12/04/2017 NOVO NORDISK INC
2017-10177 12/04/2017 FOIA GROUP INC
2017-10178 12/04/2017 U.S. Right to Know

2017-10179 12/04/2017 Morgan Stanley
2017-10182 12/04/2017 Prateek Goyal
2017-10183 12/04/2017 The Rosen Law Firm, P.A.

2017-10184 12/04/2017 Nabila Justianto
2017-10185 12/04/2017 FOI Services, Inc.
2017-10186 12/04/2017 GLAWE, JUSTIN
2017-10187 12/04/2017 TORRENT PHARMA INC

2017-10188 12/04/2017 IOVATE HEALTH SCIENCES INTERNATIONAL INC
2017-10189 12/04/2017 Bienert, Miller & Katzman, PLC

2017-10190 12/04/2017 COMPLIANCE SYSTEMS INTERNATIONAL LLC
2017-10191 12/04/2017 CONSUMER HEALTHCARE PRODUCTS ASSOCIATION
2017-10193 12/04/2017 PARAGON 28 INC

2017-10194 12/04/2017 VISOCCHI, ALICE
2017-10195 12/04/2017 HUI, ADA

2017-10196 12/04/2017 Caplin Point Laboratories Limited
2017-10197 12/04/2017 STEVENSON, SARAH
2017-10198 12/04/2017 STAT

2017-10199 12/04/2017 Datavant
2017-10200 12/04/2017 Datavant
2017-10201 12/04/2017 Datavant
2017-10202 12/04/2017 Datavant
2017-10203 12/04/2017 Datavant
2017-10204 12/04/2017 Datavant
2017-10205 12/04/2017 Datavant
2017-10206 12/04/2017 ET Now

2017-10208 12/04/2017 Datavant
2017-10209 12/04/2017 Datavant
2017-10210 12/04/2017 Labaton Sucharow LLP
2017-10211 12/04/2017 Celgene Corporation

Amrita Centre For Nanosciences & Molecular
2017-10213 12/04/2017 Medicine
2017-10214 12/04/2017 Datavant
2017-10215 12/04/2017 Jacob Webster
2017-10216 12/04/2017 Hyman, Phelps, & McNamara
2017-10217 12/04/2017 ASSOCIATED PRESS
2017-10218 12/04/2017 L'OREAL

2017-10219 12/04/2017 L'OREAL
2017-10220 12/04/2017 FOI Services, Inc.

2017-10221 12/04/2017 Bill Fuller @Fuller, Taylor & Holton
2017-10222 12/04/2017 FOI Services, Inc.
2017-10223 12/04/2017 FOI Services, Inc.
2017-10224 12/04/2017 Rumrell, McLeod & Brock, PA
2017-10225 12/04/2017 Christopher Fallon
2017-10226 12/05/2017 Robert M Eddy

2017-10227 12/05/2017 FOI Services, Inc.
2017-10228 12/05/2017 Granules Pharmaceuticals Inc
2017-10229 12/05/2017 Datavant
2017-10230 12/05/2017 Lupin Pharmaceuticals, Inc.
2017-10231 12/05/2017 Nicoletta Tulino

2017-10232 12/05/2017 Datavant
2017-10233 12/05/2017 FOI Services, Inc.
2017-10234 12/05/2017 Debtwire-Acuris

2017-10235 12/05/2017 Doe J
2017-10236 12/05/2017 Center for Regulatory Services Inc.
2017-10237 12/05/2017 CEUTICAL LABS

2017-10238 12/05/2017 FOI Services, Inc.
2017-10239 12/05/2017 Rawls Law Group, P.C.
2017-10240 12/05/2017 Nexgen Pharma, Inc.
2017-10241 12/05/2017 Louisiana Tech University
2017-10242 12/05/2017 STAT
2017-10243 12/05/2017 POMERANTZ LLP

2017-10245 12/05/2017 BAKER & HOSTETLER, LLP

2017-10246 12/05/2017 MUCKROCK NEWS
2017-10247 12/05/2017 Choate, Hall & Stewart LLP
2017-10248 12/05/2017 Doe J
2017-10249 12/05/2017 BRIGHAM AND WOMEN'S HOSPITAL


2017-10252 12/05/2017 Doe J
2017-10253 12/05/2017 Datavant
2017-10254 12/05/2017 Britton, Alma
2017-10255 12/05/2017 FOI Services, Inc.
2017-10256 12/05/2017 FOI Services, Inc.
2017-10257 12/05/2017 SPAULDING, PETER
2017-10258 12/05/2017 Northgate Technologies, Inc.

2017-10259 12/05/2017 Cogencis Information Services
2017-10260 12/05/2017 LONDON FISCHER LLP
2017-10261 12/05/2017 Foley Baron Metzger & Juip, PLLC

2017-10262 12/05/2017 ABIGO Medical AB
2017-10263 12/05/2017 Kirkland and Ellis LLP
2017-10264 12/05/2017 Susan Dudish-Poulsen
2017-10265 12/05/2017 SOROS FUND MANAGEMENT

2017-10266 12/05/2017 COVINGTON & BURLING LLP
2017-10267 12/05/2017 The Weinberg Group
2017-10268 12/05/2017 Xpro Associates LLC

2017-10269 12/05/2017 FORBES MAGAZINE
2017-10270 12/05/2017 Doe J
2017-10271 12/06/2017 Virginia Dare Extract Company Inc

2017-10272 12/06/2017 Harvard
2017-10273 12/06/2017 Harvard
2017-10274 12/06/2017 Entreprises Importfab Inc.

2017-10276 12/06/2017 Galt Medical Corp
2017-10277 12/06/2017 FDAZILLA
2017-10279 12/06/2017 FDAZILLA
2017-10280 12/06/2017 FDAZILLA

2017-10283 12/06/2017 Akorn Inc.
2017-10284 12/06/2017 Lehrman Beverage Law, PLLC
2017-10285 12/06/2017 Motilal oSwal Securities Limited
2017-10286 12/06/2017 Vermont Public Radio

2017-10287 12/06/2017 HARVARD MEDICAL SCHOOL
2017-10288 12/06/2017 Prateek Goyal

Instrument Technology Research Center (ITRC) ,
2017-10289 12/06/2017 National Applied Research Laboratories
2017-10290 12/06/2017 CQ Roll Call

2017-10291 12/06/2017 Misonix,inc
2017-10293 12/06/2017 Folger Hill Asset Management

2017-10294 12/06/2017 Merck Animla Health
2017-10295 12/06/2017 Mirza, Tahseen
2017-10296 12/06/2017 Atlantic Pharmaceuticals, Inc.

2017-10297 12/06/2017 Zachary Cole
2017-10298 12/06/2017 REGENERON PHARMACEUTICALS INC
2017-10300 12/06/2017 Conventus Biomedical Solutions, Inc.
2017-10301 12/06/2017 PETA
2017-10302 12/06/2017 Cardno ChemRisk

2017-10304 12/06/2017 FDAZILLA
2017-10305 12/06/2017 CQ Roll Call
2017-10306 12/06/2017 Nomura Securities
2017-10307 12/06/2017 FDAZILLA
2017-10308 12/06/2017 FDAZILLA
2017-10309 12/06/2017 ET Now
2017-10310 12/06/2017 Bloomberg News
2017-10311 12/06/2017 UBS

2017-10312 12/06/2017 Charles Jacquin et CIE,Inc.
2017-10313 12/06/2017 The Seattle Times
2017-10314 12/06/2017 Wagner Solutions, LLC

2017-10315 12/06/2017 FOI Services, Inc.
2017-10316 12/06/2017 Aerie Pharmaceuticals, Inc.
2017-10317 12/06/2017 BLOOMBERG NEWS

2017-10318 12/06/2017 FOI Services, Inc.
2017-10319 12/06/2017 FOI Services, Inc.
2017-10320 12/06/2017 DEMOCRATIC NATIONAL COMMITTEE

2017-10327 12/07/2017 FDA NEWS
2017-10328 12/07/2017 FDA NEWS
2017-10335 12/07/2017 FOI Services, Inc.
2017-10336 12/07/2017 FOI Services, Inc.
2017-10337 12/07/2017 FOI Services, Inc.
2017-10338 12/07/2017 FOI Services, Inc.
2017-10343 12/07/2017 Jake Todd

2017-10344 12/07/2017 Registrar Corp
2017-10345 12/07/2017 goodrich associates
2017-10346 12/07/2017 NBC NEWS

2017-10348 12/07/2017 Registrar Corp
2017-10349 12/07/2017 Steven Scott

2017-10350 12/07/2017 Registrar Corp
National Institute of Securities Markets, Navi
2017-10351 12/07/2017 Mumbai
2017-10352 12/07/2017 Globizz Corporation
2017-10353 12/07/2017 Point Seven Two Asset Management
2017-10354 12/07/2017 NATIONAL MILK PRODUCERS FEDERATION
2017-10355 12/07/2017 Bloomberg Quint
2017-10356 12/07/2017 ICICI Securities
2017-10357 12/07/2017 MORRISON & FOERSTER LLP

2017-10358 12/07/2017 CBR INTERNATIONAL CORP
2017-10359 12/07/2017 FOI Services, Inc.

2017-10360 12/07/2017 Brennan Group
2017-10361 12/07/2017 Sun Nuclear Corporation
2017-10362 12/07/2017 Somatics LLC
2017-10363 12/07/2017 MDSG
2017-10364 12/07/2017 Juliana Keeping
2017-10366 12/07/2017 Gamma Surgery
2017-10368 12/07/2017 ULTRADENT PRODUCTS INC
2017-10370 12/07/2017 ET Now
2017-10371 12/07/2017 Axis Capital
2017-10372 12/07/2017 Jeffrey Springer
2017-10373 12/07/2017 HEALTHCOR MANAGEMENT LP

2017-10375 12/07/2017 Zoetis Inc.
2017-10376 12/07/2017 ANAPOLWEISS
2017-10377 12/07/2017 ANAPOLWEISS
2017-10378 12/07/2017 ANAPOLWEISS
2017-10379 12/07/2017 ANAPOLWEISS

2017-10381 12/07/2017 VIDA DIAGNOSTICS
2017-10382 12/07/2017 Doe J
2017-10383 12/07/2017 HeartStitch Inc.

2017-10384 12/07/2017 LUPRON VICTIMS HUB
2017-10385 12/07/2017 FOLEY HOAG LLP
2017-10386 12/07/2017 PRICE, KIMBER

2017-10387 12/07/2017 WILSON SONSINI ET AL
2017-10388 12/07/2017 DUNN SHEEHAN LLP

2017-10389 12/07/2017 WILSON CAIN ET AL
2017-10390 12/07/2017 SCHULTE, ROTH & ZABEL LLP
2017-10391 12/07/2017 TATE-EL-BEY-TEY-WASH, MARCUS
2017-10392 12/07/2017 MUCKROCK
2017-10393 12/07/2017 Lin Ryther

2017-10394 12/08/2017 UNIVERSITY COLLEGE DUBLIN
Southern Institute for Medical & Legal Affairs
2017-10395 12/08/2017 LLC
2017-10396 12/08/2017 Brennan Group
2017-10397 12/08/2017 FOI Services, Inc.

2017-10398 12/08/2017 COGENCY GLOBAL,INC
2017-10399 12/08/2017 Jeff Brown
2017-10400 12/08/2017 Gala Therapeutics Inc.
2017-10401 12/08/2017 KLJ Associates
2017-10402 12/08/2017 KLJ Associates
2017-10403 12/08/2017 KLJ Associates

2017-10405 12/08/2017 KLJ Associates
2017-10406 12/08/2017 STAT
2017-10407 12/08/2017 CREDIT SUISSE
2017-10408 12/08/2017 HORIZON PHARMA INC
2017-10409 12/08/2017 Traditional Medicinals, Inc.

2017-10410 12/08/2017 Joshua Sharlin
2017-10411 12/08/2017 Shernoff Bidart Echeverria LLP
2017-10412 12/08/2017 Kurt Weber
2017-10413 12/08/2017 Kurt Weber

2017-10414 12/08/2017 Doe J
2017-10415 12/08/2017 GREENSTEIN, DAVID
2017-10416 12/08/2017 Altria Client Services
2017-10418 12/08/2017 Liggett Vector Brands Inc.

2017-10421 12/08/2017 FDA NEWS
2017-10422 12/08/2017 FOI Services, Inc.
2017-10428 12/08/2017 FOI Services, Inc.
2017-10430 12/08/2017 Prateek Goyal
2017-10431 12/08/2017 Morgan Stanley

2017-10433 12/11/2017 SMITH ROLFES & SKAVDAHL CO
2017-10434 12/11/2017 CONWAY HOMER PC
2017-10435 12/11/2017 DEERFIELD INSTITUTE
2017-10436 12/11/2017 TREU-INSTRUMENTE GMBH

2017-10437 12/11/2017 SMITH & NEPHEW
2017-10438 12/11/2017 FOIA GROUP INC
2017-10439 12/11/2017 STEPTOE & JOHNSON
2017-10440 12/11/2017 Julie Kieffer
2017-10441 12/11/2017 GRUPPO SINTESI

2017-10442 12/11/2017 Rawls Law Group PC
2017-10443 12/11/2017 FOIA GROUP INC
2017-10444 12/11/2017 Taylor English Duma LLP
2017-10446 12/11/2017 Teva
2017-10447 12/11/2017 SomaticsLLC

2017-10449 12/11/2017 Indivior Inc

2017-10451 12/11/2017 Teva Pharmaceuticals
2017-10452 12/11/2017 DEKA R&D
2017-10454 12/11/2017 Salamandra, LLC
2017-10455 12/11/2017 STERILMED
2017-10457 12/11/2017 FOX ROTHSCHILD LLP

2017-10459 12/11/2017 FOI Services, Inc.
2017-10460 12/11/2017 AuroMedics Pharma LLC ATTN: Regulatory Affairs

2017-10461 12/11/2017 Swedish Orphan Biovitrum AB (publ)
2017-10462 12/11/2017 Moab Partners
2017-10463 12/11/2017 FOI Services, Inc.

2017-10465 12/11/2017 AuroMedics Pharma LLC ATTN: Regulatory Affairs
2017-10466 12/11/2017 DEKA R&D
2017-10467 12/11/2017 FOI Services, Inc.
2017-10468 12/11/2017 Keith Hadley

2017-10469 12/12/2017 INDEPENDENCE LEGAL SUPPORT
2017-10470 12/12/2017 CHOICE MEDICAL COMMUNICATIONS

2017-10471 12/12/2017 Law Office of Daryl G. Hawkins LLC
2017-10472 12/12/2017 Humanscale
2017-10473 12/12/2017 Baker and Rannells, PA
2017-10474 12/12/2017 FDAZILLA

2017-10475 12/12/2017 FOI Services, Inc.
2017-10476 12/12/2017 BAXTER HEALTHCARE
2017-10477 12/12/2017 Green Chile Concepts, LLC

2017-10478 12/12/2017 B&H Consulting Services, Inc.
2017-10479 12/12/2017 FDAZILLA
2017-10480 12/12/2017 Yash Patel
2017-10481 12/12/2017 FDAZILLA

2017-10482 12/12/2017 LUPIN LTD
2017-10483 12/12/2017 Cox Media Group
2017-10484 12/12/2017 FOI Services, Inc.
2017-10485 12/12/2017 Doe J
2017-10486 12/12/2017 Robert Corty
2017-10487 12/12/2017 FOI Services, Inc.
2017-10489 12/12/2017 FOI Services, Inc.
2017-10490 12/12/2017 Doe J
2017-10491 12/12/2017 MORRISON MAHONEY LLP
2017-10492 12/12/2017 HOLLIS LAW FIRM PA

2017-10494 12/12/2017 KEYS 22458017, CLAY
2017-10495 12/12/2017 MCKELVIE, KAREN

2017-10496 12/12/2017 WINGERT GREBING BRUBAKER & JUSKIE LLP
2017-10498 12/13/2017 PELOTON THERAPEUTICS

2017-10499 12/13/2017 Carlos Rivera-Adrovet
2017-10500 12/13/2017 DRINKER BIDDLE & REATH LLP

2017-10501 12/13/2017 The Weston Firm
2017-10502 12/13/2017 Eberhardt, Heather
2017-10503 12/13/2017 Bark to Basics

2017-10504 12/13/2017 STEPTOE & JOHNSON
2017-10505 12/13/2017 Tim Peters
2017-10506 12/13/2017 THOMSON REUTERS (SCIENTIFIC) SAS
2017-10507 12/13/2017 Soroban Capital Partners

2017-10510 12/13/2017 Salamandra, LLC

2017-10511 12/13/2017 Valeant Pharmaceuticals (Bausch Lomb)
2017-10512 12/13/2017 PUTNAM ASSOCIATES INC

2017-10513 12/13/2017 FAVUS INSTITUTIONAL RESEARCH LLC
2017-10514 12/13/2017 Bisco, Inc.
2017-10515 12/13/2017 FOI Services, Inc.

2017-10516 12/13/2017 STEPTOE & JOHNSON
2017-10517 12/13/2017 Prince Agri Products, Inc.

2017-10518 12/13/2017 Bergeson & Campbell P.C.
2017-10519 12/13/2017 MERCANTUM US CORP
2017-10520 12/13/2017 WINGERT GREBING BRUBAKER & JUSKIE LLP
2017-10522 12/13/2017 HABERMAN 36897177, LAWRENCE

2017-10523 12/13/2017 ADAMS BO3660, ANTHONY
2017-10526 12/14/2017 OFW LAW
2017-10527 12/14/2017 Aquestive Therapeutics

2017-10528 12/14/2017 Kleinfeld, Kaplan and Becker LLP
2017-10530 12/14/2017 Sheffield Pharmaceuticals LLC
2017-10531 12/14/2017 FOI Services, Inc.

2017-10532 12/14/2017 Brenda Bacon
2017-10534 12/14/2017 MacroGenics, Inc.
2017-10535 12/14/2017 AidennLair Capital

2017-10536 12/14/2017 Garden Valley Corporation
2017-10537 12/14/2017 Sri Harsha Vemuri
2017-10538 12/14/2017 FOI Services, Inc.
2017-10539 12/14/2017 Geo-B Products Inc. DBA Estilo Uno

2017-10540 12/14/2017 Point Seventy Two
2017-10541 12/14/2017 COGENCY GLOBAL, INC
2017-10542 12/14/2017 REGENERON PHARMACEUTICALS INC
2017-10543 12/14/2017 FDA NEWS
2017-10544 12/14/2017 FOI Services, Inc.

2017-10545 12/14/2017 InControl Health
2017-10546 12/14/2017 FOI Services, Inc.

2017-10547 12/14/2017 Angie Domingues
2017-10549 12/14/2017 PATRICK BEARD ET AL
2017-10563 12/14/2017 ULTRA SEAL CORP
2017-10564 12/14/2017 VENA, NICHOLAS
2017-10565 12/14/2017 HEALTH FIRST FAMILY CARE CENTER
2017-10566 12/14/2017 Franklin D. Azar & Associates, P.C.
2017-10567 12/15/2017 DRINKER BIDDLE & REATH
2017-10568 12/15/2017 Nicholas & Tomasevic, LLP
2017-10570 12/15/2017 Amin Talati Upadhye LLP
2017-10571 12/15/2017 PD International, LLC

2017-10573 12/15/2017 Moab Partners

2017-10574 12/15/2017 Keller and Heckman LLC
2017-10575 12/15/2017 OraMetrix, Inc
2017-10576 12/15/2017 The Dominion Group
2017-10577 12/15/2017 BOSTON UNIVERSITY
2017-10578 12/15/2017 Coherus BioSciences Inc

2017-10579 12/15/2017 CURTIN UNIV SCHOOL OF PHARMACY
2017-10580 12/18/2017 BENJAMIN L ENGLAND & ASSOCIATES LLC
2017-10581 12/18/2017 PITZER SNODGRASS PC
2017-10582 12/18/2017 HUTTON & HUTTON LAW FIRM, L.L.C.
2017-10583 12/18/2017 AMCOR FLEXIBLES SINGEN GMBH

2017-10585 12/18/2017 LORI A CARR INC
2017-10586 12/18/2017 Texas Attorney General
2017-10587 12/18/2017 ROANOKE CLAIMS SERVICES

2017-10589 12/18/2017 FEDERAL DEFENDER SERVICES OF IDAHO
2017-10590 12/18/2017 Ashland LLC
2017-10591 12/18/2017 CASPER PHARMA LLC
2017-10592 12/18/2017 INDIVIDUAL
2017-10594 12/18/2017 Datavant
2017-10595 12/18/2017 Datavant
2017-10596 12/18/2017 Natures Way Brands LLC
2017-10597 12/18/2017 FOIA GROUP INC

2017-10598 12/18/2017 Incyte Corporation
2017-10599 12/18/2017 PROCTER & GAMBLE
2017-10600 12/18/2017 Areva Pharmaceuticals
2017-10601 12/18/2017 M.I.Tech Co., Ltd.
2017-10602 12/18/2017 Datavant
2017-10603 12/18/2017 Datavant
2017-10604 12/18/2017 EXPONENT, INC.
2017-10605 12/18/2017 Datavant
2017-10606 12/18/2017 Bilson, Jack
2017-10607 12/18/2017 Constantine, Edith

2017-10608 12/18/2017 Datavant
2017-10609 12/18/2017 Datavant
2017-10611 12/18/2017 Philip Spiller
2017-10612 12/18/2017 The Epstein Law Firm, P.A.
2017-10613 12/18/2017 Springfield News-Sun

2017-10616 12/18/2017 Orbicular Pharmaceutical’s Technologies Pvt Ltd.,
2017-10617 12/18/2017 WINSTEAD PC

2017-10620 12/18/2017 THOMSON REUTERS

2017-10625 12/18/2017 STAT News
2017-10626 12/18/2017 KING & SPALDING
2017-10627 12/18/2017 KING & SPALDING

2017-10628 12/18/2017 Allmed Group
2017-10629 12/18/2017 EAS Consulting Group, LLC


2017-10640 12/19/2017 THOMSON REUTERS

2017-10641 12/19/2017 Institute for Advanced Study in Toulouse
2017-10646 12/19/2017 Virbac Corporation
2017-10648 12/19/2017 Nicodemo Fiorentino

2017-10650 12/19/2017 Guangzhou nucien pharmaceutical Co., LTD.
2017-10651 12/19/2017 Sullivan IP Solutions

2017-10653 12/19/2017 Catachem, Inc.

2017-10656 12/19/2017 Rutgers Chemistry Department

2017-10659 12/19/2017 SIMON LAW FIRM PC

2017-10660 12/19/2017 JUDICIAL WATCH
SOCIETY OF QUALITY ASSURANCE (SQA) LEARNING

2017-10661 12/19/2017 FOUNDATION
SOCIETY OF QUALITY ASSURANCE (SQA) LEARNING
2017-10662 12/19/2017 FOUNDATION
2017-10663 12/19/2017 THOMAS GARVEY & GARVEY
2017-10664 12/19/2017 JUBILANT DRAXIMAGE INC
2017-10665 12/19/2017 PRUDENTIX LTD

2017-10666 12/19/2017 Doe J
2017-10667 12/20/2017 WOOD BURDITT GROUP
2017-10668 12/20/2017 Food & Water Watch

2017-10669 12/20/2017 CSL BEHRING
2017-10670 12/20/2017 CAM
2017-10671 12/20/2017 Safkhet Capital Management LLC
2017-10672 12/20/2017 Phyllis Entis

2017-10673 12/20/2017 Misonix,inc
2017-10674 12/20/2017 LIFE EXTENSION
2017-10675 12/20/2017 CROWELL & MORING
2017-10676 12/20/2017 Aesculap Implant Systems

2017-10677 12/20/2017 FDAZILLA
2017-10678 12/20/2017 Misonix, Inc
2017-10679 12/20/2017 MYOTRONICS-NOROMED, INC.
2017-10680 12/20/2017 Aesculap Implant Systems
2017-10681 12/20/2017 West-Ward Pharmaceuticals Corp.
2017-10682 12/20/2017 Sean Yuan
2017-10683 12/20/2017 Glen Capital Partners LLC

2017-10684 12/20/2017 Mengyao Fu
2017-10685 12/20/2017 Misonix,inc
2017-10686 12/20/2017 CROWELL & MORING

2017-10687 12/20/2017 Doe J
2017-10688 12/20/2017 GEORGE MASON UNIVERSITY
2017-10689 12/20/2017 OREGON HEALTH & SCIENCE UNIV
2017-10690 12/20/2017 DxTerity Diagnostics, Inc
2017-10694 12/20/2017 OREGON HEALTH & SCIENCE UNIV
2017-10695 12/20/2017 Dr Ajay Phadke
2017-10698 12/20/2017 NE Scientific, LLC
2017-10699 12/20/2017 Squaxin Island Tribe
2017-10700 12/20/2017 Jennifer Bellis, Esq

2017-10701 12/20/2017 Milla Pharmaceuticals
2017-10702 12/20/2017 LEXAMED
2017-10703 12/20/2017 LEXAMED
2017-10704 12/20/2017 ARCADIS
2017-10705 12/20/2017 INTRATHECAL COMPOUNDING SPECIALISTS LLC
2017-10706 12/20/2017 FLEMING, WES
2017-10707 12/20/2017 FOOD INDUSTRY COUNCIL LLC
2017-10708 12/20/2017 HABERMAN 36897177, LAWRENCE
2017-10709 12/20/2017 HUSCH BLACKWELL LLP
2017-10710 12/20/2017 LAW OFFICE OF RUBIN FRANCO JR
2017-10711 12/20/2017 RUTAN & TUCKER LLP

2017-10712 12/20/2017 ULMER & BERNE LLP
2017-10713 12/21/2017 Doe J
2017-10714 12/21/2017 Jennifer Bellis, Esq

2017-10715 12/21/2017 HMS Countway Library of Medicine
2017-10716 12/21/2017 Wood's High Mountain Distillery
2017-10717 12/21/2017 Eisai Inc.
2017-10719 12/21/2017 NE Scientific LLC
2017-10720 12/21/2017 LSI SOLUTIONS, INC
2017-10721 12/21/2017 TROUTMAN SANDERS
2017-10722 12/21/2017 TROUTMAN SANDERS

2017-10723 12/21/2017 EZPrint Supplies
2017-10724 12/21/2017 Registrar Corp

2017-10727 12/21/2017 FOI Services, Inc.
2017-10728 12/21/2017 FOI Services, Inc.
2017-10729 12/21/2017 FOI Services, Inc.

2017-10730 12/21/2017 Ativa Medical
2017-10731 12/21/2017 Registrar Corp

2017-10732 12/21/2017 Brian J. Wanca, J.D., P.C.
2017-10733 12/21/2017 FOI Services, Inc.
2017-10734 12/21/2017 FDA NEWS
2017-10735 12/21/2017 FOI Services, Inc.

2017-10736 12/21/2017 Regivet BV
2017-10738 12/21/2017 LIFE EXTENSION
2017-10739 12/21/2017 FOIA GROUP INC

2017-10740 12/21/2017 FDAAWARE
2017-10741 12/21/2017 FOI Services, Inc.
2017-10742 12/21/2017 McCULLOCH, LANCE

2017-10747 12/21/2017 HOGAN LOVELLS US LLP

2017-10749 12/22/2017 Nature's Way Product
2017-10752 12/22/2017 Zoetis Inc.
2017-10753 12/22/2017 FOI Services, Inc.

2017-10754 12/22/2017 FDA NEWS
2017-10755 12/22/2017 FDA NEWS
2017-10756 12/22/2017 FDANEWS
2017-10757 12/22/2017 FDA NEWS
2017-10758 12/22/2017 FDA NEWS
2017-10759 12/22/2017 FDA NEWS
2017-10760 12/22/2017 FDA NEWS
2017-10761 12/22/2017 FOI Services, Inc.
2017-10762 12/22/2017 FDA NEWS
2017-10763 12/22/2017 FDANEWS
2017-10764 12/22/2017 FDA NEWS
2017-10765 12/22/2017 FDANEWS
2017-10766 12/22/2017 FDA NEWS
2017-10767 12/22/2017 FDA NEWS
2017-10768 12/22/2017 FDA NEWS
2017-10769 12/22/2017 FDA NEWS
2017-10770 12/22/2017 FDA NEWS
2017-10771 12/22/2017 FDANEWS
2017-10772 12/22/2017 M SQUARED ASSOCIATES INC
2017-10773 12/22/2017 John Ray
2017-10774 12/22/2017 Fresenius Kabi USA LLC
2017-10775 12/22/2017 NORTHCOAST RESEARCH

2017-10776 12/22/2017 Doe J
2017-10777 12/22/2017 Capstone Development Company
2017-10780 12/22/2017 FOI Services, Inc.
2017-10781 12/22/2017 SIMON LAW FIRM PC
2017-10782 12/22/2017 SIMON LAW FIRM PC

2017-10783 12/22/2017 MUCKROCK NEWS
2017-10784 12/22/2017 MUCKROCK NEWS
2017-10785 12/22/2017 MUCKROCK NEWS

2017-10786 12/26/2017 Datavant
2017-10787 12/26/2017 Datavant
2017-10788 12/26/2017 Datavant
2017-10789 12/26/2017 Datavant
2017-10790 12/26/2017 Datavant
2017-10791 12/26/2017 Datavant
2017-10792 12/26/2017 Datavant
2017-10793 12/26/2017 Datavant
2017-10794 12/26/2017 Datavant
2017-10795 12/26/2017 Datavant
2017-10796 12/26/2017 FOIA GROUP INC
2017-10797 12/26/2017 FOIA GROUP INC
2017-10798 12/26/2017 FOIA GROUP INC
2017-10799 12/26/2017 FOIA GROUP INC
2017-10800 12/26/2017 FOIA GROUP INC
2017-10801 12/26/2017 FOIA GROUP INC
2017-10802 12/27/2017 FOI Services, Inc.

2017-10803 12/27/2017 FOLEY & LARDNER LLP
2017-10804 12/27/2017 Zoetis Inc.

2017-10805 12/27/2017 Knudson, Lawrence A

2017-10807 12/27/2017 US WorldMeds, LLC
2017-10808 12/27/2017 Sterigenics

2017-10809 12/28/2017 Laser Pharmaceuticals, LLC
2017-10811 12/28/2017 Patheon Biologics LLC
2017-10812 12/28/2017 RBC
2017-10813 12/28/2017 Arteriocyte, Inc d/b/a Compass Biomedical
2017-10814 12/28/2017 Center for Science in the Public Interest
2017-10815 12/29/2017 MARKETWATCH FROM DOW JONES

2017-10816 12/29/2017 FOI Services, Inc.
2017-10817 12/29/2017 Ceribell, Inc.
2017-10818 12/29/2017 Jeremy Jarmon
2017-10819 12/29/2017 Ceribell, Inc.

2017-10821 12/29/2017 Davidia Healthtech, LLC
2017-10822 12/29/2017 Susan Alpert
2017-8357 10/02/2017 COPPER RIVER SEAFOOD
2017-8358 10/02/2017 DCCC
STATE OF CALIFORNIA DEPARTMENT OF CONSUMER
2017-8359 10/02/2017 AFFAIRS
2017-8360 10/02/2017 MCS GROUP INC
2017-8361 10/02/2017 GREENER BURKE ET AL
2017-8362 10/02/2017 Gizmodo Media Group
2017-8363 10/02/2017 Epic Risk Solutions Ltd
2017-8364 10/02/2017 Spruce Point Capital Management
2017-8365 10/02/2017 David Michel
2017-8366 10/02/2017 Abigail Lee

2017-8367 10/02/2017 MERCK & CO., INC.
2017-8368 10/02/2017 MERCK & CO., INC.
2017-8369 10/02/2017 MERCK & CO., INC.
2017-8370 10/02/2017 MERCK & CO., INC.
2017-8371 10/02/2017 MERCK & CO., INC.
2017-8372 10/02/2017 MERCK & CO., INC.
2017-8373 10/02/2017 MERCK & CO., INC.
2017-8374 10/02/2017 MERCK & CO., INC.
2017-8375 10/02/2017 MERCK & CO., INC.
2017-8376 10/02/2017 MERCK & CO., INC.
2017-8377 10/02/2017 MERCK & CO., INC.
2017-8378 10/02/2017 MERCK & CO., INC.
2017-8379 10/02/2017 MERCK & CO., INC.
2017-8380 10/02/2017 MERCK & CO., INC.
2017-8381 10/02/2017 MERCK & CO., INC.
2017-8382 10/02/2017 Justin Glawe
2017-8383 10/02/2017 Justin Glawe
2017-8384 10/02/2017 Justin Glawe
2017-8385 10/02/2017 ABC NEWS
2017-8386 10/02/2017 Pegasus Laboratories, Inc.
2017-8387 10/02/2017 Registrar Corp
2017-8388 10/02/2017 Krensavage Asset Management LLC

2017-8390 10/02/2017 HOEFLE PHOENIX GORMLEY & ROBERTS PA

2017-8391 10/02/2017 LSI Solutions Inc.
2017-8392 10/02/2017 McGartland Law Firm, PLLC
2017-8393 10/02/2017 Kaiser Health News
2017-8394 10/02/2017 FOI Services, Inc.
2017-8395 10/02/2017 Morgan Stanley
2017-8396 10/02/2017 ANAPOLWEISS
2017-8397 10/02/2017 Wells International Marketing Group

2017-8398 10/02/2017 Avery Dooley & Noone
2017-8399 10/02/2017 KING & SPALDING
2017-8400 10/02/2017 BASF Colors & Effects
2017-8401 10/02/2017 BLOOMBERG NEWS

2017-8402 10/02/2017 FULD & COMPANY INC
2017-8403 10/02/2017 Charles White
2017-8404 10/02/2017 FOI Services, Inc.
2017-8405 10/02/2017 FOI Services, Inc.
2017-8406 10/02/2017 Wagner Solutions, LLC

2017-8410 10/02/2017 Scopia Capital
2017-8411 10/02/2017 Steptoe & Johnson LLP
2017-8412 10/02/2017 Coherus BioSciences Inc

2017-8413 10/02/2017 BALL & MCCANN
2017-8414 10/02/2017 The Washington Post
2017-8415 10/02/2017 ROBERT W. BAIRD & CO INC
2017-8416 10/02/2017 PAR Pharmaceutical

2017-8417 10/02/2017 ArthroCleanse
2017-8418 10/02/2017 ArthroCleanse
2017-8420 10/02/2017 KETTLE MAGAZINE

2017-8421 10/02/2017 ROBERT W. BAIRD & CO INC
2017-8422 10/02/2017 Doe J
2017-8423 10/02/2017 HOLTZMAN VOGELJJOSEFIAK ET AL
2017-8424 10/02/2017 Doe J
2017-8425 10/02/2017 Andrews Thornton Higgins Razmara, LLP

2017-8428 10/02/2017 PALADINO #488269/590, BRIAN
2017-8429 10/02/2017 BEVERIDGE & DIAMOND PC
2017-8430 10/03/2017 CHRISTOPHER TRAINOR & ASSOCIATES
2017-8431 10/03/2017 FDA NEWS
2017-8432 10/03/2017 Briarpatch Enterprises, Inc

2017-8434 10/03/2017 Liggett Group LLC
2017-8435 10/03/2017 Markos, Christopher
2017-8436 10/03/2017 FDAAWARE
2017-8437 10/03/2017 FDAAWARE
2017-8438 10/03/2017 FDAAWARE
2017-8439 10/03/2017 OptMed
2017-8440 10/03/2017 Jigita Patel

2017-8441 10/03/2017 Shiraz Agichtein
2017-8442 10/03/2017 David Jones

2017-8443 10/03/2017 FULD & COMPANY INC
2017-8444 10/03/2017 German Entrepreneurship GmbH
2017-8445 10/03/2017 CFIC US
2017-8446 10/03/2017 COOLEY LLP
2017-8447 10/03/2017 Registrar Corp
2017-8448 10/03/2017 BLOOMBERG NEWS
2017-8450 10/03/2017 BLOOMBERG NEWS
2017-8452 10/03/2017 Wendy Banka

2017-8454 10/03/2017 EpiSource, LLC

2017-8455 10/03/2017 Axinn LLP
2017-8456 10/03/2017 American Eagle Instruments, Inc.
2017-8457 10/03/2017 Universal Nutrition
2017-8458 10/03/2017 Wendy Banka
2017-8459 10/03/2017 Wendy Banka
2017-8460 10/03/2017 Wendy Banka

2017-8461 10/03/2017 RAY THOMPSON
2017-8462 10/03/2017 RAY THOMPSON

2017-8463 10/03/2017 GOLDBERG & GOLDBERG
2017-8464 10/03/2017 Wendy Banka

2017-8465 10/03/2017 Greenberg Traurig, LLP
2017-8466 10/03/2017 Wendy Banka

2017-8467 10/03/2017 MERCK & CO., INC.
2017-8468 10/03/2017 Wendy Clark
2017-8469 10/03/2017 Wendy Banka
2017-8470 10/03/2017 FDA NEWS
2017-8471 10/03/2017 Wendy Banka
2017-8472 10/03/2017 Wendy Banka

2017-8473 10/03/2017 Wendy Banka
2017-8474 10/03/2017 Wendy Banka
2017-8475 10/03/2017 Chickasaw Nation Industries, Inc.
2017-8476 10/03/2017 FDA NEWS

2017-8477 10/03/2017 Liggett Group LLC
2017-8478 10/03/2017 April Hernandez (JHU Student)
2017-8479 10/03/2017 RAY THOMPSON
2017-8480 10/03/2017 FDA NEWS
2017-8482 10/03/2017 RAY THOMPSON
2017-8483 10/03/2017 The Miller Firm LLC
2017-8484 10/03/2017 FDA NEWS

2017-8485 10/03/2017 RAY THOMPSON
2017-8486 10/03/2017 FDA NEWS

2017-8487 10/03/2017 PUBLIC CITIZEN
2017-8488 10/03/2017 Wendy Banka

2017-8489 10/03/2017 Beveridge & Diamond, PC
2017-8490 10/03/2017 Campbell School of Business, Berry College
2017-8491 10/03/2017 RAI Services Company
2017-8492 10/03/2017 RAY THOMPSON
2017-8493 10/03/2017 FOIA GROUP INC

2017-8494 10/03/2017 FOI Services, Inc.
2017-8496 10/03/2017 RAY THOMPSON

2017-8497 10/03/2017 RAY THOMPSON
2017-8499 10/03/2017 FDA NEWS
2017-8500 10/03/2017 FDA NEWS

2017-8503 10/03/2017 FDANEWS
2017-8504 10/03/2017 FDA NEWS

2017-8505 10/03/2017 FDA NEWS
2017-8506 10/03/2017 FDA NEWS
2017-8507 10/03/2017 FDA NEWS
2017-8508 10/03/2017 FDA NEWS
2017-8509 10/03/2017 FDA NEWS
2017-8510 10/03/2017 FDA NEWS
2017-8511 10/03/2017 FDA NEWS
2017-8512 10/03/2017 FDA NEWS

2017-8513 10/03/2017 COTCHETT, PITRE, SIMON, & MCCARTHY
2017-8514 10/04/2017 MERCK & CO., INC.
2017-8515 10/04/2017 Kenner Nygaard DeMarea Kendall LLC
2017-8516 10/04/2017 UNIVERSITY OF UTAH
2017-8517 10/04/2017 Sacramento Business Journal

2017-8518 10/04/2017 Robbins Geller Rudman & Dowd LLP
2017-8519 10/04/2017 FOI Services, Inc.
2017-8520 10/04/2017 FOI Services, Inc.
2017-8521 10/04/2017 FOI Services, Inc.
2017-8522 10/04/2017 Hatfield, Susan P
2017-8524 10/04/2017 FOI Services, Inc.
2017-8525 10/04/2017 Ocean Genome Legacy

2017-8526 10/04/2017 Lawson & Weitzen LLP
2017-8527 10/04/2017 Nuseed Americas
2017-8528 10/04/2017 Carepoint Healthcare LLC (dba Carepoint Pharmacy)
2017-8529 10/04/2017 PRA Health Sciences

2017-8530 10/04/2017 SAFE FOODS CORPORATION
2017-8531 10/04/2017 Scopelitis Garvin Light Hanson & Feary
2017-8532 10/04/2017 THOMAS SMITH
2017-8533 10/04/2017 wesley inman
2017-8534 10/04/2017 FDAAWARE

2017-8535 10/04/2017 FOI Services, Inc.
2017-8536 10/04/2017 FDAAWARE

2017-8537 10/04/2017 Nuseed Americas
2017-8539 10/04/2017 Hagerman, Emily

2017-8540 10/04/2017 Swedish Cancer Institute
2017-8541 10/04/2017 Oriole Advisors LLC
2017-8542 10/04/2017 FOI Services, Inc.
2017-8543 10/04/2017 Katie Kerfoot Wells Fargo

2017-8544 10/04/2017 OraMetrix, Inc
2017-8545 10/04/2017 Kristin Wise

2017-8546 10/04/2017 FOI Services, Inc.
2017-8547 10/04/2017 FOI Services, Inc.
2017-8548 10/04/2017 Dexcom, Inc.
2017-8549 10/04/2017 Core-Rx Communications
2017-8550 10/04/2017 Orchard View Capital Advisors LP
2017-8551 10/04/2017 Srinivas Gurram
2017-8552 10/04/2017 ISSAR THERAPEUTICS

2017-8558 10/04/2017 FOI Services, Inc.
2017-8559 10/04/2017 FDAAWARE
2017-8560 10/04/2017 PPTA
2017-8561 10/04/2017 POINT 72 ASSET MANAGEMENT LP
2017-8562 10/04/2017 NUTRASOURCE INC
2017-8563 10/04/2017 ADELMAN HIRSCH ET AL
2017-8564 10/04/2017 MUCKROCK
2017-8565 10/04/2017 Manzoor Law Firm, Inc
2017-8566 10/04/2017 BRAYTON PURCELL LLP
2017-8567 10/04/2017 Sysco

2017-8568 10/04/2017 QUADE & ASSOCIATES PLC
2017-8570 10/04/2017 ALM 30140-298, ROBERT
2017-8571 10/04/2017 HILLTOP RESEARCH INC
2017-8573 10/05/2017 FOI Services, Inc.
2017-8574 10/05/2017 Lifeway Foods, Inc.

2017-8575 10/05/2017 Allen Medical Systems, Inc.
2017-8576 10/05/2017 Gregory, Sharon
2017-8580 10/05/2017 FOI Services, Inc.
2017-8581 10/05/2017 CRISPR Therapeutics
2017-8584 10/05/2017 Medela LLC
2017-8585 10/05/2017 Kai Li
2017-8586 10/05/2017 FOI Services, Inc.
2017-8589 10/05/2017 Almirall, S.A.
2017-8590 10/05/2017 Microbiological Consulting, LLC

2017-8592 10/05/2017 Sean Donohue

2017-8593 10/05/2017 Jennifer Kempker
2017-8594 10/05/2017 Paula A. Moynahan, MD
2017-8595 10/05/2017 CR BARD INC

2017-8598 10/05/2017 Zydus Pharmaceuticals USA Inc.
2017-8599 10/05/2017 Dexcom, Inc.
2017-8600 10/05/2017 Marler Clark Law Firm
2017-8601 10/05/2017 VALEANT CANADA LP
2017-8602 10/05/2017 NALSAR, Hyderabad

2017-8603 10/05/2017 COVIDIEN
2017-8604 10/05/2017 Huvepharma, Inc.
2017-8605 10/05/2017 THE WALL STREET JOURNAL

2017-8606 10/05/2017 Doe J
2017-8608 10/05/2017 FOI Services, Inc.
2017-8609 10/05/2017 WELLS FARGO
2017-8610 10/05/2017 Manoj Garg

2017-8611 10/05/2017 TSG
2017-8612 10/05/2017 Registrar Corp
2017-8613 10/05/2017 Registrar Corp
2017-8614 10/05/2017 PUBLIC CITIZEN

2017-8615 10/05/2017 AidennLair Capital
2017-8616 10/05/2017 KITE LAKE CAPITAL
2017-8617 10/05/2017 Registrar Corp
2017-8618 10/05/2017 Susquehanna Financial Group
2017-8619 10/05/2017 UNITED FIRST PARTNERS LLC
2017-8620 10/05/2017 FOI Services, Inc.

The University of Texas Health Science Center at
2017-8621 10/05/2017 Houston
2017-8625 10/05/2017 BLOOMBERG NEWS
2017-8626 10/06/2017 PBM Nutritionals LLC

2017-8627 10/06/2017 Aspen Surgical
2017-8628 10/06/2017 Prateek Goyal
2017-8629 10/06/2017 ACADIA Pharmaceuticals Inc.

2017-8630 10/06/2017 Quad Group
2017-8631 10/06/2017 FOI Services, Inc.
2017-8632 10/06/2017 FOI Services, Inc.

2017-8633 10/06/2017 Hassan A. Shah
2017-8634 10/06/2017 Reuters News
2017-8635 10/06/2017 REGENESIS BIOMEDICAL INC
2017-8636 10/06/2017 Pendley, Baudin & Coffin, L.L.P.
2017-8637 10/06/2017 BLOOMBERG NEWS

Michael Tanner - I teach Bioengineering at Wayne
2017-8638 10/06/2017 State University
2017-8639 10/06/2017 Ascendant Manufacturing Solutions LLC
2017-8640 10/10/2017 OFW LAW

2017-8641 10/10/2017 Inventia Healthcare Private limited
2017-8642 10/10/2017 Scopia Capital
2017-8643 10/10/2017 Scopia Capital
2017-8644 10/10/2017 INSYS THERAPEUTICS INC
2017-8645 10/10/2017 Martin, Kane & Kuper, Esqs.

2017-8646 10/10/2017 Rita Watkins
2017-8647 10/10/2017 FDAZILLA

2017-8649 10/10/2017 Doe J
2017-8650 10/10/2017 Centurion Medical Products Corporation

2017-8653 10/10/2017 Jackson Schreiner LLC
2017-8654 10/10/2017 SALAMANDRA LLC
2017-8655 10/10/2017 Center for the Study of Empathic Therapy
2017-8656 10/10/2017 Pennock Law Firm

2017-8659 10/10/2017 PALISADES DENTAL

2017-8661 10/10/2017 Jubilant Draximage Inc.
2017-8662 10/10/2017 Pennock Law Firm

2017-8664 10/10/2017 Nicholas Kischuk

2017-8665 10/10/2017 FOI Services, Inc.
2017-8666 10/10/2017 LifeWave Biomedical, Inc
2017-8667 10/10/2017 Rakshana Balakrishnan
2017-8668 10/10/2017 Anthony Roberts

2017-8669 10/10/2017 FOI Services, Inc.
2017-8670 10/10/2017 MIZUHO SECURITIES USA INC
2017-8671 10/10/2017 FOI Services, Inc.

2017-8672 10/10/2017 KING & SPALDING
2017-8673 10/10/2017 FOI Services, Inc.

2017-8675 10/10/2017 G&W LABORATORIES INC
2017-8676 10/10/2017 FDAAWARE
2017-8677 10/10/2017 FOI Services, Inc.
2017-8678 10/10/2017 NEW YORK TIMES

2017-8679 10/10/2017 Saptalis Pharmaceuticals, LLC
2017-8680 10/10/2017 Altaire Pharmaceuticals, Inc.

2017-8682 10/10/2017 Datavant
2017-8683 10/10/2017 James Skinner
2017-8684 10/10/2017 lory daddario
2017-8685 10/10/2017 Biogen Inc.
2017-8686 10/10/2017 LOEB & LOEB LLP

2017-8687 10/10/2017 Ascend Laboratories LLC
2017-8688 10/10/2017 GOLDMAN SACHS

2017-8689 10/10/2017 NSF International
2017-8690 10/10/2017 Chengyu Shen
2017-8691 10/10/2017 FDAAWARE
2017-8692 10/10/2017 FOI Services, Inc.

2017-8693 10/10/2017 Novast Laboratories
2017-8694 10/10/2017 FOI Services, Inc.
2017-8695 10/10/2017 Cerium Pharmaceuticals, Inc.

2017-8696 10/10/2017 Spark Capital Advisors (I) Private Limited
2017-8697 10/10/2017 Citadel Invesment Group
2017-8698 10/10/2017 RICHMAN LAW GROUP
2017-8699 10/10/2017 THOMPSON HINE LLP

2017-8700 10/10/2017 Doe J
2017-8701 10/10/2017 CORNING INC
2017-8702 10/10/2017 BURKHOLD, MELANIE
2017-8703 10/10/2017 NATIONAL ASSOCIATION FO BIOMEDICAL RESEARCH

2017-8705 10/10/2017 Mainetti Mainetti & O'Connor, PC

2017-8706 10/10/2017 Doe J
2017-8707 10/10/2017 Doe J
2017-8708 10/10/2017 Doe J

2017-8709 10/10/2017 STONE, ANNE
2017-8711 10/10/2017 PROPUBLICA
2017-8712 10/10/2017 WASHINGTON STATE UNIVERSITY

2017-8714 10/10/2017 UNIV OF KENTUCKY MAKRKEY CANCER CENTER
2017-8717 10/10/2017 WADE CLARK MULCAHY

2017-8719 10/11/2017 FOI Services, Inc.
2017-8720 10/11/2017 Duke Global Value Chains Center
2017-8721 10/11/2017 INOVA HEALTH SYSTEM
2017-8722 10/11/2017 CITIGROUP
2017-8723 10/11/2017 FDAZILLA

2017-8724 10/11/2017 Braster S.A.
2017-8725 10/11/2017 FOI Services, Inc.
2017-8726 10/11/2017 CPC Scientific Inc.

2017-8727 10/11/2017 FOI Services, Inc.
2017-8728 10/11/2017 Brian Hodges
2017-8729 10/11/2017 FOIA GROUP INC
2017-8730 10/11/2017 FOI Services, Inc.
2017-8731 10/11/2017 Akerman LLP
2017-8732 10/11/2017 THOMSON REUTERS

2017-8734 10/11/2017 MEDTRONIC
2017-8735 10/11/2017 SteriMax Inc

2017-8736 10/11/2017 GeneYork Pharmaceuticals Group LLC
2017-8737 10/11/2017 Quality Solutions and Support, LLC
2017-8738 10/11/2017 STRYKER INSTRUMENTS
2017-8739 10/11/2017 Toni Guy
2017-8740 10/11/2017 SANOFI
2017-8741 10/11/2017 Reveal Pharmaceuticals Inc.
2017-8742 10/11/2017 LACHMAN CONSULTANT SERVICES, INC.
2017-8743 10/11/2017 POINT 72 ASSET MANAGEMENT LP
2017-8744 10/11/2017 TULINO, NICOLETTA
2017-8745 10/11/2017 PROPUBLICA
2017-8746 10/11/2017 OCONNOR 199579, NYKA
2017-8747 10/11/2017 ALSTON & BIRD LLP

2017-8749 10/11/2017 HOLLAND & KNIGHT LLP
2017-8750 10/11/2017 LAW OFFICES OF DANIEL R MORDARSKI LLC

2017-8751 10/11/2017 KITE LAKE CAPITAL
2017-8752 10/11/2017 KRAFT HEINZ

Story of Stuff Project & Courage Campaign
2017-8753 10/12/2017 Institute
2017-8754 10/12/2017 Akerman LLP

2017-8755 10/12/2017 Foiante Gras
2017-8756 10/12/2017 CFR Services Inc

2017-8757 10/12/2017 Foiante Gras
2017-8758 10/12/2017 CFR Services Inc
2017-8759 10/12/2017 FDAZILLA
2017-8760 10/12/2017 CFR Services, Inc.

2017-8761 10/12/2017 CFR Services, Inc.
2017-8762 10/12/2017 CFR Services Inc
2017-8763 10/12/2017 CFR Services Inc.

2017-8765 10/12/2017 PBM Nutritionals LLC
2017-8766 10/12/2017 CFR Services Inc.

2017-8767 10/12/2017 Stryker Sustainability Solutions
2017-8768 10/12/2017 CFR Services Inc
2017-8769 10/12/2017 Doe J
2017-8770 10/12/2017 MEI Pharma, Inc.
2017-8771 10/12/2017 Sarah Rappaport
2017-8773 10/12/2017 Ranee Singleton

2017-8774 10/12/2017 FOI Services, Inc.
2017-8775 10/12/2017 FOIA GROUP INC
2017-8776 10/12/2017 implicity
2017-8777 10/12/2017 implicity
2017-8778 10/12/2017 Achaogen.com
2017-8779 10/12/2017 Department of Health of Hong Kong SAR
2017-8780 10/12/2017 Morgan Stanley

2017-8781 10/12/2017 Deven Sanon
2017-8782 10/12/2017 Berkshire Sterile Manufacturing, Inc.

2017-8784 10/12/2017 PharmaTech LLC
2017-8785 10/12/2017 FDAble LLC
2017-8786 10/12/2017 BlueMountain Capital

2017-8787 10/12/2017 Kashiv Pharma, LLC
2017-8790 10/12/2017 DUKE GLOBAL VALUE CHAIRS CENTER

2017-8791 10/12/2017 Andrews & Thornton
2017-8793 10/13/2017 DUKE UNIVERSITY
2017-8794 10/13/2017 MORRISON MAHONEY LLP

2017-8796 10/13/2017 BLOOMBERG NEWS
2017-8797 10/13/2017 JMPG

2017-8798 10/13/2017 KCI USA, Inc.
2017-8799 10/13/2017 FOI Services, Inc.
2017-8800 10/13/2017 Moab Partners
2017-8801 10/13/2017 FOI Services, Inc.
2017-8802 10/13/2017 Glenmark Pharmaceuticals Inc., USA
2017-8804 10/13/2017 Admetsys
2017-8805 10/13/2017 Upsher-Smith Laboratories, Inc.
2017-8806 10/13/2017 Admetsys
2017-8807 10/13/2017 FDAZILLA

2017-8809 10/13/2017 Citigroup Global Markets India Private Limited
2017-8810 10/13/2017 Robert Nelson, MD
2017-8811 10/13/2017 Citi
2017-8812 10/13/2017 AMRI
2017-8813 10/13/2017 Cook Medical
2017-8814 10/13/2017 PERKINS COIE
2017-8815 10/13/2017 BEAN KINNEY & KORMAN PC
2017-8816 10/13/2017 Gregory Law Firm, PLLC
2017-8817 10/13/2017 BOYLE SHAUGHNESSY LAW PC

2017-8818 10/13/2017 BESMED HEALTH BUSINESS CORP
2017-8819 10/13/2017 Octapharma USA, Inc.
2017-8820 10/16/2017 Cecillia Freeman
2017-8821 10/16/2017 Anthony Borisow

2017-8822 10/16/2017 Agios Pharmaceuticals
2017-8823 10/16/2017 Patient Centered Care Advocacy Group Inc.
2017-8824 10/16/2017 BioFire Diagnostics, LLC
2017-8825 10/16/2017 Krishna Agravat

2017-8826 10/16/2017 FOIA GROUP INC
2017-8829 10/16/2017 BLOOMBERG NEWS

2017-8838 10/16/2017 QFI
2017-8839 10/16/2017 UCSF Benioff Childrens Oakland Hospital

2017-8842 10/16/2017 Forus Health Pvt. Ltd
2017-8845 10/16/2017 S.Albert Edwards,Pharm.D., LTD
2017-8847 10/16/2017 PROPUBLICA

2017-8857 10/16/2017 THERAVANCE BIOPHARMA US INC

2017-8858 10/16/2017 Elizabeth Carney
2017-8859 10/16/2017 Global Clincal Research

2017-8861 10/16/2017 THOMSON REUTERS
2017-8862 10/16/2017 Rocket Medical Plc
2017-8864 10/16/2017 FOI Services, Inc.
2017-8867 10/16/2017 MERCER UNIVERSITY
2017-8868 10/16/2017 Aylstock, Witkin, Kreis & Overholtz, PLLC
2017-8869 10/16/2017 KEYS 22458017, CLAY
2017-8870 10/16/2017 RYTHM SAS
2017-8871 10/16/2017 US WorldMeds, LLC
2017-8872 10/16/2017 JAMIESON NATURAL SOURCES

2017-8873 10/16/2017 STUTE, HANK
2017-8875 10/16/2017 REMEDY PHARMACEUTICALS
2017-8876 10/16/2017 SEA SPINE
2017-8878 10/16/2017 SIEGEL BRILL PA
2017-8879 10/16/2017 ALSTON & BIRD LLP
2017-8880 10/16/2017 ROCKY MOUNTAIN POISON DRUG CTR
2017-8881 10/16/2017 PEPPER HAMILTON LLP

2017-8882 10/16/2017 Mainetti Mainetti & O'Connor, PC
2017-8899 10/16/2017 FOI Services, Inc.
2017-8900 10/16/2017 FOI Services, Inc.
2017-8901 10/16/2017 FOI Services, Inc.
2017-8902 10/16/2017 FOI Services, Inc.
2017-8903 10/16/2017 FDA NEWS
2017-8904 10/16/2017 FDA NEWS
2017-8905 10/17/2017 Organic Defoamer Group
2017-8906 10/17/2017 White and Williams LLP

2017-8907 10/17/2017 MERCK & CO., INC.
2017-8908 10/17/2017 MERCK & CO., INC.
2017-8909 10/17/2017 MERCK & CO., INC.
2017-8910 10/17/2017 MERCK & CO., INC.
2017-8911 10/17/2017 MERCK & CO., INC.
2017-8912 10/17/2017 MERCK & CO., INC.
2017-8913 10/17/2017 MERCK & CO., INC.
2017-8914 10/17/2017 MERCK & CO., INC.
2017-8915 10/17/2017 MERCK & CO., INC.
2017-8916 10/17/2017 FOIA GROUP INC
2017-8917 10/17/2017 FOIA GROUP INC
2017-8918 10/17/2017 FOIA GROUP INC
2017-8919 10/17/2017 ODAN LABORATORIES LTD
2017-8920 10/17/2017 Laboratorios Rubió, S.A.

2017-8923 10/17/2017 Allison Biszantz
2017-8924 10/17/2017 Atlantic Pharmaceuticals, Inc.
2017-8925 10/17/2017 CM Cooper and Associates

2017-8926 10/17/2017 Xeris Pharmaceuticals, Inc.
2017-8928 10/17/2017 University of Helsinki (FINLAND)
2017-8929 10/17/2017 Watson llp

2017-8931 10/17/2017 THOMSON REUTERS

2017-8932 10/17/2017 Craig Watson
2017-8934 10/17/2017 Ricoh Company, Ltd.
2017-8935 10/17/2017 MARSH, RICKARD & BRYAN, PC

2017-8936 10/17/2017 Reuters News
2017-8937 10/17/2017 FOI Services, Inc.
2017-8938 10/17/2017 Rawls Law Group, P.C.
2017-8939 10/17/2017 FOI Services, Inc.
2017-8940 10/17/2017 NIMIO AB
2017-8941 10/17/2017 Epigenomics AG
2017-8942 10/17/2017 Donald Farber
2017-8943 10/17/2017 Daniel Daniele
2017-8944 10/18/2017 Eric M. Burse
FLORIDA INTERNATIONAL UNIVERSITY/UNIVERSITY
2017-8945 10/18/2017 OUTREACH
2017-8946 10/18/2017 FULD & COMPANY INC
2017-8947 10/18/2017 BresoTEC Inc.
2017-8948 10/18/2017 Darren Curtis
2017-8949 10/18/2017 WECT News

2017-8952 10/18/2017 Reuters News
2017-8954 10/18/2017 ANNE STONE

2017-8955 10/18/2017 FDAZILLA
2017-8956 10/18/2017 Park, Nicky
2017-8957 10/18/2017 Tracey and Fox
2017-8958 10/18/2017 Association for Truth in Pet Food
2017-8959 10/18/2017 Justin Glawe
2017-8960 10/18/2017 Justin Glawe

2017-8961 10/18/2017 OneSource Regulatory
2017-8962 10/18/2017 Bell International Laboratories
2017-8963 10/18/2017 Peter Eriksson
2017-8964 10/18/2017 Unger Consulting

2017-8966 10/18/2017 Quanta Dialysis Technologies
2017-8969 10/18/2017 CAM
2017-8971 10/18/2017 Doe J
2017-8972 10/18/2017 B.Braun Medical Inc.
2017-8973 10/18/2017 ENVIRONMENTAL DEFENSE FUND
2017-8974 10/18/2017 FDAble LLC
2017-8975 10/18/2017 FDAZILLA
2017-8976 10/18/2017 MERCK & CO., INC.
2017-8977 10/18/2017 MERCK & CO., INC.
2017-8978 10/18/2017 MERCK & CO., INC.
2017-8979 10/18/2017 MARTIN HARDING ET AL
2017-8980 10/18/2017 MERCK & CO., INC.
2017-8981 10/18/2017 MERCK & CO., INC.
2017-8982 10/18/2017 MERCK & CO., INC.
2017-8984 10/18/2017 MERCK & CO., INC.
2017-8985 10/18/2017 MERCK & CO., INC.
2017-8986 10/18/2017 MERCK & CO., INC.
2017-8987 10/18/2017 MERCK & CO., INC.
2017-8988 10/18/2017 MERCK & CO., INC.
2017-8989 10/18/2017 MERCK & CO., INC.
2017-8991 10/18/2017 MERCK & CO., INC.
2017-8992 10/18/2017 MERCK & CO., INC.
2017-8995 10/18/2017 DCCC
2017-8996 10/18/2017 COHEN & MALAD LLP
2017-8997 10/18/2017 Doe J

2017-8999 10/19/2017 Henry Ford Health System
2017-9000 10/19/2017 The Clarion-Ledger
2017-9001 10/19/2017 D. E. Shaw & Co.

2017-9002 10/19/2017 RAY THOMPSON
2017-9003 10/19/2017 Oxford Immunotec, Inc.
2017-9004 10/19/2017 Perceptive Advisors
2017-9005 10/19/2017 FDAble LLC
2017-9006 10/19/2017 Friedl, Robert K
2017-9007 10/19/2017 LKGLOBAL
2017-9008 10/19/2017 FDAZILLA
2017-9009 10/19/2017 RUTGERS UNIVERSITY

2017-9010 10/19/2017 Julie Ralph
2017-9011 10/19/2017 CSPI

2017-9012 10/19/2017 FDAble LLC
2017-9014 10/19/2017 FOI Services, Inc.

2017-9016 10/19/2017 Court Express
2017-9017 10/19/2017 Intuitive Surgical, Inc.
2017-9018 10/19/2017 Akorn, Inc.
2017-9019 10/19/2017 Valeant Pharmaceuticals (Bausch Lomb)
2017-9020 10/19/2017 FOI Services, Inc.
2017-9021 10/19/2017 RevMedx, Inc.
2017-9022 10/19/2017 Ascend Laboratories LLC
2017-9023 10/19/2017 PL DEVELOPMENTS
2017-9024 10/19/2017 FOI Services, Inc.
2017-9027 10/19/2017 UNIVERSITY OF ROCHESTER
2017-9028 10/19/2017 Russ Kick

2017-9029 10/19/2017 B. Braun Medical Inc.
2017-9030 10/19/2017 Human Biosciences, Inc.
2017-9031 10/19/2017 eVenus Pharmaceutical Laboratories Inc.

2017-9032 10/19/2017 Global Clincal Research
2017-9033 10/19/2017 RevMedx, Inc.
2017-9034 10/19/2017 FOI Services, Inc.
2017-9036 10/20/2017 Compan Pharmaceuticals
2017-9037 10/20/2017 Capstone Law APC
2017-9038 10/20/2017 Product Quest Manufacturing LLC

2017-9039 10/20/2017 Doe J
2017-9040 10/20/2017 Buzzfeed News
2017-9042 10/20/2017 Chapman, Bruce G
2017-9044 10/20/2017 Missouri School of Journalism

2017-9045 10/20/2017 Anapol Weiss
2017-9046 10/20/2017 Futurism.com

2017-9047 10/20/2017 FOI Services, Inc.
2017-9048 10/20/2017 NORTHGATE TECHNOLOGIES INC
2017-9049 10/20/2017 RevMedx, Inc.
2017-9050 10/20/2017 LOEB & LOEB LLP

2017-9052 10/20/2017 SAVE MART COMPANIES
2017-9053 10/20/2017 STEIN MITCHELL CIPOLLONE BEATO & MISSNER LLP

2017-9054 10/20/2017 EMPLOYERS UNITY LLC

INSTITUTE OF PHARMACOLOGICAL SCIENCES OF SOUTHERN
2017-9056 10/20/2017 SWITZERLAND
2017-9057 10/20/2017 Gregory Law Firm, PLLC
2017-9058 10/20/2017 FDA NEWS

2017-9060 10/20/2017 Embria Health Sciences LLC
2017-9061 10/20/2017 FOLEY HOAG LLP
2017-9062 10/20/2017 BUMA, SHELLEY J

2017-9063 10/23/2017 OLSSON FRANK WEEDA TERMAN MATZ PC
2017-9064 10/23/2017 Doe J
2017-9065 10/23/2017 Morgan Stanley

2017-9066 10/23/2017 FOI Services, Inc.
2017-9067 10/23/2017 FDAZILLA
2017-9068 10/23/2017 World Health Pharmaceutical Group
2017-9069 10/23/2017 Alice Visocchi
2017-9070 10/23/2017 MARSH, RICKARD & BRYAN, PC
2017-9071 10/23/2017 WASHINGTON STATE UNIVERSITY
2017-9072 10/23/2017 Doe J
2017-9073 10/23/2017 LIFE EXTENSION

2017-9074 10/23/2017 UNC-Greensboro
2017-9075 10/23/2017 FOIA Professional Services
2017-9076 10/23/2017 HENSON, J DONALD
2017-9077 10/23/2017 CENTER FOR FOOD SAFETY

2017-9078 10/23/2017 Nova Southeastern University

2017-9081 10/23/2017 Challen Asset Management, LLC
2017-9082 10/23/2017 CAUDILL, RUTHANN

2017-9083 10/23/2017 Nova Southeastern University
2017-9084 10/23/2017 Melissa Chu Lam
2017-9085 10/23/2017 Slayback Pharma LLC
2017-9086 10/23/2017 HERNANDEZ, RAMONA
2017-9087 10/23/2017 DEMOCRATIC SENATORIAL CAMPAIGN COMMITTEE

2017-9089 10/23/2017 Clinton Murphy
2017-9090 10/23/2017 FOIA GROUP INC
2017-9091 10/23/2017 Athenex, Inc.
2017-9092 10/23/2017 NovaSight
2017-9093 10/23/2017 Kerry Robinson
2017-9094 10/23/2017 SKEMA Business School

2017-9095 10/23/2017 Keara Jamieson
2017-9096 10/23/2017 James Alexander Corporation

2017-9098 10/23/2017 LIFE EXTENSION
2017-9099 10/23/2017 FOIA GROUP INC
2017-9100 10/23/2017 Doe J
2017-9101 10/23/2017 WJLA-TV
2017-9102 10/23/2017 FISH & RICHARDSON PC
2017-9105 10/23/2017 Doe J

2017-9108 10/24/2017 Kutahya Porselen San. A.S.
2017-9109 10/24/2017 Christie Medical Holdings,Inc.
2017-9110 10/24/2017 Christie Medical Holdings, Inc
2017-9111 10/24/2017 Doe J
2017-9112 10/24/2017 U.S. Army Medical Research and Materiel Command
2017-9113 10/24/2017 HOUSTON CHRONICLE

2017-9114 10/24/2017 UNIVERSITY OF PENNSYLVANIA
2017-9115 10/24/2017 Raymond James
2017-9116 10/24/2017 CAM
2017-9117 10/24/2017 CAM

2017-9118 10/24/2017 VIRTUOSO SURGICAL
2017-9120 10/24/2017 Justin Glawe
2017-9121 10/24/2017 Pfanstiehl, Inc.
2017-9122 10/24/2017 MERCK & CO., INC.
2017-9124 10/24/2017 JOHNSON & ROCHE ATTYS AT LAW

2017-9125 10/24/2017 Equine Joint Performance Inc
2017-9126 10/24/2017 Akerman LLP
2017-9127 10/24/2017 Enigma Technologies, Inc.

2017-9128 10/24/2017 LAW FIRM OF BARRETT W STETSON
2017-9129 10/24/2017 Doe J
2017-9130 10/25/2017 The Good Food Institute
2017-9131 10/25/2017 Sterne Kessler Goldstein & Fox PLLC

Shenandoah University, Bernard J. Dunn School of
2017-9132 10/25/2017 Pharmacy
2017-9133 10/25/2017 Doe J
2017-9134 10/25/2017 Healthco.
2017-9135 10/25/2017 NIDEK INC
2017-9136 10/25/2017 Waymade PLC

2017-9137 10/26/2017 Doe J
2017-9138 10/26/2017 Surgical Technology Laboratories, Inc
2017-9139 10/26/2017 Michael Lynch
2017-9141 10/26/2017 ROYALTY PHARMA AG
2017-9143 10/26/2017 NBC NEWS
2017-9144 10/26/2017 Biologics Consulting Group, Inc.

2017-9146 10/26/2017 Admetsys

2017-9148 10/26/2017 LoConti Law Group, LLC
2017-9149 10/26/2017 OFW LAW

2017-9150 10/26/2017 Healthco.
2017-9151 10/26/2017 LuTran Inc.

2017-9152 10/26/2017 LATHAM & WATKINS LLP
2017-9153 10/26/2017 Nirmal Bang Equities private limited

2017-9155 10/26/2017 Healthco.
2017-9156 10/26/2017 South Texas Veterans Health Care System
2017-9157 10/26/2017 Morgan Stanley
2017-9158 10/26/2017 Deep Genomics
2017-9159 10/26/2017 Morgan Stanley
2017-9160 10/26/2017 GORDON MANAGEMENT, INC.
2017-9161 10/26/2017 Case Linden PC

2017-9162 10/26/2017 Doe J
2017-9163 10/26/2017 SI-TECHNOLOGY, LLC
2017-9164 10/26/2017 WCSH
2017-9165 10/26/2017 Institute of Innovation Law - UC Hastings
2017-9166 10/26/2017 Aroa Biosurgery
2017-9167 10/26/2017 Deborah Sheffield
2017-9168 10/26/2017 Deborah Sheffield
2017-9169 10/26/2017 Accredo, Inc
2017-9170 10/27/2017 Aroa Biosurgery
2017-9171 10/27/2017 LIFE EXTENSION
2017-9172 10/27/2017 LIFE EXTENSION
2017-9173 10/27/2017 WINSTON & STRAWN LLP

Beasley, Allen, Crow, Methvin, Portis & Miles,
2017-9175 10/27/2017 P.C.
2017-9176 10/27/2017 Contract In-House Counsel and Consultants, LLC
2017-9177 10/27/2017 Boston Scientific Corporation
2017-9178 10/27/2017 ReShape Medical Inc.

2017-9179 10/27/2017 Monteris Medical
2017-9180 10/27/2017 FOI Services, Inc.
2017-9181 10/27/2017 Datavant
2017-9182 10/27/2017 Rochem International Inc.
2017-9183 10/27/2017 G&W Laboratories, Inc.

2017-9184 10/27/2017 Haoyue Zhou
2017-9185 10/27/2017 CINCINNATI SUB-ZERO PRODUCTS INC

2017-9186 10/27/2017 CAM
2017-9187 10/27/2017 Accelerated analytical Labs Inc.

2017-9188 10/27/2017 GRUPPO SINTESI
2017-9189 10/27/2017 Datavant
2017-9190 10/27/2017 FDAZILLA

2017-9191 10/27/2017 REACH Monitor SL
2017-9193 10/27/2017 Cycle Pharmaceuticals
2017-9194 10/27/2017 Cipla USA, Inc.
2017-9195 10/27/2017 Upsher-Smith Laboratories,LLC
2017-9197 10/27/2017 Law Offices of Rahel Goharchin and William Beck

2017-9199 10/27/2017 PATH
2017-9200 10/27/2017 Aristotle Capital Management

2017-9201 10/27/2017 INTERCHEM CORP
2017-9203 10/27/2017 HENRY FORD HOSPITAL
2017-9204 10/27/2017 Healthco.

2017-9207 10/27/2017 G&W LABORATORIES INC
2017-9208 10/30/2017 POMERANTZ LLP
2017-9209 10/30/2017 BUXBAUM DAUE PLLC

2017-9210 10/30/2017 SZAFERMAN LAKIND BLUMSTEIN ET AL
2017-9211 10/30/2017 HOBSON & BRADLEY ATTYS
2017-9213 10/30/2017 Doe J

2017-9215 10/30/2017 FOI Services, Inc.
2017-9217 10/30/2017 FDA NEWS

2017-9218 10/30/2017 Ethicon
2017-9219 10/30/2017 DEKA R&D
2017-9220 10/30/2017 Doe J
2017-9221 10/30/2017 FOI Services, Inc.
2017-9222 10/30/2017 Doe J
2017-9223 10/30/2017 vTv Therapeutics LLC

2017-9225 10/30/2017 NEW YORK TIMES
2017-9226 10/31/2017 FDA NEWS
2017-9227 10/31/2017 FDA NEWS
2017-9228 10/31/2017 FDA NEWS
2017-9229 10/31/2017 FDA NEWS
2017-9230 10/31/2017 FDA NEWS
2017-9231 10/31/2017 FDA NEWS
2017-9232 10/31/2017 FDA NEWS
2017-9233 10/31/2017 FDA NEWS
2017-9234 10/31/2017 FDA NEWS

2017-9235 10/31/2017 FDA NEWS
2017-9236 10/31/2017 FDA NEWS
2017-9237 10/31/2017 FDA NEWS
2017-9238 10/31/2017 FDA NEWS

2017-9239 10/31/2017 FDA NEWS
2017-9240 10/31/2017 FDA NEWS

2017-9241 11/01/2017 Pennock Law Firm LLC
2017-9243 11/01/2017 Morgan Stanley

2017-9244 11/01/2017 ALONSO KRANGLE, LLP
2017-9245 11/01/2017 Laura Zumbrunnen
2017-9246 11/01/2017 Joshua Radbod

2017-9249 11/01/2017 Arden Stoermer
2017-9250 11/01/2017 Markwins
2017-9251 11/01/2017 BLANK ROME LLP

2017-9252 11/01/2017 Eva Schram
2017-9253 11/01/2017 Informa/Natural Products INSIDER
2017-9254 11/01/2017 MIC International Corp.
2017-9255 11/01/2017 Lawrence Paikoff, MD, JD, Law Offices of
2017-9256 11/01/2017 Bio-Recovery, Inc
2017-9257 11/01/2017 Datavant

2017-9258 11/01/2017 Piccolo Medical, Inc.
2017-9259 11/01/2017 Morgan Stanley
2017-9260 11/01/2017 Perez, Madelaine

2017-9261 11/01/2017 LIFE EXTENSION
2017-9262 11/01/2017 LIFE EXTENSION
2017-9263 11/01/2017 Sparacino & Andreson PLLC
2017-9264 11/01/2017 Beth Marchitelli DVM
2017-9265 11/01/2017 Diana Romero
2017-9266 11/01/2017 BIOPHARM INSIGHT
2017-9267 11/01/2017 ENDO PHARMACEUTICALS

2017-9269 11/01/2017 University Hospital Cologne
2017-9270 11/01/2017 UConn Health Center
2017-9271 11/01/2017 UNIVERSITY OF CALIFORNIA SAN FRANCISCO

2017-9273 11/01/2017 DiMonte & Lizak, LLC
2017-9274 11/01/2017 The Denver Post/The Cannabist
2017-9275 11/01/2017 THE HUMANE SOCIETY OF THE UNITED STATES

2017-9276 11/01/2017 Joseph Sandford
2017-9277 11/01/2017 Charles Schierer

2017-9278 11/01/2017 EOI Consulting Group, LLC
2017-9280 11/01/2017 FOI Services, Inc.
2017-9281 11/01/2017 USP - U.S. pharmacopoeia convention
2017-9282 11/01/2017 Upstate New York Poison Center
2017-9283 11/01/2017 NantKwest
2017-9284 11/01/2017 ASHCRAFT & GEREL LLP

2017-9285 11/01/2017 WISLON SONSINI ET AL
2017-9287 11/01/2017 TARO PHARMACEUTICALS USA INC

2017-9288 11/01/2017 BOSLER LAW FIRM PC
2017-9289 11/01/2017 BIO VECTRA INC
2017-9290 11/01/2017 GOMEZ & GOLOMB
2017-9291 11/01/2017 DEYMONAZ, BARBARA
2017-9292 11/01/2017 BAYER US PRODUCT SUPPLY BIOTECH
2017-9293 11/01/2017 KEYS 22458-017, CLAY
2017-9294 11/01/2017 SCOUT, C
2017-9295 11/01/2017 FDA NEWS
2017-9296 11/01/2017 FDA NEWS
2017-9297 11/01/2017 FDA NEWS

2017-9298 11/02/2017 Doe J
2017-9299 11/02/2017 Rebecca Schiffman
2017-9300 11/02/2017 Wilson & Parlett

2017-9301 11/02/2017 Medical Device Resource Corporation
2017-9303 11/02/2017 PuraCap Pharmaceutical, LLC
2017-9304 11/02/2017 State Farm Insurance Company
2017-9305 11/02/2017 Recro Pharma, Inc.
2017-9306 11/02/2017 FOI Services, Inc.
2017-9310 11/02/2017 Huvepharma, Inc.
2017-9312 11/02/2017 EDWARDS LIFESCIENCES (SINGAPORE) Pte Ltd

2017-9314 11/02/2017 FDAZILLA

2017-9315 11/02/2017 Solve Consulting International Pty Ltd
2017-9316 11/02/2017 FOI Services, Inc.

2017-9319 11/02/2017 ORBIMED ADVISORS LLC
2017-9320 11/02/2017 FOI Services, Inc.
2017-9321 11/02/2017 FOI Services, Inc.
Lynn Pinker Cox & Hurst (on behalf of Green Chile
2017-9322 11/02/2017 Concepts, LLC)
2017-9323 11/02/2017 FOI Services, Inc.
2017-9324 11/02/2017 FOI Services, Inc.
2017-9325 11/02/2017 Tracy Fischer
2017-9326 11/02/2017 PEACOCK MYERS PC

2017-9327 11/02/2017 MERCK & CO., INC.
2017-9328 11/02/2017 Raley's
2017-9329 11/02/2017 STERIS CORP
2017-9330 11/02/2017 HILL TOP RESEARCH
2017-9331 11/02/2017 KPTV FOX 12
2017-9332 11/02/2017 KEYS 22458-017, CLAY
2017-9333 11/02/2017 KEYS 22458-017, CLAY
2017-9334 11/02/2017 IMPRIMIS PHARMACEUTICALS
2017-9335 11/02/2017 BELL LEGAL GROUP LLC

2017-9336 11/02/2017 Doe J
2017-9337 11/02/2017 KRAMP, JOHN
2017-9338 11/02/2017 LINCARE INC

2017-9339 11/03/2017 Crawford Healthcare Inc
2017-9340 11/03/2017 MERCK & CO., INC.
2017-9341 11/03/2017 FOI Services, Inc.
2017-9342 11/03/2017 Heidi Weintraub & Associates, LLC

2017-9343 11/03/2017 FOI Services, Inc.
2017-9346 11/03/2017 FDAAWARE
2017-9347 11/03/2017 MERCK & CO., INC.
2017-9348 11/03/2017 FOI Services, Inc.

2017-9349 11/03/2017 The Medicines Company
2017-9350 11/03/2017 Nexgen Pharma, Inc.
2017-9351 11/03/2017 View Point Medical
2017-9352 11/03/2017 Entreprises Importfab

2017-9353 11/03/2017 Doe J
2017-9354 11/03/2017 AKARI Therapeutics PLC

2017-9355 11/03/2017 FDAAWARE
2017-9356 11/03/2017 FDAAWARE
2017-9357 11/03/2017 Doe J

2017-9358 11/03/2017 WESTERN INSTITUTIONAL REVIEW BOARD
2017-9360 11/03/2017 SCHRAM, EVA

2017-9361 11/03/2017 Lincare Holdings
2017-9362 11/03/2017 MUCKROCK NEWS
2017-9363 11/03/2017 MUCKROCK NEWS
2017-9364 11/03/2017 MUCKROCK NEWS

2017-9365 11/03/2017 MUCKROCK NEWS
2017-9366 11/03/2017 MUCKROCK NEWS
2017-9367 11/03/2017 MUCKROCK NEWS
2017-9368 11/03/2017 MUCKROCK NEWS
2017-9369 11/03/2017 MUCKROCK NEWS
2017-9370 11/03/2017 MUCKROCK NEWS
2017-9371 11/03/2017 MUCKROCK NEWS

2017-9372 11/03/2017 CBS NEWS
2017-9373 11/06/2017 TaiDoc Technology Corporation
2017-9374 11/06/2017 Nemoto Kyorindo Co., Ltd.
2017-9376 11/06/2017 Owen McCarthy

2017-9378 11/06/2017 DCCC
2017-9379 11/06/2017 FOI Services, Inc.
2017-9380 11/06/2017 WilMarc Medical
2017-9381 11/06/2017 Kavi Asset Management
2017-9382 11/06/2017 FUJINO, YUKIO

2017-9383 11/06/2017 FOI Services, Inc.
2017-9384 11/06/2017 KING & SPALDING
2017-9385 11/06/2017 KING & SPALDING

2017-9387 11/06/2017 PanAgora Asset Management
2017-9388 11/06/2017 Macleods Pharmaceuticals Limited

2017-9390 11/06/2017 Intertek USA, Inc.
2017-9393 11/06/2017 Baird
2017-9394 11/06/2017 Abbott Laboratories, Inc
2017-9397 11/06/2017 AUROBINDO PHARMA USA INC
2017-9398 11/06/2017 FOIA GROUP INC
2017-9399 11/06/2017 FOIA GROUP INC
2017-9400 11/06/2017 FOIA GROUP INC
2017-9401 11/06/2017 Brian McBride
2017-9402 11/06/2017 GLOBAL PROTECTION CORP
2017-9404 11/06/2017 BMO HARRIS BANK N.A.
2017-9405 11/06/2017 FDA 510K CONSULTANTS LLC
2017-9406 11/06/2017 ANAPOLWEISS
2017-9407 11/06/2017 ANAPOLWEISS

2017-9408 11/06/2017 AMARIN PHARMA INC
2017-9409 11/06/2017 BARTEE X04771, DUANE L
2017-9410 11/06/2017 LEVIN, PAPANTONIO, THOMAS ET AL
2017-9411 11/06/2017 PBS NEWSHOUR

2017-9412 11/06/2017 OHIO ENVIRONMENTAL COUNCIL
2017-9413 11/06/2017 HUEGLI FRASER PC
2017-9414 11/06/2017 Arnold and Porter Kaye Scholer
2017-9415 11/06/2017 Pinsent Masons LLP

2017-9416 11/06/2017 Modern Healthcare
2017-9418 11/06/2017 ANDREW M PARISH PA

2017-9420 11/07/2017 Lauree Valverde
2017-9421 11/07/2017 Sutro Biopharma
2017-9422 11/07/2017 Sutro Biopharma

2017-9424 11/07/2017 Sutro Biopharma
2017-9425 11/07/2017 Sutro Biopharma

2017-9429 11/07/2017 Leger & Shaw
2017-9431 11/07/2017 Leger & Shaw

2017-9434 11/07/2017 C.H. Robinson Worldwide, Inc.
2017-9437 11/07/2017 ASHES NONPROFIT

2017-9438 11/07/2017 Stevens Institute of Technology
2017-9439 11/07/2017 Shehadeh Giannamore, PLLC
2017-9440 11/07/2017 Almirall, S.A.
2017-9441 11/07/2017 PATARA PHARMACEUTICALS
2017-9442 11/07/2017 DCM
2017-9445 11/07/2017 PHARM3R
2017-9446 11/07/2017 MUCKROCK NEWS

2017-9447 11/07/2017 CNN
2017-9448 11/08/2017 Quinn McCord
2017-9449 11/08/2017 LIFE EXTENSION

2017-9451 11/08/2017 PROPUBLICA
2017-9452 11/08/2017 MARTIN CLEARWATER & BELL
2017-9453 11/08/2017 Michael Kolb

2017-9455 11/08/2017 Doe J
2017-9456 11/08/2017 Case Linden PC

2017-9457 11/08/2017 FDAZILLA
2017-9459 11/08/2017 Dr Ajay Phadke

2017-9460 11/08/2017 Joshua Skeggs
2017-9462 11/08/2017 NUTRA SOURCE
2017-9463 11/08/2017 EndoChoice
2017-9464 11/08/2017 OCONNOR 199579, NYKA
2017-9465 11/08/2017 TRACEY & FOX
2017-9466 11/08/2017 Doe J
2017-9468 11/08/2017 FARMER, DONNIE

2017-9474 11/09/2017 Tobacco Control Legal Consortium
2017-9475 11/09/2017 Crowell & Moring LLP

2017-9476 11/09/2017 UNIVERSITY OF ILLINOIS AT CHICAGO
2017-9477 11/09/2017 KM PHARMACEUTICAL CONSULTING LLC

2017-9478 11/09/2017 Finkelstein & Krins LLP
2017-9479 11/09/2017 Pierre-Olivier Zappa
2017-9481 11/09/2017 Darcy Gilson

2017-9482 11/09/2017 Huvepharma, Inc.
2017-9483 11/09/2017 Kathryn Dobson


2017-9492 11/09/2017 STEPTOE & JOHNSON
2017-9496 11/09/2017 FOI Services, Inc.
2017-9497 11/09/2017 Prateek Goyal
2017-9498 11/09/2017 BresoTEC Inc.
2017-9499 11/09/2017 FDA NEWS

2017-9500 11/09/2017 Leerink Partners, LLC
2017-9501 11/09/2017 AuroMedics Pharma LLC
2017-9503 11/09/2017 Registrar Corp
2017-9504 11/09/2017 Abbott Molecular, Inc.

2017-9505 11/09/2017 Registrar Corp
2017-9506 11/09/2017 Registrar Corp
2017-9507 11/09/2017 Registrar Corp
2017-9508 11/09/2017 LAGANA 346-048, JOEEPH

2017-9509 11/09/2017 BRACCO DIAGNOSTICS INC
2017-9510 11/09/2017 Brutus, Gesuclais
2017-9511 11/09/2017 STAT NEWS

2017-9512 11/09/2017 MITCHELL WILLIAMS
2017-9514 11/13/2017 STAT

2017-9515 11/13/2017 Center for Environmental Health
2017-9519 11/13/2017 Jonathan Sedgh, Weitz & Luxenberg, P.C.
2017-9520 11/13/2017 Donald Ecklund
2017-9521 11/13/2017 David Greenstein

2017-9522 11/13/2017 POMERANTZ LLP
2017-9523 11/13/2017 FMD K&L Inc
2017-9524 11/13/2017 Datavant
2017-9525 11/13/2017 Datavant
2017-9526 11/13/2017 Datavant
2017-9527 11/13/2017 Datavant
2017-9528 11/13/2017 Datavant
2017-9529 11/13/2017 Datavant
2017-9530 11/13/2017 Datavant
2017-9531 11/13/2017 Datavant
2017-9532 11/13/2017 Datavant
2017-9533 11/13/2017 Datavant
2017-9534 11/13/2017 Renata Sklodowska
2017-9535 11/13/2017 PROCTER & GAMBLE
2017-9536 11/13/2017 Manzoor Law Firm, Inc

2017-9537 11/13/2017 Dolat Capital Market Limited
2017-9538 11/13/2017 Management Solutions Experts
2017-9540 11/13/2017 FOIA GROUP INC

2017-9542 11/13/2017 Rockfield Medical Devices
2017-9543 11/13/2017 BLOOMBERG NEWS
2017-9544 11/13/2017 FOIA GROUP INC
2017-9545 11/13/2017 ICU Medical, Inc.

2017-9546 11/13/2017 Eli Lilly and Company
2017-9547 11/13/2017 NinePoint Medical, Inc.
2017-9548 11/13/2017 DEFIBTECH LLC
2017-9549 11/13/2017 Elite Laboratories, Inc.
2017-9550 11/13/2017 Doe J
2017-9551 11/13/2017 Masimo Corporation
2017-9552 11/13/2017 BLOOMBERG NEWS

2017-9553 11/13/2017 UNIVERSITY OF SOUTHERN CALIFORNIA
2017-9554 11/13/2017 PARKER WAICHMAN LLP
2017-9555 11/13/2017 Doe J
2017-9556 11/13/2017 Alvogen Group
2017-9557 11/13/2017 TARO PHARMACEUTICAL INDUSTRIES

2017-9558 11/13/2017 Alvogen Group
2017-9559 11/13/2017 Ranee Singleton
2017-9560 11/13/2017 Gearing, Charles M
2017-9562 11/13/2017 FDA NEWS
2017-9563 11/13/2017 FOI Services, Inc.
2017-9569 11/13/2017 FDA NEWS
2017-9570 11/13/2017 FOI Services, Inc.
2017-9576 11/13/2017 FDA NEWS
2017-9577 11/13/2017 FOI Services, Inc.
2017-9583 11/13/2017 FOI Services, Inc.
2017-9587 11/13/2017 FOI Services, Inc.
2017-9591 11/13/2017 FOI Services, Inc.
2017-9594 11/14/2017 Joshua Sharlin
2017-9596 11/14/2017 FDANEWS
2017-9597 11/14/2017 Silver, Michael N

2017-9599 11/14/2017 SOYFOODS ASSOCIATION OF NORTH AMERICA
2017-9600 11/14/2017 TARO PHARMACEUTICAL INDUSTRIES

2017-9601 11/14/2017 Ardent Mills - Tom Black
2017-9602 11/14/2017 Eurofins
2017-9604 11/14/2017 Ark Surgical Ltd.
2017-9605 11/14/2017 Sojournix Inc.
2017-9606 11/14/2017 Charles Democko
2017-9608 11/14/2017 FDAZILLA
2017-9609 11/14/2017 PharmaTech LLC

2017-9612 11/14/2017 Lumenis Ltd.
2017-9614 11/14/2017 BUCHANAN INGERSOLL & ROONEY PC
2017-9615 11/14/2017 Wiedner & McAuliffe, Ltd.

2017-9616 11/14/2017 PFIZER
COLUMBIA UNIVERSITY MAILMAN SCHOOL OF PUBLIC
2017-9617 11/14/2017 HEALTH
2017-9618 11/14/2017 Cheryl Bianchi
2017-9620 11/14/2017 PIPER JAFFRAY & CO
2017-9621 11/14/2017 Ressler & Tesh, PLLC
2017-9622 11/14/2017 VTM Technologies Ltd.
2017-9624 11/14/2017 FOIA GROUP INC
2017-9625 11/14/2017 Lacey Chessor
2017-9626 11/14/2017 FOIA GROUP INC
2017-9627 11/14/2017 TissueGene, Inc.

2017-9628 11/14/2017 VITROLIFE SWEDEN AB
2017-9629 11/14/2017 FOI Services, Inc.
2017-9630 11/14/2017 Medicure Inc.
2017-9631 11/14/2017 Medicure Inc.
2017-9632 11/14/2017 Takeda Pharmaceuticals International Co.
2017-9633 11/14/2017 KEYSTONE INDUSTRIES
2017-9634 11/14/2017 FOIA GROUP INC
2017-9635 11/14/2017 FOIA GROUP INC
2017-9636 11/14/2017 FOIA GROUP INC
2017-9637 11/14/2017 FOIA GROUP INC
2017-9638 11/14/2017 FOIA GROUP INC
2017-9640 11/14/2017 FOIA GROUP INC
2017-9641 11/14/2017 WATSON, NAOMI
2017-9642 11/14/2017 FELDMAN SHEPHERD ET AL

2017-9643 11/14/2017 DANIEL R MORDARSKI LLC
2017-9644 11/14/2017 Lieff Cabraser Heimann & Bernstein, LLP


2017-9648 11/14/2017 POMERANTZ LLP
2017-9649 11/14/2017 VENABLE LLP
2017-9650 11/14/2017 Doe J
2017-9651 11/15/2017 Porzio Bromberg & Newman, P.C.

2017-9652 11/15/2017 ARKRAY, Inc.
2017-9653 11/15/2017 FOI Services, Inc.
2017-9654 11/15/2017 Law Offices of Lawrence S. Paikoff, M.D., J.D.
2017-9655 11/15/2017 FOI Services, Inc.

2017-9656 11/15/2017 COMPASSION OVER KILLING
2017-9657 11/15/2017 FDANEWS
2017-9658 11/15/2017 FOI Services, Inc.

2017-9660 11/15/2017 The Weston Firm
2017-9661 11/15/2017 FOI Services, Inc.

2017-9662 11/15/2017 FOI Services, Inc.
2017-9663 11/15/2017 Cornerstone Research & Development, Inc
2017-9664 11/15/2017 Ric Barline
2017-9665 11/15/2017 Siddhartha Bhattacharya
2017-9666 11/15/2017 MicroTech Medical
2017-9667 11/15/2017 Zhejiang Huahai Pharmaceutical Co.,Ltd.
2017-9668 11/15/2017 NBC News

2017-9670 11/15/2017 W.L. GORE AND ASSOCIATES GMBH PUTZBRUNN

2017-9671 11/15/2017 Ric Barline
2017-9672 11/15/2017 Ceutical Laboratories, Inc.
2017-9673 11/15/2017 Xeris Pharmaceuticals, Inc.
2017-9674 11/15/2017 Aztach medical device, Inc
2017-9675 11/15/2017 The University of Texas at Tyler

2017-9676 11/15/2017 Hyman, Phelps & McNamara, P.C.
2017-9680 11/15/2017 HAYNES AND BOONE, LLP
2017-9681 11/15/2017 STAT
2017-9683 11/15/2017 STAT
2017-9684 11/16/2017 CLEMSON UNIVERSITY

2017-9685 11/16/2017 FDAAWARE
2017-9686 11/16/2017 U.S. Right to Know

2017-9687 11/16/2017 Labyrinth Devices, LLC
2017-9688 11/16/2017 Law Offices of Joel L. Herz
2017-9689 11/16/2017 Predictive Biotech, Inc.
2017-9690 11/16/2017 HBC INTERNATIONAL, LLC

2017-9693 11/16/2017 Swanson Gardner Meyers PLLC

2017-9694 11/16/2017 Maaz Meah
2017-9695 11/16/2017 Leventhal & Puga, P.C.
2017-9696 11/16/2017 george taub Products & Fusion Co. Inc.
2017-9700 11/16/2017 Cosmedent, Inc.
2017-9701 11/16/2017 STRYKER ENDOSCOPY
2017-9702 11/16/2017 Longwell and Associates
2017-9703 11/16/2017 Dr Ajay Phadke
2017-9704 11/16/2017 FDAZILLA
2017-9705 11/16/2017 Taft, Stettinius & Hollister, LLP
2017-9706 11/16/2017 Copyright Clearance Center

2017-9707 11/16/2017 Pennock Law Firm
2017-9708 11/16/2017 ANIMAL LEGAL DEFENSE FUND

2017-9709 11/16/2017 ICU Medical, Inc.
2017-9710 11/16/2017 ICU Medical, Inc.

2017-9712 11/16/2017 BAIRD LIGHTNER ET AL
2017-9713 11/16/2017 Aspire Bariatrics, Inc

2017-9714 11/16/2017 Doe J
2017-9715 11/16/2017 Juwan Rodriguez
2017-9716 11/16/2017 FOI Services, Inc.
2017-9717 11/16/2017 WALKUP MELODIA ET AL
2017-9718 11/16/2017 MUCKROCK NEWS
2017-9719 11/16/2017 MUCKROCK NEWS
2017-9720 11/16/2017 Predictive Biotech, Inc.
2017-9723 11/16/2017 FORBES MAGAZINE
2017-9724 11/16/2017 LIGHTFOOT FRANKLIN & WHITE LLC

2017-9725 11/16/2017 ANDREW M PARISH PA
2017-9726 11/16/2017 CHILLEMI, TESSA

2017-9728 11/17/2017 MCGILL UNIVERSITY
2017-9729 11/17/2017 Glancy Prongay & Murray LLP
2017-9730 11/17/2017 University of Applied Sciences and Arts
2017-9731 11/17/2017 FORBES
2017-9732 11/17/2017 Michigan Milk Producers Association

2017-9733 11/17/2017 FOI Services, Inc.
2017-9734 11/17/2017 FDAZILLA

2017-9736 11/17/2017 HCRP
2017-9737 11/17/2017 Mott Haven Herald

2017-9739 11/17/2017 Wiedner & McAuliffe, Ltd.

2017-9740 11/17/2017 FOI Services, Inc.
2017-9741 11/17/2017 FOI Services, Inc.
2017-9742 11/17/2017 SMITH & NEPHEW
2017-9743 11/17/2017 TFH Publications, Inc

2017-9745 11/17/2017 FDAZILLA
2017-9746 11/17/2017 Clinical & Regulatory Solutions
2017-9747 11/17/2017 Curaline Inc
2017-9748 11/17/2017 MRC-X, LLC
2017-9749 11/17/2017 CHARTWELL RX SCIENCES LLC
2017-9750 11/17/2017 FRITZ GOLDENBERG & BIANCULLI LLC

2017-9751 11/17/2017 DCCC
2017-9752 11/17/2017 Perantinides & Nolan Co., L.P.A.
2017-9753 11/17/2017 PARHAM SMITH & ARCHENHOLD LLC

2017-9754 11/17/2017 Wilson, Sonsini, Goodrich & Rosati
2017-9755 11/17/2017 PYREXAR MEDICAL INC
2017-9756 11/17/2017 MUCKROCK NEWS
2017-9757 11/20/2017 Otto bock healthcare LP

2017-9758 11/20/2017 Scott Lindberg
2017-9759 11/20/2017 ICU Medical, Inc.

2017-9760 11/20/2017 Quanta Dialysis Technologies
2017-9761 11/20/2017 FOI Services, Inc.

2017-9762 11/20/2017 Susan Thixton/Association for Truth in Pet Food
2017-9763 11/20/2017 Teleflex Incorporated
2017-9764 11/20/2017 Teleflex Inc.
Yale Collaboration for Research Integrity &
Transparency and the Center for Medicine and
2017-9765 11/20/2017 Media at the Dartmouth Institute
2017-9766 11/20/2017 HuffPost

2017-9767 11/20/2017 AZTACH medical device inc
2017-9768 11/20/2017 The Adirondack Daily Enterprise

2017-9771 11/20/2017 Peter Spaulding

2017-9772 11/20/2017 P.C.
2017-9773 11/20/2017 LuTran Inc.

2017-9775 11/20/2017 The Spence Law Firm, LLC

2017-9776 11/20/2017 MEDTRONIC
2017-9777 11/20/2017 Intertek USA, Inc.
2017-9778 11/20/2017 ICU Medical, Inc.

2017-9779 11/20/2017 MOTLEY RICE LLC
2017-9780 11/20/2017 ICU Medical, Inc.

2017-9782 11/20/2017 ICU Medical, Inc.

2017-9784 11/20/2017 Panjin Hetian Food Co., Ltd

2017-9785 11/20/2017 Biological E. Limited
2017-9786 11/20/2017 Association for the Safe Use of Ecbolic
2017-9787 11/20/2017 LIFE EXTENSION
2017-9788 11/20/2017 York Capital

2017-9790 11/20/2017 Dr Ajay Phadke
2017-9791 11/20/2017 Octapharma Plasma Inc

2017-9793 11/20/2017 Compass Health Brands Corp.
2017-9794 11/20/2017 BOSTON MEDICAL CENTER
2017-9795 11/20/2017 AMERICAN BRIDGE 21ST CENTURY
2017-9796 11/20/2017 GREENBERG TRAURIG LLP
2017-9798 11/20/2017 TNT MOBORG INTERNATIONAL LTD

2017-9800 11/20/2017 Fresenius Medical Care North America
2017-9803 11/20/2017 PURDUE PHARMA LP
2017-9804 11/20/2017 Morgan, Lewis & Bockius LLP
2017-9805 11/21/2017 FDA NEWS
2017-9806 11/21/2017 FDA NEWS
2017-9807 11/21/2017 FDA NEWS
2017-9808 11/21/2017 FDANEWS
2017-9809 11/21/2017 FDANEWS
2017-9810 11/21/2017 FDANEWS
2017-9811 11/21/2017 FDA NEWS
2017-9812 11/21/2017 FDA NEWS
2017-9813 11/21/2017 FDANEWS

2017-9814 11/21/2017 FDANEWS
2017-9816 11/21/2017 FDANEWS
2017-9818 11/21/2017 FDA NEWS


Story of Stuff Project, Courage Campaign
2017-9822 11/21/2017 Institute
2017-9823 11/21/2017 FDA NEWS

2017-9825 11/21/2017 ndp analytics
2017-9826 11/21/2017 Montgomery Advertiser
2017-9827 11/21/2017 FDANEWS
2017-9829 11/21/2017 FDANEWS

2017-9831 11/21/2017 FDANEWS
2017-9832 11/21/2017 FDA NEWS
2017-9833 11/21/2017 FDA NEWS
2017-9834 11/21/2017 THOMSON REUTERS
2017-9835 11/21/2017 FDANEWS

2017-9837 11/21/2017 FOI Services, Inc.
2017-9838 11/21/2017 FOI Services, Inc.
2017-9840 11/21/2017 PROPUBLICA
2017-9841 11/21/2017 BOSTON SCIENTIFIC CORPORATION
2017-9843 11/21/2017 Amanda Dykeman
2017-9844 11/21/2017 barbara kurys
2017-9846 11/21/2017 ORBIMED ADVISORS LLC
2017-9847 11/21/2017 Organogenesis Inc.
2017-9848 11/21/2017 Grupo Biotoscana



2017-9853 11/21/2017 FINNEGAN HENDERSON ET AL
2017-9854 11/21/2017 WHARTON SCHOOL, UNIVERSITY OF PENNSYLVANIA
2017-9855 11/21/2017 Leventhal & Puga, P.C.
2017-9857 11/21/2017 LOEB & LOEB LLP
2017-9858 11/21/2017 LOEB & LOEB LLP

2017-9859 11/21/2017 ANAPOLWEISS
2017-9860 11/21/2017 FORBES MAGAZINE

2017-9861 11/21/2017 LINDER #25913-048, DAVID WILLIAM
2017-9862 11/22/2017 Dr Ajay Phadke
2017-9864 11/22/2017 HealthMyne, Inc.
2017-9865 11/22/2017 Thomas Cavanagh
2017-9866 11/22/2017 Zimmer Biomet

2017-9867 11/22/2017 FDA NEWS
2017-9868 11/22/2017 FDA NEWS
2017-9869 11/22/2017 FDA NEWS
2017-9870 11/22/2017 FDA NEWS
2017-9871 11/22/2017 FDA NEWS
2017-9872 11/22/2017 FDA NEWS
2017-9873 11/22/2017 FDA NEWS
2017-9874 11/22/2017 FDA NEWS
2017-9875 11/22/2017 FDA NEWS
2017-9876 11/22/2017 FDA NEWS
2017-9877 11/22/2017 Law Office of Nick R. Masino
2017-9878 11/22/2017 MEDTRONIC MINIMED
2017-9879 11/22/2017 Ace Endico
2017-9880 11/22/2017 AndersonBrecon Inc.

2017-9881 11/22/2017 Sysmex America, Inc.
2017-9884 11/22/2017 Pennock Law Firm
2017-9885 11/22/2017 Pennock Law Firm

2017-9887 11/22/2017 FDA NEWS
2017-9888 11/22/2017 FDA NEWS
2017-9889 11/22/2017 FDA NEWS
2017-9890 11/22/2017 FDA NEWS
2017-9891 11/22/2017 FDA NEWS
2017-9892 11/22/2017 FDA NEWS
2017-9893 11/22/2017 FDA NEWS
2017-9894 11/22/2017 FDA NEWS

2017-9895 11/22/2017 Shirley Ryan AbilityLab
2017-9896 11/22/2017 The Turning Point
2017-9898 11/22/2017 MERCK & CO., INC.
2017-9899 11/22/2017 MERCK & CO., INC.
2017-9900 11/22/2017 MERCK & CO., INC.
2017-9901 11/22/2017 MERCK & CO., INC.
2017-9902 11/22/2017 MERCK & CO., INC.
2017-9903 11/22/2017 MERCK & CO., INC.
2017-9904 11/22/2017 MERCK & CO., INC.
2017-9905 11/22/2017 MERCK & CO., INC.
2017-9906 11/22/2017 MERCK & CO., INC.
2017-9907 11/22/2017 MERCK & CO., INC.
2017-9908 11/22/2017 MERCK & CO., INC.
2017-9909 11/22/2017 MERCK & CO., INC.
2017-9910 11/22/2017 MERCK & CO., INC.
2017-9911 11/22/2017 MERCK & CO., INC.
2017-9912 11/22/2017 MERCK & CO., INC.
2017-9913 11/22/2017 MERCK & CO., INC.
2017-9914 11/22/2017 MERCK & CO., INC.
2017-9915 11/22/2017 MERCK & CO., INC.
2017-9916 11/22/2017 MERCK & CO., INC.
2017-9917 11/22/2017 MERCK & CO., INC.
2017-9918 11/22/2017 MERCK & CO., INC.
2017-9919 11/22/2017 MERCK & CO., INC.
2017-9920 11/22/2017 MERCK & CO., INC.
2017-9921 11/22/2017 MERCK & CO., INC.
2017-9922 11/22/2017 MERCK & CO., INC.
2017-9923 11/22/2017 MERCK & CO., INC.
2017-9924 11/22/2017 MERCK & CO., INC.
2017-9931 11/24/2017 Knowles Law Firm, PC

2017-9932 11/24/2017 FOI Services, Inc.
2017-9935 11/24/2017 University hospital Cologne, Germany
2017-9936 11/24/2017 Daniel Samuels
2017-9937 11/24/2017 SCIEGEN PHARMACEUTICALS INC

2017-9938 11/24/2017 Kratom United
2017-9939 11/24/2017 David Lortscher MD Inc

2017-9942 11/24/2017 Datavant
2017-9943 11/24/2017 Datavant
2017-9944 11/24/2017 Datavant
2017-9945 11/24/2017 Datavant
2017-9946 11/24/2017 Datavant
2017-9947 11/24/2017 Datavant
2017-9948 11/24/2017 Datavant
2017-9949 11/24/2017 Datavant
2017-9950 11/24/2017 Datavant
2017-9951 11/24/2017 Datavant
2017-9952 11/24/2017 FOI Services, Inc.
2017-9953 11/27/2017 CLARIANT PRODUKTE (DEUTSCHLAND) GMBH

2017-9954 11/27/2017 KEYS 22458017, CLAY
2017-9955 11/27/2017 PYREXAR MEDICAL INC
2017-9956 11/27/2017 PALMER LAW FIRM PA

2017-9957 11/27/2017 Doe J
2017-9958 11/27/2017 FOI Services, Inc.
2017-9959 11/27/2017 Bienert, Miller & Katzman, PLC
2017-9961 11/27/2017 ANAPOLWEISS

2017-9963 11/27/2017 AprioMed AB

2017-9964 11/27/2017 PFIZER INC.
2017-9965 11/27/2017 FOLEY HOAG LLP
2017-9966 11/27/2017 Jay Chand

2017-9971 11/27/2017 Dr. Reddy's Laboratories, Inc.
2017-9973 11/27/2017 ITG BRANDS
2017-9975 11/27/2017 GONZALEZ, RICK

2017-9977 11/27/2017 UNIGEN

2017-9981 11/27/2017 NAKANISHI INC.
2017-9982 11/27/2017 Saptalis Pharmaceuticals LLC
2017-9987 11/27/2017 OFW LAW

2017-9988 11/27/2017 Intoromedic Co., Ltd

2017-9990 11/27/2017 Clinical & Regulatory Solutions
2017-9993 11/27/2017 Orsenix LLC
2017-9994 11/27/2017 FDAZILLA
2017-9995 11/27/2017 THE PINK SHEET

2017-9996 11/27/2017 UNIGEN
2017-9997 11/27/2017 Dr Ajay Phadke

2017-9998 11/27/2017 UNIGEN
2018-1 01/02/2018 Allergic Living
2018-10 01/02/2018 Montague, Pittman & Varnado
2018-100 01/03/2018 ANAPOLWEISS
2018-1001 02/06/2018 Beveridige & Diamond, PC
2018-1004 02/07/2018 FDAZILLA

2018-1005 02/07/2018 Registrar Corp
2018-1007 02/07/2018 FOI Services, Inc.
2018-1008 02/07/2018 James Alexander Coorperation
2018-1009 02/07/2018 MAVERICK CAPITAL
2018-101 01/03/2018 WEEKLEY SCHULTE ET AL

2018-1013 02/07/2018 FDAZILLA

2018-1014 02/07/2018 United States Endoscopy Group, Inc.
2018-1015 02/07/2018 THE DEGGE GROUP, LTD.
2018-1016 02/07/2018 Registrar Corp
2018-1017 02/07/2018 Registrar Corp
2018-1018 02/07/2018 Registrar Corp
2018-1019 02/07/2018 Philippe Cornet

2018-102 01/03/2018 DCCC
2018-1020 02/07/2018 TN Dept of Health Office of Investigations
2018-1021 02/07/2018 Cole-Frieman & Mallon LLP

2018-1023 02/07/2018 Akerman LLP
2018-1024 02/07/2018 Akerman LLP
2018-1025 02/07/2018 Edenbridge Pharmaceuticals LLC

2018-1026 02/07/2018 johnson, craig

2018-1028 02/07/2018 Registrar Corp
2018-1029 02/07/2018 Kozonis Law, Ltd.

2018-103 01/03/2018 GREENSPOON MARDER PA
2018-1030 02/07/2018 Registrar Corp
2018-1033 02/07/2018 Bloomberg News

2018-1034 02/07/2018 Cipla USA, Inc.

2018-1039 02/08/2018 Alpine Alternative Healing Company LLC
2018-104 01/03/2018 TATE-EL-BEY-TEY-WASH, MARCUS
2018-1040 02/08/2018 FDAZILLA
2018-1041 02/08/2018 FDAZILLA
2018-1042 02/08/2018 FDAZILLA
2018-1043 02/08/2018 FDAZILLA
2018-1044 02/08/2018 STAT
2018-1045 02/08/2018 FDAZILLA
2018-1046 02/08/2018 FDAZILLA
2018-1048 02/08/2018 Michael Wolf
2018-1049 02/08/2018 FDAZILLA

2018-105 01/03/2018 KEYS 22458017, CLAY
2018-1050 02/08/2018 FDAZILLA
2018-1051 02/08/2018 FDAZILLA

2018-1052 02/08/2018 FDAZILLA
2018-1053 02/08/2018 FDAZILLA

2018-1054 02/08/2018 WILEY REIN LLP
2018-1056 02/08/2018 SANOFI

2018-1058 02/08/2018 Raley's
2018-1059 02/08/2018 Morgan Stanley
2018-106 01/04/2018 Physio-Logic Ltd.
2018-1060 02/08/2018 NBC NEWS

2018-1061 02/09/2018 FOI Services, Inc.
2018-1062 02/09/2018 FOI Services, Inc.
2018-1064 02/09/2018 THOMSON REUTERS
2018-1065 02/09/2018 BRIDGER CAPITAL LLC

2018-1066 02/09/2018 HealthCare Royalty Partners
2018-1067 02/09/2018 Prateek Goyal
2018-1068 02/09/2018 Prateek Goyal

2018-1069 02/09/2018 FOI Services, Inc.
2018-107 01/04/2018 Richard Fields

2018-1070 02/09/2018 Marshall Dennehey Warner Coleman & Goggin
2018-1071 02/09/2018 Kleinfeld, Kaplan & Becker LLP
2018-1072 02/09/2018 PL DEVELOPMENTS
2018-1073 02/09/2018 MCGILL UNIVERSITY

2018-1076 02/09/2018 Joe Griffin

2018-1077 02/09/2018 elliquence llc
2018-108 01/04/2018 Zipin, Amster & Greenberg, LLC
2018-1080 02/12/2018 Carestream Health Inc.

2018-1081 02/12/2018 FDAZILLA
2018-1083 02/12/2018 ALK-Abello, Inc.
2018-1084 02/12/2018 MEDTRONIC
2018-1085 02/12/2018 Wiley Rein, LLP

2018-1086 02/12/2018 Frank Sparks
2018-1087 02/12/2018 POA Pharma Scandinavia AB
2018-1088 02/12/2018 FDAAWARE
2018-1089 02/12/2018 Dynavax Technologies Corporation
2018-109 01/04/2018 Physio-Logic Ltd.
2018-1090 02/12/2018 Dynavax Technologies Corporation
2018-1091 02/12/2018 April Mensik

2018-1092 02/12/2018 FDA NEWS
2018-1093 02/12/2018 FDA NEWS
2018-1094 02/12/2018 FDA NEWS
2018-1095 02/12/2018 FDA NEWS
2018-1096 02/12/2018 FDA NEWS
2018-1097 02/12/2018 FDA NEWS
2018-1098 02/12/2018 FDA NEWS
2018-1099 02/12/2018 FDA NEWS
2018-11 01/02/2018 Brenner, Monroe, Scott & Anderson, Ltd
2018-110 01/04/2018 ANKON Technologies Co., Ltd.
2018-1100 02/12/2018 FDA NEWS
2018-1101 02/12/2018 FDA NEWS
2018-1102 02/12/2018 FDA NEWS
2018-1103 02/12/2018 FDA NEWS
2018-1104 02/12/2018 FDA NEWS
2018-1105 02/12/2018 FDA NEWS
2018-1106 02/12/2018 FDA NEWS
2018-1107 02/12/2018 FDA NEWS
2018-1108 02/12/2018 FDA NEWS
2018-1109 02/12/2018 FDA NEWS
2018-1110 02/12/2018 FDA NEWS
2018-1111 02/12/2018 Hill Country Bakery LLC

2018-1112 02/12/2018 FDA NEWS
2018-1113 02/12/2018 FDA NEWS
2018-1114 02/12/2018 STAT

2018-1115 02/12/2018 FDAAWARE
2018-1116 02/12/2018 FDAAWARE
2018-1117 02/12/2018 COGENCY GLOBAL INC.
2018-1118 02/12/2018 LIPPES MATHIAS WEXLER FRIEDMAN LLP

2018-1119 02/12/2018 FDAAWARE
2018-112 01/04/2018 Registrar Corp

2018-1120 02/12/2018 Monocl Strategy Services AB
2018-1121 02/12/2018 K&L Gates LLP
2018-1122 02/12/2018 UNIV OF MINNESOTA CARLSON SCHOOL OF MANAGEMENT

2018-1123 02/12/2018 VAVE HEALTH INC
2018-1124 02/12/2018 BLOOMBERG NEWS
2018-1125 02/12/2018 BLOOMBERG NEWS

2018-1126 02/12/2018 MUCKROCK NEWS
2018-1127 02/12/2018 MUCKROCK NEWS

2018-1128 02/12/2018 NAPIER GAULT SCHUPBACH & STEVENS PLC
2018-1129 02/12/2018 Akerman LLP

2018-113 01/04/2018 Quality & Regulatory Associates, LLC
2018-1130 02/12/2018 PROFICIENTRX
2018-1131 02/13/2018 HuffPost

2018-1132 02/13/2018 FOI Services, Inc.
2018-1133 02/13/2018 FOI Services, Inc.
2018-1134 02/13/2018 P.C.
2018-1136 02/13/2018 BLOOMBERG NEWS
2018-1137 02/13/2018 FOI Services, Inc.
2018-1138 02/13/2018 FOI Services, Inc.
2018-1139 02/13/2018 Noven Pharmaceuticals, Inc.
2018-114 01/04/2018 Ted Owen

2018-1141 02/13/2018 Amicus Therapeutics, Inc.
2018-1142 02/13/2018 FOI Services, Inc.
2018-1143 02/13/2018 FDAZILLA

2018-1144 02/13/2018 SleepMed Inc.
2018-1145 02/13/2018 WILEY REIN LLP
2018-1147 02/13/2018 NEBA Health, LLC
2018-1148 02/13/2018 Chiasma Inc

2018-1149 02/14/2018 Arkema Inc (Formerly Atofina Chemicals)
2018-115 01/04/2018 Nova Tech EEG
2018-1150 02/14/2018 PCCA

2018-1152 02/14/2018 BLOOMBERG NEWS
2018-1153 02/14/2018 FOIA GROUP INC
2018-1154 02/14/2018 Brett Howard
2018-1155 02/14/2018 Watkins, Lourie, Roll & Chance, PC

2018-1156 02/14/2018 Prasco LLC
2018-1157 02/14/2018 BONWRx Ltd

2018-1158 02/14/2018 UCLA Neurosurgery
2018-1159 02/14/2018 Doe J
2018-116 01/04/2018 Aylstock, Witkin, Kreis & Overholtz, PLLC

2018-1160 02/14/2018 Medefil, Inc
2018-1161 02/14/2018 WTLV
2018-1162 02/14/2018 CONSUMER REPORTS
2018-1163 02/14/2018 Biondillo's Baking Company LLC

2018-1164 02/14/2018 WTLV
2018-1165 02/14/2018 United Therapeutics Corporation
2018-1166 02/14/2018 LWGAT.BLOGSPOT.COM
2018-1167 02/14/2018 LWGAT.BLOGSPOT.COM

2018-1168 02/14/2018 HILL-ROM
2018-1169 02/14/2018 Wright Schimmel, LLC

2018-117 01/04/2018 Physio-Logic Ltd.
2018-1170 02/14/2018 MEDTRONIC
2018-1171 02/14/2018 PENTAX MEDICAL CO
2018-1172 02/14/2018 FOIA GROUP INC
2018-1173 02/14/2018 Vista IP Law Group LLP
2018-1174 02/14/2018 FOIA GROUP INC
2018-1175 02/14/2018 FOIA GROUP INC
2018-1176 02/14/2018 BANNICK CONSULTING LLC
2018-1177 02/14/2018 FOIA GROUP INC
2018-1178 02/14/2018 FOIA GROUP INC
2018-1179 02/14/2018 CROWELL & MORING

2018-118 01/04/2018 Dr. Laurie Coger
2018-1180 02/14/2018 Reekers, Meredith
2018-1181 02/14/2018 SYNTHODEON
2018-1182 02/14/2018 UNIGEN
2018-1183 02/14/2018 NOVARTIS
2018-1184 02/14/2018 DCCC
2018-1185 02/14/2018 Tampa Bay Times
2018-1188 02/14/2018 GRAYBUG VISION

2018-1189 02/14/2018 DCCC
2018-1190 02/14/2018 BRIAN R WILSON LLC
2018-1191 02/14/2018 BLANK ROME ET AL

2018-1192 02/14/2018 DCCC
2018-1194 02/14/2018 PERMANENTE MEDICAL GROUP INC
2018-1195 02/14/2018 ABC FARMACEUTICI
2018-1196 02/15/2018 FDAZILLA
2018-1197 02/15/2018 FOLEY, BARON, METZGER & JUIP,P
2018-1198 02/15/2018 TONIC WORLD CENTER S.A. DE C.V.

2018-120 01/04/2018 EDWARDS, A
2018-1201 02/15/2018 FDAZILLA
2018-1202 02/15/2018 FDAZILLA
2018-1203 02/15/2018 Richard Lipov

2018-1204 02/15/2018 Doe J
2018-1205 02/15/2018 FOIA GROUP INC
2018-1206 02/15/2018 The Snapka Law Firm

2018-1207 02/15/2018 BLOOMBERG NEWS
2018-1209 02/15/2018 Martin, Sheryl
2018-121 01/04/2018 Biolase, Inc
2018-1210 02/15/2018 Elizabeth Carney DVM
2018-1211 02/15/2018 Alex Cox

2018-1213 02/15/2018 FOIA GROUP INC
2018-1214 02/15/2018 FOIA GROUP INC
2018-1215 02/15/2018 FOIA GROUP INC
2018-1216 02/15/2018 NeuroPace, Inc.
2018-1217 02/15/2018 Joe Griffin

2018-1218 02/15/2018 RedLeaf Biologics, Inc.
2018-1219 02/15/2018 NeuroPace, Inc.
2018-122 01/04/2018 Lost Art Liquids, LLC

2018-1220 02/15/2018 United BioSource Corporation
2018-1222 02/15/2018 United BioSource Corporation
2018-1223 02/15/2018 Allergan - Liziel Concepcion
2018-1224 02/15/2018 BraunHagey & Borden
2018-1225 02/15/2018 Steve Lufkin
2018-1227 02/15/2018 RequestArchive
2018-1228 02/15/2018 Pink Sheet/Informa Business Information

2018-123 01/04/2018 Physio-Logic Ltd.

2018-1232 02/15/2018 Wilson Sonsini Goodrich & Rosati
2018-1233 02/15/2018 NBC NEWS
2018-1234 02/15/2018 Dr Ajay Phadke

2018-1239 02/15/2018 FOI Services, Inc.
2018-124 01/04/2018 ManTech International
2018-1240 02/15/2018 FOI Services, Inc.
2018-1241 02/15/2018 FOI Services, Inc.
2018-1242 02/15/2018 FOI Services, Inc.

2018-1250 02/15/2018 FDA NEWS
2018-1251 02/15/2018 FDA NEWS
2018-1252 02/15/2018 FDA NEWS
2018-1253 02/15/2018 FDA NEWS
2018-126 01/04/2018 Burdock Group Consultants
2018-1260 02/16/2018 FOIA GROUP INC
2018-1261 02/16/2018 FOIA GROUP INC
2018-1262 02/16/2018 Robert Blaskiewicz

Bryan Bourgeois, Weimbs,lab, Dept. of MCDB, Univ.
2018-1263 02/16/2018 of California Santa Barbara
2018-1264 02/16/2018 SHIRE
2018-1265 02/16/2018 Phyllis Entis
2018-1266 02/16/2018 JOHNS HOPKINS UNIVERSITY

2018-1267 02/16/2018 law office of alexander b ramey
2018-1268 02/16/2018 FOIA GROUP INC
2018-1269 02/16/2018 FOI Services, Inc.
2018-1270 02/16/2018 FOI Services, Inc.
2018-1271 02/16/2018 FOI Services, Inc.
2018-1272 02/16/2018 FOI Services, Inc.
2018-1273 02/16/2018 FOI Services, Inc.
2018-1274 02/16/2018 FOI Services, Inc.
2018-128 01/04/2018 LIFECORE BIOMEDICAL

2018-129 01/04/2018 Sullivan IP Solutions

2018-1297 02/16/2018 FDA NEWS
2018-1299 02/16/2018 FOIA GROUP INC
2018-13 01/02/2018 KING & SPALDING

2018-1300 02/16/2018 FOIA GROUP INC
2018-1301 02/20/2018 The Weinberg Group Inc.
2018-1302 02/20/2018 FOI Services, Inc.
2018-1303 02/20/2018 Frank Sparks
2018-1304 02/20/2018 FOI Services, Inc.
2018-1305 02/20/2018 FOI Services, Inc.
2018-1306 02/20/2018 Kadmon Pharmaceuticals, LLC
2018-1308 02/20/2018 SHIRE
2018-1309 02/20/2018 Guggenheim Securities, LLC
2018-131 01/04/2018 SonoMotion

2018-1310 02/20/2018 Mark Campbell

2018-1312 02/20/2018 Dr. Reddy's Laboratories, Inc.
2018-1313 02/20/2018 ALM Media

2018-1315 02/20/2018 IntraOp Medical Corporation

2018-1318 02/20/2018 Bard Peripheral Vascular, Inc.

2018-132 01/04/2018 PAREXEL INTERNATIONAL CORP
2018-1323 02/20/2018 FDAAWARE

2018-1324 02/20/2018 Jefferies LLC
2018-1328 02/20/2018 J. Stewart Grad, P.A.

2018-1329 02/20/2018 Thomson Reuters - Clarivate Analytics
2018-133 01/04/2018 Maresco, Anthony

2018-1332 02/20/2018 Advantage medical Electronics

2018-1333 02/20/2018 Prometheus Laboratories Inc.
2018-1334 02/20/2018 Lockton Dunning Benefits

2018-1335 02/20/2018 Medtronic Spine - Lee Grant
2018-1337 02/20/2018 Registrar Corp
2018-1338 02/20/2018 CITADEL LLC
2018-1339 02/20/2018 Bicon, LLC
2018-134 01/04/2018 IPS HEART

2018-1341 02/20/2018 FOI Services, Inc.
2018-1342 02/20/2018 Morgan, Lewis & Bockius LLP

2018-1345 02/20/2018 Cordts Consulting LLC
2018-1346 02/20/2018 CARDINAL HEALTH
2018-1347 02/20/2018 Peter Norton (DeltaTrak USA)
2018-135 01/04/2018 Dolan, Michael F
2018-1351 02/20/2018 FOI Services, Inc.
2018-1352 02/20/2018 Donofrio, Ruth

2018-1353 02/20/2018 IBM
2018-1354 02/20/2018 FOI Services, Inc.
2018-1355 02/20/2018 Pure Source, LLC

2018-1356 02/20/2018 Innocoll Pharmaceuticals
2018-1357 02/21/2018 Dheeresh Pathak
2018-1358 02/21/2018 DEKA R&D
2018-1359 02/21/2018 PFIZER

2018-136 01/04/2018 FOIA GROUP INC
2018-1360 02/21/2018 Chalice Mediacl Limited
2018-1361 02/21/2018 ET Now
2018-1362 02/21/2018 FOI Services, Inc.
2018-1363 02/21/2018 ET Now
2018-1364 02/21/2018 Carissa Rossi
2018-1365 02/21/2018 Kline & Company
2018-1366 02/21/2018 Eurofins

2018-1367 02/21/2018 FDAble LLC
2018-1369 02/21/2018 FDA NEWS
2018-137 01/04/2018 FOIA GROUP INC
2018-1370 02/21/2018 FDA NEWS

2018-1371 02/21/2018 BELISLE-LANGLOIS, JOSIE
2018-1372 02/21/2018 DEKA R&D
2018-1373 02/21/2018 Nanci Koperski
2018-1374 02/21/2018 Roll Law Group P.C.

2018-1375 02/21/2018 Zest Dental Solutions
2018-1376 02/21/2018 Medtronic Spine - Lee Grant
2018-1377 02/21/2018 FDAZILLA
2018-1378 02/21/2018 Asterisk, LLC
2018-1379 02/21/2018 CROWELL & MORING

2018-138 01/04/2018 FDAAWARE
2018-1380 02/21/2018 Dr Ajay Phadke

2018-1381 02/21/2018 Northeastern University
2018-1382 02/21/2018 FDAZILLA
2018-1383 02/21/2018 FOI Services, Inc.
2018-1384 02/21/2018 Millar Inc.
2018-1385 02/21/2018 FOI Services, Inc.

2018-1386 02/21/2018 Millar Inc.
2018-1387 02/21/2018 FOI Services, Inc.
2018-1388 02/21/2018 ICU Medical, Inc.

2018-1389 02/21/2018 FOI Services, Inc.
2018-139 01/04/2018 FDAZILLA
2018-1390 02/21/2018 BLOOMBERG NEWS

2018-1392 02/21/2018 Millar Inc.
2018-1394 02/21/2018 Biologics Consulting Group, Inc.
2018-1395 02/21/2018 AIBMR Life Sciences, Inc.
Kansas State University, College of Veterinary
2018-1396 02/21/2018 Medicine
2018-1397 02/21/2018 The Argen Corporation
2018-1398 02/21/2018 SUSSMAN, MARVIN L
2018-1399 02/21/2018 ANAPOLWEISS
2018-14 01/02/2018 OREGON STATE UNIVERSITY

2018-1400 02/21/2018 NAPIER GAULT SCHUPBACH & STEVENS PLC
2018-1401 02/21/2018 AVRAM BLAIR & ASSOC

2018-1402 02/21/2018 AMHERST COLLEGE
2018-1404 02/21/2018 GORDON & HOLMES

2018-1405 02/21/2018 TEAM LEGAL
2018-1406 02/21/2018 AVRAM BLAIR & ASSOC
2018-1407 02/21/2018 AbbVie US LLC
2018-1408 02/21/2018 AbbVie US LLC
2018-1409 02/21/2018 AbbVie US LLC

2018-1410 02/21/2018 AbbVie US LLC
2018-1411 02/21/2018 INDIANAPOLIS LITIGATION SUPPORT GROUP
2018-1412 02/21/2018 AVILA & SHADDOW
2018-1413 02/21/2018 ALBERT W VAN CLEAVE III, PLLC

2018-1414 02/21/2018 BUFETE OLIVERO BARRETO CSP
2018-1416 02/21/2018 CHEMENCE
2018-1417 02/21/2018 GRAIN PROCESSING CORP
2018-1419 02/21/2018 MUCKROCK NEWS

2018-142 01/05/2018 Registrar Corp
2018-1421 02/21/2018 McCabe Russell, P.A.
2018-1422 02/22/2018 Carl Zeiss Meditec, Inc.
2018-1424 02/22/2018 David Wong
2018-1425 02/22/2018 Rivers Law Firm, LLC

2018-1426 02/22/2018 Apex Medical Technologies, Inc.
2018-1427 02/22/2018 Curbell Medical Products, Inc.
2018-1428 02/22/2018 APCER Life Sciences Inc.

2018-1431 02/22/2018 Doe J
2018-1433 02/22/2018 FOI Services, Inc.
2018-1436 02/22/2018 Tremeau Pharmaceuticals, Inc.
2018-1438 02/22/2018 Northwestern University

2018-144 01/05/2018 Baird
2018-1440 02/22/2018 RAY THOMPSON
2018-1441 02/22/2018 RAY THOMPSON
2018-1442 02/22/2018 RAY THOMPSON

2018-1443 02/22/2018 RAY THOMPSON
2018-1444 02/22/2018 Curbell Medical Products, Inc.
2018-1445 02/22/2018 RAY THOMPSON
2018-1446 02/22/2018 RAY THOMPSON
2018-1447 02/22/2018 RAY THOMPSON
2018-1448 02/22/2018 Tremeau Pharmaceuticals, Inc.

2018-1449 02/22/2018 THOMSON REUTERS
2018-145 01/05/2018 FDAZILLA

2018-1450 02/22/2018 FOI Services, Inc.
2018-1451 02/22/2018 Doe J
2018-1452 02/22/2018 RAY THOMPSON
2018-1453 02/22/2018 RAY THOMPSON
2018-1454 02/22/2018 RAY THOMPSON

2018-1455 02/22/2018 RAY THOMPSON
2018-1456 02/22/2018 RAY THOMPSON
2018-1457 02/22/2018 RAY THOMPSON
2018-1458 02/22/2018 RAY THOMPSON

2018-1459 02/22/2018 Swisher International, Inc.
2018-146 01/05/2018 FDAZILLA
2018-1460 02/22/2018 UNIVERSITY OF BRITISH COLUMBIA

2018-1461 02/22/2018 ET Now
2018-1463 02/22/2018 YALE LAW SCHOOL

2018-1464 02/22/2018 Pinbloggs - Pharmaceutical insight News
2018-1465 02/22/2018 Shanghai SUNGO Management Consulting CO., Ltd.
2018-1468 02/22/2018 GoodResearch

2018-1470 02/22/2018 KOMU 8 NEWS
2018-1473 02/22/2018 PROPERTY OF THE PEOPLE
2018-1474 02/22/2018 Liggett Vector Brands Inc.
2018-1475 02/22/2018 FDA NEWS


2018-1478 02/22/2018 HOGAN LOVELLS LLP
2018-1479 02/22/2018 SANFORD N RICHMAN MD
2018-148 01/05/2018 FDAZILLA

2018-1480 02/22/2018 NUTRA SOURCE
2018-1483 02/22/2018 Riconpharma LLC
2018-1484 02/22/2018 NUTRA SOURCE
2018-1485 02/22/2018 NUTRA SOURCE
2018-1487 02/22/2018 SIDLEY AUSTIN LLP
2018-1489 02/22/2018 COVINGTON BURLING LLP
2018-149 01/05/2018 Dahlquist, Dahlquist L
2018-1490 02/22/2018 COVINGTON BURLING LLP
2018-1491 02/23/2018 Doe J
2018-1492 02/23/2018 BASIC RESEARCH LTD
2018-1493 02/23/2018 ROCKY MOUNTAIN POISON & DRUG CENTER

2018-1494 02/23/2018 SAMSTER KONKEL ET AL
2018-1495 02/23/2018 CONWAY HOMER PC
2018-1496 02/23/2018 EARLY SULLIVAN WRIGHT GIZER & MCRAE LLP

2018-1499 02/23/2018 Cipla Limited
2018-15 01/02/2018 Montague, Pittman & Varnado
2018-150 01/05/2018 Business Insider

2018-1500 02/23/2018 Simergent, LLC
2018-1501 02/23/2018 KETTLE MAGAZINE

2018-1502 02/23/2018 UNIV OF MINNESOTA CARLSON SCHOOL OF MANAGEMENT
2018-1503 02/23/2018 Moritz College of Law
2018-1504 02/23/2018 Qserve Group US, Inc.
2018-1505 02/23/2018 Viramal Ltd.
2018-1506 02/23/2018 Viramal Ltd.
2018-1507 02/23/2018 Jeffrey Gardner

2018-1508 02/23/2018 Colleen Hershon
University of Texas at Tyler Fisch College of
2018-1509 02/23/2018 Pharmacy
2018-151 01/05/2018 Registrar Corp
2018-1510 02/23/2018 Viramal Ltd.
2018-1511 02/23/2018 Reciprocal Labs Corporation
2018-1512 02/23/2018 OREXO AB
2018-1513 02/23/2018 Viramal Ltd.
2018-1514 02/23/2018 Meridian Bioscience, Inc.
2018-1515 02/23/2018 KETTLE MAGAZINE

2018-1516 02/23/2018 LEE, FRANK M
2018-1517 02/23/2018 Doe J
2018-1518 02/23/2018 MUCKROCK NEWS

2018-1519 02/23/2018 GARDNER BE-8100, JEREMY MICHAEL
2018-152 01/05/2018 Registrar Corp
2018-1520 02/23/2018 CNN IVESTIGATES

2018-1523 02/23/2018 GUERBET LLC
2018-1524 02/23/2018 ZYMERGI INC
2018-1525 02/23/2018 BROWN RUDNICK LLP

2018-1527 02/26/2018 BraunHagey & Borden
2018-1528 02/26/2018 MUCKROCK NEWS
2018-1529 02/26/2018 MUCKROCK NEWS
2018-153 01/05/2018 Registrar Corp
2018-1530 02/26/2018 MUCKROCK NEWS
2018-1531 02/26/2018 MUCKROCK NEWS

2018-1532 02/26/2018 MUCKROCK NEWS
2018-1533 02/26/2018 Artegraft, Inc.

2018-1534 02/26/2018 Inside Fullerton
2018-1535 02/26/2018 Aaron Wedlund
2018-1536 02/26/2018 NATIONAL BIOLOGICAL CORPORATION (NBC)

2018-1537 02/26/2018 FOI Services, Inc.
2018-1538 02/26/2018 Baker & Hostetler LLP
2018-154 01/05/2018 Registrar Corp
2018-1541 02/26/2018 MUCKROCK NEWS
2018-1542 02/26/2018 GSK Consumer Health, Inc.
2018-1543 02/26/2018 MUCKROCK NEWS

2018-1544 02/26/2018 TECNOSS SRL
2018-1545 02/26/2018 MUCKROCK NEWS

2018-1546 02/26/2018 Moderna Therapeutics
2018-1547 02/26/2018 Stinson Leonard Street
2018-1548 02/26/2018 USA TODAY
2018-1549 02/26/2018 Earth Animal Ventures, LLC

2018-155 01/05/2018 Steven Canson
2018-1550 02/26/2018 Flagship Pioneering
2018-1551 02/26/2018 MUCKROCK NEWS

2018-1552 02/26/2018 MUCKROCK NEWS
2018-1553 02/26/2018 MUCKROCK NEWS
2018-1554 02/26/2018 MUCKROCK NEWS

2018-1555 02/26/2018 MUCKROCK NEWS
2018-1556 02/26/2018 MUCKROCK NEWS

2018-1557 02/26/2018 MUCKROCK NEWS
2018-1558 02/27/2018 Ryan Luther
2018-1559 02/27/2018 Alpine Biomed ApS
2018-156 01/05/2018 FOI Services, Inc.
2018-1560 02/27/2018 EdgeOne Medical Inc
2018-1561 02/27/2018 FOI Services, Inc.
2018-1562 02/27/2018 Precision Spine, Inc.
2018-1563 02/27/2018 CHICKEN OF THE SEA INTL

The International Consortium of Investigative
2018-1564 02/27/2018 Journalists
2018-1565 02/27/2018 KUNM News

2018-1566 02/27/2018 LEXAMED
2018-1567 02/27/2018 The Salt Lake Tribune

2018-1568 02/27/2018 Sechrist Industries, Inc.
2018-1569 02/27/2018 KUNM News

2018-157 01/05/2018 Teleflex Inc.

2018-1573 02/27/2018 INTERTEK
2018-1574 02/27/2018 KUNM News
2018-1576 02/27/2018 FOI Services, Inc.
2018-1577 02/27/2018 LEE & HAYES
2018-1578 02/27/2018 Doe J
2018-1579 02/27/2018 MORGAN & AKINS PLLC
2018-158 01/05/2018 LIFE EXTENSION

2018-1580 02/27/2018 Walkup, Melodia, Kelly and Schoenberger

2018-1582 02/27/2018 MOCNIK, GARY
2018-1583 02/27/2018 KITE LAKE CAPITAL MANAGEMENT (UK) LLP

2018-1586 02/27/2018 DILLON, LAUREN

2018-1587 02/28/2018 Center for Environmental Health
2018-1588 02/28/2018 Matrix Medical Devices, LLC
2018-1589 02/28/2018 Medtronic PLC

2018-159 01/05/2018 IPD Analytics, LLC
2018-1590 02/28/2018 LEXAMED
2018-1592 02/28/2018 Medical Device Approvals, Inc.
2018-1593 02/28/2018 Quality Ingredients

2018-1594 02/28/2018 Dentsply SIrona
2018-1595 02/28/2018 KNOBBE MARTENS
2018-1596 02/28/2018 INTERNATIONAL MEDSURG CONNECTION

2018-1599 03/01/2018 FOI Services, Inc.
2018-16 01/02/2018 FOI Services, Inc.
2018-160 01/05/2018 Wright Schimmel LLC
2018-1600 03/01/2018 FOI Services, Inc.
2018-1601 03/01/2018 FOI Services, Inc.
2018-1602 03/01/2018 FOI Services, Inc.
2018-1603 03/01/2018 Dr Ajay Phadke
2018-1604 03/01/2018 Morgan Stanley
2018-1605 03/01/2018 Axis Capital
2018-1606 03/01/2018 ET Now
2018-1609 03/01/2018 Dheeresh Pathak
2018-161 01/05/2018 FOIA GROUP INC
2018-1610 03/01/2018 BLOOMBERG NEWS

2018-1611 03/01/2018 Dr Ajay Phadke
2018-1614 03/01/2018 Donofrio, Ruth

2018-1615 03/01/2018 Bloomberg Quint
2018-1616 03/01/2018 Dr Ajay Phadke
2018-1617 03/01/2018 CREDIT SUISSE
2018-1618 03/01/2018 Dowd & Dowd, PC
2018-1619 03/01/2018 ET Now

2018-162 01/05/2018 FOIA GROUP INC
2018-1620 03/01/2018 ET Now

2018-1621 03/01/2018 Jefferies LLC
2018-1622 03/01/2018 Nathaniel Sheidlower
2018-1623 03/01/2018 Doe J
2018-1625 03/01/2018 Datavant
2018-1626 03/01/2018 Datavant
2018-1627 03/01/2018 Datavant
2018-1628 03/01/2018 Datavant
2018-1629 03/01/2018 Datavant
2018-163 01/05/2018 CITADEL LLC
2018-1630 03/01/2018 Datavant
2018-1631 03/01/2018 Datavant
2018-1632 03/01/2018 Datavant
2018-1633 03/01/2018 Datavant
2018-1634 03/01/2018 Datavant
2018-1635 03/01/2018 Datavant
2018-1636 03/01/2018 Datavant
2018-1637 03/01/2018 Datavant
2018-1638 03/01/2018 Datavant
2018-1639 03/01/2018 Datavant
2018-164 01/05/2018 Merial Inc
2018-1640 03/01/2018 Datavant
2018-1641 03/01/2018 Datavant
2018-1642 03/01/2018 Datavant
2018-1643 03/01/2018 Datavant
2018-1644 03/01/2018 Datavant
2018-1645 03/01/2018 Datavant
2018-1646 03/01/2018 Datavant
2018-1647 03/01/2018 Datavant
2018-1648 03/01/2018 Datavant
2018-1649 03/01/2018 Datavant
2018-165 01/05/2018 Roivant Sciences
2018-1650 03/01/2018 Datavant
2018-1651 03/01/2018 Datavant
2018-1652 03/01/2018 Datavant
2018-1653 03/01/2018 Datavant
2018-1654 03/01/2018 Datavant
2018-1655 03/01/2018 HENRY, A
2018-1656 03/01/2018 CNN IVESTIGATES
2018-1657 03/01/2018 CNN IVESTIGATES
2018-1658 03/01/2018 SIMS 319755, RUSSELL
2018-1659 03/01/2018 PEPPER HAMILTON LLP

2018-1660 03/01/2018 UNIVERSITY OF KENTUCKY MARKET CANCER CENTER
2018-1663 03/01/2018 BUCHANAN INGERSOL PC
2018-1664 03/02/2018 Flexion Therapeutics, Inc.
2018-1665 03/02/2018 Scott C. Fanning

2018-1666 03/02/2018 AdverseEvents, Inc.
2018-1667 03/02/2018 Mumbai
2018-1668 03/02/2018 sayre, chauncey
2018-1669 03/02/2018 Kala Pharmaceuticals
2018-1671 03/02/2018 Jefferies India
2018-1674 03/02/2018 Covance Inc.

2018-1675 03/02/2018 THOMSON REUTERS
2018-1676 03/02/2018 CITADEL LLC


2018-1680 03/02/2018 Tressa Chung
2018-1681 03/02/2018 ET Now

2018-1683 03/02/2018 Lake Partners Strategy Consultants
2018-1684 03/02/2018 Nirmal Bang Institutional Equities
2018-1685 03/02/2018 Dheeresh Pathak
2018-1686 03/02/2018 Edelweiss Services Limited
2018-1688 03/02/2018 IBM
2018-1690 03/05/2018 Dr Ajay Phadke

2018-1691 03/05/2018 Bloomberg Quint
2018-1692 03/05/2018 ET Now
2018-1693 03/05/2018 Prateek Goyal
2018-1694 03/05/2018 Meghal Vakil
2018-1695 03/05/2018 USA TODAY
2018-1696 03/05/2018 FDAAWARE
2018-1697 03/05/2018 Doe J
2018-1698 03/05/2018 TAFT HIGH SCHOOL
2018-1699 03/05/2018 TAFT HIGH SCHOOL
2018-17 01/02/2018 FOI Services, Inc.
2018-170 01/08/2018 Burt Barr & Associates, LLP
2018-1700 03/05/2018 TAFT HIGH SCHOOL
2018-1702 03/05/2018 Mapi Life Sciences Canada
2018-1704 03/05/2018 Egle, Lisa M

2018-1706 03/05/2018 FDANEWS
2018-1707 03/05/2018 Medefil, Inc
2018-1708 03/05/2018 Prateek Goyal
2018-1709 03/05/2018 Prateek Goyal

2018-171 01/08/2018 Stryker AG
2018-1711 03/05/2018 BATLIVALA & KARANI

2018-1712 03/05/2018 Christopher Matera
2018-1713 03/05/2018 Edelweiss Services Limited

2018-1714 03/05/2018 Axis Capital
2018-1716 03/05/2018 G. C. Hanford Manufacturing Company
2018-1717 03/05/2018 ET Now
2018-1719 03/05/2018 GOLDMAN SACHS
2018-172 01/08/2018 JOHNS HOPKINS SCHOOL OF MEDICINE
2018-1722 03/05/2018 SBICAP Securities Limited
2018-1723 03/05/2018 Morgan Stanley
2018-1724 03/05/2018 CREDIT SUISSE
2018-1725 03/05/2018 Emkay Global

2018-1726 03/05/2018 Emkay Global
2018-1727 03/05/2018 Anapol Weiss c/o Tracy Finken
2018-1728 03/05/2018 Bank of America Merrill Lynch
2018-1729 03/05/2018 spencer woodman

2018-1730 03/05/2018 Journalists
2018-1732 03/05/2018 FDAZILLA
2018-1733 03/05/2018 FDAZILLA
2018-1734 03/05/2018 FDAZILLA

HSBC Securities and Capital Markets (India)
2018-1735 03/05/2018 Private Limited
2018-1737 03/05/2018 Dheeresh Pathak
2018-1738 03/05/2018 General Mills - QRO

2018-174 01/08/2018 Cresilon, Inc.
2018-1745 03/05/2018 FDAZILLA

2018-1747 03/05/2018 Jefferies India

2018-175 01/08/2018 COOK INCORPORATED

2018-1751 03/05/2018 Doe J
2018-1752 03/05/2018 M Srinivasa Rao
2018-1753 03/05/2018 Shanghai SUNGO Management Consulting CO., Ltd.
2018-1754 03/05/2018 Doe J
2018-1755 03/05/2018 Fullerton College
2018-1756 03/05/2018 Daniel Bruner

2018-1759 03/05/2018 AMERICAN LUNG ASSOCIATION
2018-176 01/08/2018 Bayer HealthCare Pharmacueticals Inc.
2018-1760 03/05/2018 CLSA India Pvt Ltd
2018-1761 03/05/2018 Equirus Securities Private Limited
2018-1764 03/05/2018 CLSA India Pvt Ltd
2018-1765 03/05/2018 Ascendance Trade LLP
2018-1766 03/05/2018 Utkarsh Gandhi
2018-1767 03/05/2018 Equirus Securities Private Limited

National Institute of Securities Markets Navi
2018-1768 03/05/2018 Mumbai
2018-177 01/08/2018 NDA Partners
2018-1770 03/06/2018 Tiffany & Bosco, P.A.

2018-1771 03/06/2018 BAXTER HEALTHCARE CORPORATION
2018-1772 03/06/2018 ORKEO
2018-1774 03/06/2018 USpharma Ltd
2018-1775 03/06/2018 Prateek Goyal

2018-1776 03/06/2018 truthinadvertising.org
2018-1777 03/06/2018 PLASMA PROTEIN THERAPEUTICS ASSOCIATION
2018-1778 03/06/2018 Prateek Goyal

2018-1779 03/06/2018 WebbWrites
2018-178 01/08/2018 POLITICO
2018-1780 03/06/2018 Peloton Therepeutics
2018-1781 03/06/2018 Pooja Varshneya

2018-1782 03/06/2018 TODD SMITH LAW FIRM
2018-1783 03/06/2018 FOI Services, Inc.
2018-1784 03/06/2018 Medefil, Inc
2018-1786 03/06/2018 Roll Law Group P.C.

2018-1787 03/06/2018 DePuy Orthopaedics, Inc.
2018-1789 03/06/2018 Pedigo Products

2018-1790 03/06/2018 Sarah Rappaport
2018-1792 03/06/2018 FOIA GROUP INC
Nomura Financial Advisory & Securities (India)
2018-1793 03/06/2018 Private Limited
2018-1794 03/06/2018 FOIA GROUP INC
2018-1795 03/06/2018 Prateek Goyal
2018-1796 03/06/2018 Regulatory Compliance Solutions LLC
2018-1797 03/06/2018 CCSi LifeSciences
2018-1798 03/06/2018 Ascend Laboratories, LLC
2018-1799 03/06/2018 RQMIS Inc.
2018-18 01/02/2018 FOI Services, Inc.
2018-180 01/08/2018 Datavant
2018-1800 03/06/2018 SBI Funds Management Private Limited

2018-1803 03/06/2018 LUCAS & CARDENAS
2018-1804 03/06/2018 LINCARE INC
2018-1805 03/06/2018 MILLER & MARTIN PLLC

2018-1806 03/06/2018 SIWOFF LOW VISION CENTER
2018-1807 03/06/2018 MUCKROCK NEWS

2018-1808 03/06/2018 MUCKROCK NEWS
2018-1809 03/06/2018 JEFFREY J DOWNEY LAW OFC

2018-181 01/08/2018 Datavant
2018-1810 03/06/2018 HELLMANN, JESSIE
2018-1811 03/06/2018 FREEMAN MATHIS & GARY LLP

2018-1813 03/06/2018 GENCIA LLC
2018-1814 03/06/2018 BEHR MCCARTER & POTTER PC
2018-1815 03/06/2018 CAPES SOKOL GOODMAN & SARACHAN PC
2018-1818 03/06/2018 LINCOLN JOURNAL STAR

2018-1819 03/06/2018 GANDHI, SHIV
2018-182 01/08/2018 Datavant
2018-1820 03/06/2018 PULSE BIOSCIENCES

2018-1821 03/06/2018 MUCKROCK NEWS
2018-1822 03/06/2018 Ironwood Pharmaceuticals, Inc.
2018-1823 03/06/2018 GENCIA LLC

2018-1824 03/06/2018 INVERSAGO PHARMA INC
2018-1825 03/06/2018 Norton Rose Fulbright US LLP
2018-1826 03/06/2018 DCCC

2018-1827 03/06/2018 Doe J
2018-1829 03/06/2018 HEWLETT, IRIS

2018-183 01/08/2018 Datavant
2018-1830 03/06/2018 QUINLAN
2018-1831 03/06/2018 QUINLAN

2018-1835 03/07/2018 Christiansen Davis LLC
2018-1836 03/07/2018 Christiansen Davis LLC


2018-1841 03/07/2018 JAG Healthcare Consulting LLC
2018-1842 03/07/2018 Stryker AG
Johns Hopkins Bloomberg School of Public Health,
2018-1843 03/07/2018 Department of Epidemiology
The Dartmouth Institute for Health Policy &
2018-1844 03/07/2018 Clinical Practice
2018-1845 03/07/2018 THE GEORGE WASHINGTON UNIVERSITY
2018-1846 03/07/2018 BLOOMBERG NEWS
2018-1847 03/07/2018 martin rostoker

2018-185 01/08/2018 Fleet Laboratories
2018-1850 03/07/2018 GUANGZHOU NUCIEN PHARMACEUTICAL CO.,LTD.

2018-1854 03/07/2018 Sarah Rappaport
2018-1855 03/07/2018 Summer Road

2018-1857 03/07/2018 CREDIT SUISSE
2018-1858 03/07/2018 FOI Services, Inc.
2018-1859 03/07/2018 FOI Services, Inc.

2018-186 01/08/2018 FOI Services, Inc.
2018-1860 03/07/2018 KinderPharm LLC

2018-1862 03/07/2018 SIEMENS HEALTHCARE DIAGNOSTICS INC
2018-1863 03/07/2018 FOI Services, Inc.

2018-1865 03/07/2018 AntibioTx A/S
2018-1866 03/07/2018 Dr Ajay Phadke
2018-1867 03/07/2018 FOIA GROUP INC

2018-1868 03/07/2018 Raycom Media
2018-1869 03/07/2018 G. C. Hanford Manufacturing Company



2018-1875 03/07/2018 Prescient Healthcare Group
2018-1877 03/07/2018 NBC NEWS
2018-1878 03/07/2018 MILWAUKEE JOURNAL SENTINEL

2018-1881 03/07/2018 NATURAL PRODUCTS ASSOCIATION
2018-1885 03/07/2018 JM HUBER CORP
2018-1886 03/07/2018 ENZYMEDEVELOPMENT CORP
2018-1887 03/07/2018 WASHINGTON POST

2018-1889 03/07/2018 HAHN LOESER PARKS
2018-189 01/08/2018 Datavant
2018-1890 03/07/2018 MacDonald Law Group LLC
2018-1891 03/07/2018 NASH & FRANCISKATO LAW FIRM
2018-1894 03/07/2018 DCCC

2018-1895 03/08/2018 Northgate Technologies, Inc.
2018-1896 03/08/2018 DCCC
2018-1897 03/08/2018 Paul Gehris
2018-1898 03/08/2018 Sparhawk Laboratories Inc.

2018-19 01/02/2018 THERANEXUS
2018-190 01/08/2018 Datavant
2018-1900 03/08/2018 COLLEGIUM PHARMACEUTICAL
2018-1902 03/08/2018 CCB Packaging, Inc.

2018-1904 03/08/2018 Winston & Strawn, LLP

2018-1905 03/08/2018 Gerry Hickey
2018-1907 03/08/2018 FDAZILLA
2018-1908 03/08/2018 Zymergi, Inc.

2018-1909 03/08/2018 Registrar Corp
2018-191 01/08/2018 Datavant
2018-1910 03/08/2018 Registrar Corp
2018-1911 03/08/2018 Teligent Pharma, Inc.
2018-1912 03/08/2018 Registrar Corp
2018-1913 03/08/2018 FDAZILLA

2018-1914 03/08/2018 Christopher Remshaw
2018-1916 03/08/2018 Hendall Inc.
2018-1918 03/08/2018 FOIA GROUP INC
2018-1919 03/08/2018 FDAZILLA

2018-192 01/08/2018 Ronald F Miszewski
2018-1922 03/08/2018 McDermott Will & Emery LLP
2018-1924 03/08/2018 FOIA GROUP INC
2018-1925 03/08/2018 FDAZILLA

2018-1926 03/08/2018 REVA Medical, Inc.
2018-1927 03/08/2018 ChemDesign

2018-1928 03/08/2018 FOI Services, Inc.
2018-1929 03/08/2018 Deutsche Equities India Pvt. Ltd.
2018-193 01/08/2018 Datavant
2018-1930 03/08/2018 Prateek Goyal

2018-1931 03/08/2018 Annie Xu
2018-1933 03/08/2018 Charles Seife
2018-1935 03/08/2018 Deutsche Equities India Pvt. Ltd.
2018-1936 03/08/2018 Prometheus Laboratories Inc.
2018-1937 03/08/2018 Doe J
2018-1938 03/09/2018 FOI Services, Inc.
2018-1939 03/09/2018 LOEB & LOEB LLP

2018-194 01/08/2018 Datavant
2018-1940 03/09/2018 Eric Kirk
2018-1941 03/09/2018 Emma Isakson
2018-1942 03/09/2018 Dolt, Thompson, Shepherd & Conway
2018-1943 03/09/2018 bruce goodman
2018-1944 03/09/2018 GENCIA LLC
2018-1945 03/09/2018 GENCIA LLC
2018-1946 03/09/2018 sadowski, luke

2018-1947 03/09/2018 Dolt, Thompson, Shepherd & Conway
2018-1948 03/09/2018 FOOD SAFETY NEWS

2018-1949 03/09/2018 Advyzom
2018-195 01/08/2018 Chickasaw Nation Industries
2018-1951 03/09/2018 FOI Services, Inc.
2018-1952 03/09/2018 Unger Consulting, Inc.

2018-1953 03/09/2018 Amey Chalke
2018-1954 03/09/2018 University of Washington, School of Pharmacy
2018-1955 03/09/2018 FOI Services, Inc.

2018-1956 03/09/2018 TESARO
2018-1957 03/09/2018 Buzzfeed News
2018-1958 03/09/2018 Syndax Pharmaceuticals, Inc.
2018-1959 03/09/2018 TESARO
2018-196 01/08/2018 Datavant
2018-1960 03/09/2018 Dermer Appel Ruder LLC

2018-1961 03/09/2018 Sayan Manna
2018-1964 03/09/2018 Inceptus Medical
2018-1966 03/09/2018 Aaren Scientific Inc.
2018-1967 03/09/2018 FOI Services, Inc.

2018-197 01/08/2018 Ronald F Miszewski
2018-1970 03/09/2018 Deanna Kellen

2018-1971 03/09/2018 rishabhsecurities
2018-1972 03/09/2018 DANA-FARBER CANCER INSTITUTE
2018-1973 03/09/2018 Private Limited
2018-1974 03/09/2018 Doe J
2018-1976 03/12/2018 Salmon, Ricardo A
2018-1978 03/12/2018 WOOD BURDITT GROUP
2018-1979 03/12/2018 Beveridge & diamond, P.C.
2018-198 01/08/2018 Gentherm
2018-1981 03/12/2018 FDAAWARE
2018-1982 03/12/2018 Endris Consulting, Inc. (Richard Endris)
2018-1984 03/12/2018 samuel panos

2018-1985 03/12/2018 Ross Ziev
2018-1986 03/12/2018 SHIRE PHARMACEUTICALS INC

2018-1988 03/12/2018 LEHIGH VALLEY HOSPITAL
2018-1989 03/12/2018 Dr Ajay Phadke
2018-199 01/08/2018 ICU Medical, Inc.

2018-1990 03/12/2018 Allan N. Karlin & Assocaites
2018-1991 03/12/2018 Prateek Goyal

2018-1992 03/12/2018 ZUCKERMAN SPAEDER LLP
2018-1993 03/12/2018 Bridger Management, LLC
2018-1994 03/12/2018 BIOMERIEUX, INC

2018-1996 03/12/2018 University of Oregon School of Law
2018-1997 03/12/2018 KUNM News
2018-1998 03/12/2018 Almirall S.A.
2018-1999 03/12/2018 Cycle Pharmaceuticals Ltd.
2018-2 01/02/2018 Memorial Hermann Memorial City Medical Center
2018-20 01/02/2018 MIZUHO SECURITIES USA INC

2018-2000 03/12/2018 ABC NEWS
2018-2001 03/12/2018 UNIVERSITY OF WASHINGTON
2018-2002 03/12/2018 NEW YORK TIMES
2018-2003 03/12/2018 BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.

2018-2006 03/12/2018 FOI Services, Inc.
2018-2007 03/12/2018 FOI Services, Inc.
2018-2008 03/12/2018 Yeroushalmi & Yeroushalmi

2018-2009 03/12/2018 GENCIA LLC
2018-201 01/08/2018 UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER

2018-2010 03/12/2018 Sakai Regulatory Consulting
2018-2011 03/12/2018 ANAPOLWEISS
2018-2012 03/12/2018 FOI Services, Inc.
2018-2013 03/12/2018 Stryker AG
2018-2014 03/12/2018 Ecolab Inc. Attn: Charles Pouliot

2018-2015 03/12/2018 IQVIA
2018-2017 03/12/2018 IQVIA
2018-2018 03/12/2018 TriHealth Pharmacy
2018-2019 03/12/2018 BLOOMBERG NEWS
2018-202 01/08/2018 COOK INCORPORATED

2018-2020 03/12/2018 Allergan, plc
2018-2021 03/12/2018 Ecolab Inc. Attn: Charles Pouliot

2018-2022 03/12/2018 FOI Services, Inc.
2018-2023 03/12/2018 FOI Services, Inc.
2018-2024 03/12/2018 FOI Services, Inc.
2018-2025 03/12/2018 DLD Investigations
2018-2026 03/12/2018 Emeraldwise
2018-2027 03/12/2018 Paul E. Danchell A/S
2018-2028 03/12/2018 MC Resource Development

2018-2029 03/12/2018 Cycle Pharmaceuticals Ltd.
2018-203 01/08/2018 Jerome Goldsein, MD
2018-2030 03/12/2018 FAEGRE BAKER DANIELS

2018-2032 03/12/2018 Cook, Little, Rosenblatt & Manson, p.l.l.c.
2018-2033 03/12/2018 CONWAY HOMER PC
2018-2036 03/12/2018 BLANK ROME LLP

2018-2038 03/12/2018 MUCKROCK NEWS
2018-2039 03/12/2018 EpiSource, LLC
2018-204 01/08/2018 Safkhet Capital Management LLC

2018-2040 03/12/2018 Zymergi, Inc.
2018-2042 03/12/2018 WASHINGTON EXAMINER
2018-2043 03/13/2018 Lt Rose I James JD

2018-2044 03/13/2018 FOI Services, Inc.

2018-2047 03/13/2018 WebMD
2018-2049 03/13/2018 PROPUBLICA

Sanford Burnham Prebys Medical Discovery
2018-205 01/08/2018 Institute
2018-2050 03/13/2018 STAT
2018-2051 03/13/2018 White, Davis, and White Law Firm

2018-2052 03/13/2018 Jefferies LLC
2018-2053 03/13/2018 OPKO Diagnostics, LLC
2018-2054 03/13/2018 FOI Services, Inc.
2018-2055 03/13/2018 FOI Services, Inc.
2018-2056 03/13/2018 FOI Services, Inc.
2018-2057 03/13/2018 New York Public Radio
2018-2058 03/13/2018 Crain's Cleveland Business

2018-2059 03/13/2018 THE UNIVERSITY OF TEXAS AT AUSTIN
2018-206 01/08/2018 BAUM HEDLUND ET AL

2018-2060 03/13/2018 P & L Developments, LLC
2018-2061 03/13/2018 DCM
2018-2062 03/13/2018 FOI Services, Inc.
2018-2063 03/13/2018 FOI Services, Inc.
2018-2064 03/13/2018 FOI Services, Inc.
2018-2065 03/13/2018 Key Surgical, Inc.
2018-2066 03/13/2018 Teikoku Pharma USA, Inc.
2018-2067 03/13/2018 Dr. Reddy’s Laboratories Inc
2018-2069 03/13/2018 United Safety Agents, LLC

2018-2070 03/13/2018 FOI Services, Inc.
2018-2071 03/13/2018 HemoCue America
2018-2073 03/13/2018 The Capitol Forum

2018-2074 03/13/2018 PARAGON VISION SCIENCES
2018-2075 03/13/2018 ANI Pharmaceuticals, Inc.
2018-2077 03/13/2018 FDA NEWS
2018-2078 03/13/2018 FOI Services, Inc.

2018-2084 03/13/2018 FDA NEWS
2018-2085 03/13/2018 FOI Services, Inc.
2018-209 01/08/2018 COSMETIC INGEDIENT REVIEW

2018-2091 03/13/2018 FOI Services, Inc.
2018-2095 03/13/2018 FOI Services, Inc.
2018-2098 03/14/2018 WILEY REIN LLP
2018-2099 03/14/2018 Preg O'Donnell & GIllett

2018-21 01/02/2018 Pennock Law Firm

2018-2100 03/14/2018 Prince Agri Products, Inc.
2018-2105 03/14/2018 Marino, Steven F
2018-2106 03/14/2018 Marino, Steven F
2018-2107 03/14/2018 FOI Services, Inc.
2018-2108 03/14/2018 FOI Services, Inc.
2018-2109 03/14/2018 Nitto Avecia Pharma Services, Inc.
2018-211 01/08/2018 SACKS TIERNEY P.A. LAWYERS

2018-2110 03/14/2018 Sleep Science Partners Inc
2018-2111 03/14/2018 Faegre Baker Daniels LLP
2018-2112 03/14/2018 Dr Ajay Phadke

2018-2113 03/14/2018 FORTUNE MAGAZINE
National Institute of Securities Markets Navi
2018-2114 03/14/2018 Mumbai
2018-2115 03/14/2018 Glenmark Pharmaceuticals Inc

2018-2116 03/14/2018 Aaron King
2018-2117 03/14/2018 Keck Graduate Institute
2018-2118 03/14/2018 Lumendi, LLC
2018-2119 03/15/2018 FDAAWARE

2018-2120 03/15/2018 FDAAWARE
2018-2121 03/15/2018 FOI Services, Inc.
2018-2122 03/15/2018 RAY THOMPSON
2018-2123 03/15/2018 RAY THOMPSON

2018-2127 03/15/2018 RAY THOMPSON

2018-2128 03/15/2018 FOI Services, Inc.
2018-2129 03/15/2018 SHIRE
2018-213 01/08/2018 LORI A CARR INC
2018-2130 03/15/2018 SoftRay Incorporated
2018-2131 03/15/2018 Muller Brazil, LLP
2018-2132 03/15/2018 RAY THOMPSON
2018-2133 03/15/2018 RAY THOMPSON
2018-2134 03/15/2018 RAY THOMPSON
2018-2135 03/15/2018 RAY THOMPSON

2018-2136 03/15/2018 FDA NEWS
2018-2137 03/15/2018 FOI Services, Inc.
2018-2138 03/15/2018 FOI Services, Inc.
2018-2139 03/15/2018 long wei revoe asia limited

2018-2142 03/15/2018 PaxMed Intenational, LLC
2018-2143 03/15/2018 Faruqi and Faruqi, LLP
2018-2144 03/15/2018 Scott Schlager, Esq., Nathanson & Goldberg, P.C.

2018-2145 03/15/2018 FOI Services, Inc.
2018-2146 03/15/2018 FOI Services, Inc.
2018-2147 03/15/2018 FOI Services, Inc.
2018-2148 03/15/2018 P & L Development, LLC
2018-2149 03/15/2018 FOI Services, Inc.
2018-2150 03/15/2018 COUNCIL FOR RESPONSIBLE NUTRITION
Federal Public Defender-Middle District of
2018-2151 03/15/2018 Tennessee
2018-2152 03/15/2018 FOI Services, Inc.
2018-2154 03/15/2018 FINKELSTEIN & PARTNERS
2018-2155 03/15/2018 Kite Pharma
2018-2156 03/15/2018 CITY OF ST CLOUD MINNESOTA
2018-2157 03/15/2018 COUNCIL FOR RESPONSIBLE NUTRITION
2018-2158 03/15/2018 ZIAEE, DONYA
2018-2159 03/15/2018 HITCH, MARY
2018-216 01/08/2018 PACIFIC BIOLABS
2018-2160 03/15/2018 MERRILL, SANDRA

NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND
2018-2161 03/15/2018 STROKE
2018-2162 03/15/2018 BASF Corporation
2018-2163 03/15/2018 LOEB & LOEB LLP
2018-2164 03/15/2018 McEldrew Young
2018-2165 03/15/2018 SEED IP
2018-2166 03/15/2018 LORI A CARR INC
2018-2167 03/15/2018 LORI A CARR INC
2018-2168 03/15/2018 LORI A CARR INC
2018-2169 03/16/2018 Dr Ajay Phadke
2018-217 01/08/2018 PLAGER SCHACK LLP
2018-2171 03/16/2018 FOI Services, Inc.
2018-2172 03/16/2018 FOI Services, Inc.
2018-2173 03/16/2018 FOI Services, Inc.
2018-2174 03/16/2018 PROPUBLICA
2018-2175 03/16/2018 INTERTEK
2018-2176 03/16/2018 Cipla Limited
2018-2178 03/16/2018 Floyd, Pflueger & Ringer, P.S.

2018-2179 03/16/2018 Mark Campbell
2018-2180 03/16/2018 PRICEWATERHOUSECOOPERS LLP

2018-2182 03/16/2018 ET Now
2018-2184 03/16/2018 Symmetry Surgical
2018-2185 03/16/2018 Kenneth Duchin
2018-2186 03/16/2018 FOI Services, Inc.
2018-2187 03/16/2018 FDAZILLA

2018-2188 03/16/2018 FOI Services, Inc.
2018-2189 03/16/2018 FOI Services, Inc.
2018-2190 03/16/2018 David Horn
2018-2191 03/16/2018 FOI Services, Inc.
2018-2194 03/16/2018 GoodResearch
2018-2195 03/16/2018 FDAZILLA
2018-2196 03/16/2018 GoodResearch
2018-2197 03/16/2018 DCCC
2018-2198 03/16/2018 DANIEL R MORDARSKI LLC

2018-2200 03/16/2018 AVRAM BLAIR & ASSOCIATES PC

2018-2201 03/16/2018 Brodhead Law, LLC
2018-2202 03/16/2018 Brodhead Law, LLC
2018-2203 03/16/2018 Brodhead Law, LLC
2018-2204 03/16/2018 Brodhead Law, LLC
2018-2205 03/16/2018 Brodhead Law, LLC
2018-2206 03/16/2018 Weisman, Kennedy & Berris

2018-2207 03/16/2018 MONDA, AINSLEY
2018-2208 03/16/2018 POWER ROGERS & SMITH LLP
2018-2209 03/16/2018 Sommetrics Inc.
2018-2210 03/16/2018 DLA PIPER LLP US

2018-2211 03/16/2018 MAHER AVOCAT, ME MICHEL

2018-2213 03/16/2018 Sangfroid, Jack
2018-2214 03/19/2018 FOI Services, Inc.

2018-2215 03/19/2018 Arvind Radhakrishna
2018-2216 03/19/2018 FOI Services, Inc.
2018-2217 03/19/2018 FOI Services, Inc.
2018-2218 03/19/2018 CASE WESTERN RESERVE UNIVERSITY
2018-2220 03/19/2018 FOI Services, Inc.
2018-2221 03/19/2018 FOI Services, Inc.
2018-2222 03/19/2018 Prozio Bromberg & Newman P.C.
2018-2223 03/19/2018 FOI Services, Inc.
2018-2224 03/19/2018 FOI Services, Inc.
2018-2225 03/19/2018 DePuy Synthes Mitek
2018-2226 03/19/2018 Boston Scientific Corporation
2018-2228 03/19/2018 Acerta Pharma

2018-2229 03/19/2018 BECTON, DICKINSON AND COMPANY
2018-223 01/08/2018 FOUR RIVERS CLINICAL RESEARCH
2018-2230 03/19/2018 Jerome Pando
2018-2231 03/19/2018 RAY THOMPSON

2018-2233 03/19/2018 Radius Health
2018-2234 03/19/2018 MEDTRONIC

2018-2236 03/19/2018 Sandy McGeever

2018-2239 03/19/2018 BLOOMBERG NEWS
2018-224 01/08/2018 MUCKROCK NEWS
2018-2240 03/19/2018 Mintz Levin Cohn Ferris Glovsky & Popeo PC

2018-2241 03/19/2018 SIRI & GLIMSTAD LLP

2018-2245 03/19/2018 TruthaboutPetFood.com

2018-2247 03/20/2018 Regulatory Professionals, Inc.
2018-2248 03/20/2018 FOI Services, Inc.

2018-225 01/08/2018 OCUGEN INC

2018-2250 03/20/2018 Ethicon, Inc.
2018-2251 03/20/2018 FOI Services, Inc.
2018-2252 03/20/2018 FOI Services, Inc.
2018-2253 03/20/2018 PROPUBLICA

2018-2254 03/20/2018 MUCKROCK NEWS
2018-2256 03/20/2018 Elanco Animal Health - Kelly Perfield
2018-2258 03/20/2018 Kite Pharma
2018-2259 03/20/2018 Doe J
2018-226 01/09/2018 FOLEY, BARON, METZGER & JUIP,
2018-2260 03/20/2018 PROPUBLICA
2018-2261 03/20/2018 DLA Piper LLP (US)

2018-2262 03/20/2018 FOI Services, Inc.
2018-2263 03/20/2018 Nivagen Pharmaceuticals, Inc.

2018-2267 03/20/2018 FOIA GROUP INC
2018-2268 03/20/2018 FOI Services, Inc.
2018-2269 03/20/2018 WRC-TV

2018-2270 03/20/2018 Neural Analytics

2018-2273 03/20/2018 Pyros Pharma

2018-2277 03/20/2018 University of Washington, School of Pharmacy
2018-2278 03/20/2018 Dongsuk Shin

2018-2280 03/20/2018 Doe J
2018-2281 03/20/2018 Doe J
2018-2282 03/20/2018 Valerie Tolbert

2018-2284 03/20/2018 FOIA GROUP INC
2018-2285 03/20/2018 Bahney Lab (UCSF)
Texas A&M Health Sciences Center,Irma Lerma
2018-2286 03/20/2018 Rangel College of Pharmacy
2018-2287 03/20/2018 FURMAN, MICHAEL
2018-2288 03/20/2018 KEYS 22458017, CLAY
2018-2289 03/20/2018 Doe J

2018-2290 03/20/2018 GLAWE, JUSTIN
2018-2291 03/20/2018 ROBAK, DAVID
2018-2292 03/20/2018 ROBAK, DAVID

2018-2293 03/21/2018 Private Limited
2018-2294 03/21/2018 Morgan Stanley
2018-2295 03/21/2018 TEXAS TECH UNIVERSITY
2018-2296 03/21/2018 ENVISAGE CONSULTING LLC
2018-2297 03/21/2018 FDAZILLA

2018-2298 03/21/2018 UNIVERSITY OF GEORGIA
2018-2299 03/21/2018 Tennessee
2018-23 01/02/2018 Lisa Weber
2018-2301 03/21/2018 FDAZILLA

2018-2303 03/21/2018 Tennessee
2018-2304 03/21/2018 Pyros Pharma
2018-2305 03/21/2018 Henningsen Cold Storage Co.
2018-2306 03/21/2018 FDAZILLA
2018-2307 03/21/2018 FDAZILLA
2018-2308 03/21/2018 FDAZILLA
2018-2309 03/21/2018 Evidation Health

2018-2311 03/21/2018 Peter Blok
2018-2312 03/21/2018 FDAZILLA
2018-2313 03/21/2018 ECOG-ACRIN

2018-2314 03/21/2018 NTK Network
2018-2315 03/21/2018 FOOD SAFETY NEWS

2018-2317 03/21/2018 wolbach, carla
2018-2318 03/21/2018 FDAZILLA

2018-232 01/09/2018 Acella Pharmaceuticals, LLC

2018-2320 03/21/2018 CNN
2018-2322 03/21/2018 Lacrimedics, Inc.
2018-2323 03/21/2018 NXSTAGE MEDICAL INC
2018-2324 03/21/2018 Dow Silicones Corporation
2018-2325 03/21/2018 Fruit of the Earth, Inc.
2018-2326 03/21/2018 BATLIVALA KARANI

2018-2328 03/21/2018 FOIA GROUP INC

2018-2329 03/21/2018 Dulari Batra

2018-2330 03/21/2018 Prateek Goyal
2018-2331 03/22/2018 Graciela Tena de Lara
2018-2332 03/22/2018 CREDIT SUISSE
2018-2333 03/22/2018 Blood Bank of Delmarva
2018-2334 03/22/2018 FDAZILLA
2018-2335 03/22/2018 FDAZILLA
2018-2336 03/22/2018 FDAZILLA
2018-2337 03/22/2018 Cuneo Gilbert & LaDuc

2018-2338 03/22/2018 Dr Ajay Phadke
2018-2339 03/22/2018 PurColour, Inc.
2018-234 01/09/2018 Amy Lynn
2018-2340 03/22/2018 FOI Services, Inc.
2018-2341 03/22/2018 Cook Medical
2018-2342 03/22/2018 Scott Thiel

2018-2343 03/22/2018 Randy Brenner
2018-2344 03/22/2018 Wegmans Food Markets, Inc.
2018-2345 03/22/2018 EVI, Inc.
2018-2346 03/22/2018 FOI Services, Inc.
2018-2347 03/22/2018 CNN
2018-2348 03/22/2018 Lonza Inc.
2018-2349 03/22/2018 WAGSTAFF & CARTMELL LLP
2018-235 01/09/2018 Cadian Capital
2018-2350 03/22/2018 Wagstaff & Cartmell LLP- Attn Andrew Faes
2018-2351 03/22/2018 FOI Services, Inc.
2018-2353 03/22/2018 FOI Services, Inc.
2018-2354 03/22/2018 FOI Services, Inc.
2018-2355 03/22/2018 Yukevich Cavenaugh
2018-2356 03/22/2018 Synonymy
2018-2357 03/22/2018 FOI Services, Inc.
2018-2358 03/22/2018 Cocoburg LLC
2018-2359 03/22/2018 FOI Services, Inc.

2018-2360 03/22/2018 Kala Pharmaceuticals, Inc.
2018-2361 03/22/2018 Doe J
2018-2362 03/22/2018 FDA NEWS
2018-2363 03/22/2018 FDA NEWS
2018-2364 03/22/2018 FDA NEWS
2018-2365 03/22/2018 Private Limited
2018-2366 03/22/2018 ET Now

2018-2368 03/22/2018 Doe J
2018-2369 03/22/2018 Icahn School of Medicine at Mount Sinai
2018-237 01/09/2018 CENTRAL SOLUTIONS INC

2018-2370 03/22/2018 Bayer Health Care LLC

2018-2372 03/22/2018 FDANEWS
2018-2373 03/22/2018 FDA NEWS
2018-2374 03/22/2018 FDA NEWS
2018-2375 03/22/2018 FDA NEWS
2018-2376 03/22/2018 FDA NEWS
2018-2377 03/22/2018 Align Technology
2018-2378 03/22/2018 FOI Services, Inc.
2018-2379 03/22/2018 Susan Devick
2018-238 01/09/2018 Conba USA Inc
2018-2380 03/22/2018 The Ohio State University Wexner Medical Center

2018-2381 03/22/2018 FDA NEWS
2018-2382 03/22/2018 FDA NEWS
2018-2383 03/22/2018 FDA NEWS
2018-2384 03/22/2018 FDA NEWS
2018-2385 03/22/2018 FDA NEWS
2018-2386 03/22/2018 FDA NEWS
2018-2387 03/22/2018 FDA NEWS
2018-2388 03/22/2018 FDA NEWS
2018-2389 03/22/2018 FDA NEWS
2018-239 01/09/2018 FOI Services, Inc.

2018-2390 03/22/2018 FDANEWS
2018-2391 03/22/2018 FDA NEWS

2018-2392 03/22/2018 FDA NEWS
2018-2393 03/22/2018 FDA NEWS
2018-2394 03/22/2018 FDA NEWS
2018-2395 03/22/2018 FDA NEWS
2018-2397 03/23/2018 Rutgers Center for Tobacco Studies

2018-2399 03/23/2018 Doe J
2018-240 01/09/2018 CONNECTICUT HEALTH INVESTIGATIVE TEAM

2018-2400 03/23/2018 Paragon BioTeck, Inc.
2018-2401 03/23/2018 Semalytix GmbH
2018-2402 03/23/2018 ET Now

2018-2403 03/23/2018 BROWN UNIVERSITY
2018-2404 03/23/2018 LEONARD LAMB

2018-2406 03/23/2018 Biological E. Limited

2018-2408 03/23/2018 Jamila Murga
2018-2409 03/23/2018 STAT / Boston Globe
2018-241 01/09/2018 Cortical Metrics, LLC

2018-2410 03/23/2018 Doe J
2018-2412 03/23/2018 SCHNUCKS MARKETS INC
2018-2413 03/23/2018 Buzzfeed News

2018-2414 03/23/2018 HENNESSY, JEREMY
2018-2415 03/23/2018 STANFORD UNIVERSITY
2018-2416 03/23/2018 Unger Consulting, Inc.

2018-2417 03/23/2018 joeris, Leonard
2018-2418 03/23/2018 joeris, Leonard
2018-2419 03/23/2018 joeris, Leonard
2018-2420 03/26/2018 PROPUBLICA
2018-2421 03/26/2018 DCM
2018-2422 03/26/2018 DCM
2018-2423 03/26/2018 FOOD SAFETY NEWS

2018-2424 03/26/2018 FOI Services, Inc.
2018-2425 03/26/2018 Jefferies LLC
2018-2426 03/26/2018 Kala Pharmaceuticals
2018-2427 03/26/2018 FOI Services, Inc.

2018-2429 03/26/2018 Michael S. Gusel

2018-2431 03/26/2018 FOI Services, Inc.
Federal Public Defender- Middle District of
2018-2432 03/26/2018 Tennessee
2018-2433 03/26/2018 FOI Services, Inc.
2018-2434 03/26/2018 SANOFI
2018-2436 03/26/2018 jeff gardner
2018-2437 03/26/2018 BLOOMBERG LP

2018-2439 03/26/2018 King & Prince Seafood Corp.

2018-244 01/09/2018 Dale Holdings Incorporated
2018-2440 03/26/2018 Harvard College
2018-2443 03/26/2018 Guardian Drug Company
2018-2445 03/26/2018 Gregory Fairnak
2018-2446 03/26/2018 FOI Services, Inc.
2018-2447 03/26/2018 FOI Services, Inc.
2018-2449 03/26/2018 Medicamex, S.A. DE C.V.
2018-245 01/09/2018 DCM
2018-2450 03/26/2018 ET Now

2018-2451 03/26/2018 MEDLINE INDUSTRIES INC
2018-2452 03/26/2018 Huvepharma, Inc.
2018-2453 03/26/2018 Scheef & Stone, LLP
2018-2454 03/26/2018 USpharma Ltd
2018-2455 03/26/2018 Kaufman Dolowich & Voluck, LLP

2018-2456 03/26/2018 Vici Health Sciences
2018-2457 03/26/2018 Quentin de Snoeck
2018-2458 03/26/2018 Cox Biosciences

2018-2459 03/26/2018 DCCC
2018-246 01/09/2018 CORCEPT THERAPEUTICS INC
2018-2460 03/26/2018 FOI Services, Inc.
2018-2461 03/26/2018 DAVOL INC
2018-2462 03/26/2018 Fresenius Kabi USA, LLC
2018-2463 03/26/2018 Doe J
2018-2464 03/26/2018 Quentin de Snoeck
2018-2466 03/26/2018 Sion Biotext Medical Ltd.
2018-2467 03/26/2018 Quality and Regulatory Associates, LLC
2018-2468 03/26/2018 FOI Services, Inc.
2018-2469 03/26/2018 Cylas Hall
2018-247 01/09/2018 DCM
2018-2470 03/26/2018 FDAZILLA
2018-2471 03/26/2018 FDAZILLA

2018-2472 03/26/2018 FDAZILLA
2018-2473 03/26/2018 Doe J
2018-2474 03/26/2018 FDAZILLA
2018-2476 03/26/2018 FDAZILLA
2018-2477 03/26/2018 NTK Network
2018-2478 03/26/2018 FARUQI & FARUQI LLP
2018-2479 03/26/2018 Twin Capital Management

2018-248 01/09/2018 Dicerna Pharmaceuticals
2018-2480 03/26/2018 Eileen Webster

2018-2482 03/26/2018 Cerf, Clarence L
2018-2483 03/26/2018 MUCKROCK NEWS

2018-2484 03/26/2018 LORI A CARR INC
2018-2485 03/26/2018 MORGAN & AKINS PLLC
2018-2486 03/26/2018 GARY F FRANKE CO LPA
2018-2488 03/26/2018 American Oversight

2018-2489 03/26/2018 DCCC
2018-249 01/09/2018 Dr Ajay Phadke
2018-2490 03/26/2018 joeris, Leonard
2018-2491 03/26/2018 FOI Services, Inc.
2018-2492 03/26/2018 GREGORY #227394, CLARENCE
2018-2493 03/26/2018 ALDER LAW PC
2018-2494 03/26/2018 ALDER LAW PC

2018-2495 03/26/2018 ALDER LAW PC
2018-2497 03/27/2018 SULTZER LAW GROUP PC
2018-2498 03/27/2018 Registrar Corp

2018-25 01/02/2018 FOI Services, Inc.

2018-2502 03/27/2018 THE RESEARCH INVESTMENT, INC.
2018-2503 03/27/2018 Paul Gehris
2018-2504 03/27/2018 EARLY SULLIVAN WRIGHT GIZER & MCRAE LLP
2018-2505 03/27/2018 MCGUIREWOODS LLP
2018-2506 03/27/2018 CONSTELLATION BRANDS

2018-2507 03/27/2018 Doe J
2018-2508 03/27/2018 Pirouette Medical, LLC.
2018-2511 03/27/2018 SOOKA INC
2018-2512 03/27/2018 FOI Services, Inc.
2018-2513 03/27/2018 FOI Services, Inc.
2018-2514 03/27/2018 FOI Services, Inc.
2018-2515 03/27/2018 FOI Services, Inc.
2018-2516 03/27/2018 BTIG LLC

2018-252 01/09/2018 Enigma Technologies, Inc

2018-2520 03/27/2018 FOI Services, Inc.

2018-2523 03/27/2018 KCI USA, Inc.
2018-2524 03/27/2018 Lifemax Laboratories, Inc.
2018-2525 03/27/2018 Meg McLean

2018-2526 03/27/2018 QILU ANIMAL HEALTH PRODUCTS CO., LTD.
2018-2527 03/27/2018 KCI USA, INC.
2018-2528 03/27/2018 RedLeaf Biologics, Inc.
2018-2530 03/27/2018 The Ohio State University Wexner Medical Center

2018-2531 03/27/2018 Reuters News
2018-2532 03/27/2018 WRIC-TV, Kerri O'Brien
2018-2534 03/27/2018 The Rosen Law Firm PA
2018-2535 03/27/2018 STAT

2018-2536 03/27/2018 SullivanIP Solutions
2018-2537 03/27/2018 GlobalData
2018-2539 03/28/2018 PATH

2018-2542 03/28/2018 AlvaMed, Inc.

2018-2545 03/28/2018 Human Xtensions Ltd.
2018-2546 03/28/2018 Stephanie Anderson
2018-2547 03/28/2018 Private Practice Leadership, LLC

2018-2548 03/28/2018 FOI Services, Inc.
2018-2549 03/28/2018 FOI Services, Inc.
2018-2550 03/28/2018 FOI Services, Inc.
2018-2551 03/28/2018 FOI Services, Inc.
2018-2552 03/28/2018 FOI Services, Inc.
2018-2553 03/28/2018 FOI Services, Inc.
2018-2554 03/28/2018 JFC International Inc.

2018-2555 03/28/2018 Doe J
2018-2556 03/28/2018 Terumo Medical Corporation
2018-2557 03/28/2018 NBC NEWS

2018-256 01/09/2018 William Finlan
2018-2564 03/28/2018 Blue World Research Institute Inc

2018-2566 03/28/2018 FOIA GROUP INC
2018-2569 03/28/2018 Luis Figueredo Law LLC
2018-257 01/09/2018 William Coogan

2018-2572 03/28/2018 Extera Partners
2018-2573 03/28/2018 BUTTON LAW FIRM

2018-2574 03/28/2018 Randy Byrd LLC
2018-2575 03/28/2018 DAVIS WRIGHT TREMAINE LLP
2018-2576 03/28/2018 HALL, ANGELA
2018-2577 03/28/2018 KLUDT, TOM

2018-2578 03/28/2018 SOLLEY, MARY
2018-2579 03/28/2018 Doe J
2018-258 01/09/2018 WILEY REIN LLP

2018-2581 03/29/2018 Critchfield, Critchfield, & Johnston, Ltd.
2018-2582 03/29/2018 Az Institute for SPorts knees and shoulders
2018-2583 03/29/2018 MedTox Laboratories (LabCorp)

2018-2584 03/29/2018 ANDOLINA, VINCENT P
2018-2585 03/29/2018 WILSON ELSER ET AL
2018-2586 03/29/2018 StimLabs

2018-2587 03/29/2018 Aerin Medical Inc
2018-2589 03/29/2018 Human Xtensions Ltd.
2018-2590 03/29/2018 Huvepharma, Inc.
2018-2591 03/29/2018 Thomson Reuteres

2018-2592 03/29/2018 Morgan Stanley
2018-2593 03/30/2018 Brooke Raunig

2018-2595 04/02/2018 ET Now
2018-2596 04/02/2018 Dulari Batra

2018-26 01/02/2018 FOI Services, Inc.
2018-2600 04/02/2018 Aurelie MacDonald
2018-2601 04/02/2018 FDAAWARE
2018-2602 04/02/2018 Aurobindo Pharma USA Inc.
2018-2603 04/02/2018 STAT
2018-2604 04/02/2018 Prateek Goyal


2018-2610 04/02/2018 SAN FRANCISCO STATE UNIVERSITY
2018-2612 04/02/2018 Kelly A. Herczeg
2018-2613 04/02/2018 Doe J
2018-2614 04/02/2018 Goldeneye Seafood

2018-2617 04/02/2018 MedTech Review, LLC

2018-2618 04/02/2018 STAT
2018-2619 04/02/2018 Registrar Corp
2018-2620 04/02/2018 Baker Botts L.L.P.
2018-2621 04/02/2018 Baker Botts L.L.P.
2018-2622 04/02/2018 Axis Capital
2018-2623 04/02/2018 Nirsum Pharmaceuticals LLC
2018-2624 04/02/2018 Gland Pharma Limited
2018-2625 04/02/2018 Baker Botts L.L.P.
2018-2626 04/02/2018 Norwich Clinical Services Pvt Ltd

2018-2627 04/02/2018 Baker Botts L.L.P.
2018-2628 04/02/2018 Baker Botts L.L.P.
2018-2629 04/02/2018 Baker Botts L.L.P.
2018-2630 04/02/2018 Toronto Star
2018-2631 04/02/2018 Tel Aviv University

2018-2632 04/02/2018 Toronto Star
2018-2633 04/02/2018 Toronto Star
2018-2634 04/02/2018 FOIA GROUP INC
2018-2635 04/02/2018 FOIA GROUP INC
2018-2636 04/02/2018 Toronto Star
2018-2637 04/02/2018 david powell
2018-2639 04/02/2018 We R Food Safety!™



2018-2644 04/02/2018 Patternson Belknap

2018-2649 04/02/2018 ZOLL Manufacturing Corporation
2018-2652 04/02/2018 KeraLink West - Los Angeles
2018-2653 04/02/2018 Toronto Star


2018-2665 04/02/2018 FOI Services, Inc.
2018-2666 04/02/2018 FOI Services, Inc.
2018-2667 04/02/2018 FOI Services, Inc.
2018-2668 04/02/2018 FOI Services, Inc.
2018-2669 04/02/2018 FOI Services, Inc.
2018-2670 04/02/2018 FOI Services, Inc.

2018-2686 04/03/2018 GORDON & REES LLP
2018-2687 04/03/2018 NETWORKS 2000

2018-2688 04/03/2018 Doe J
2018-2689 04/03/2018 PEPPER LAW FIRM
2018-269 01/09/2018 SB OFFICE SUPPLIES
2018-2691 04/03/2018 ATKINSON, CHRIS
2018-2692 04/03/2018 DAVIS WRIGHT TREAMAINE LLP
2018-2693 04/03/2018 FOI Services, Inc.
2018-2694 04/03/2018 SAEN

2018-2695 04/03/2018 Techcyte, Inc.
2018-2697 04/03/2018 Jose Sanchez
2018-2698 04/03/2018 William McKenna
2018-2699 04/03/2018 FOI Services, Inc.

2018-27 01/02/2018 FOI Services, Inc.
2018-270 01/09/2018 Red Gold
2018-2700 04/03/2018 FOI Services, Inc.

2018-2701 04/03/2018 Doe J
2018-2702 04/03/2018 Bloomberg Quint
2018-2704 04/03/2018 Synaptive Medical
2018-2705 04/03/2018 William Coogan - CARA Therapeutics

2018-2707 04/03/2018 Nipro PharmaPackaging France
2018-2708 04/03/2018 FOI Services, Inc.
2018-2709 04/03/2018 FOI Services, Inc.

2018-271 01/09/2018 Microsoft Corporation
2018-2710 04/03/2018 DELPOR INC
2018-2711 04/03/2018 BIO-RAD LABORATORIES, INC.
2018-2712 04/03/2018 ABI DOCUMENT SUPPORT SERVICES
2018-2713 04/03/2018 Advantage Sales & Marketing LLC
2018-2714 04/03/2018 Bimeda, Inc.
2018-2715 04/03/2018 Prateek Goyal

2018-2716 04/03/2018 Rocket Medical Plc
2018-2717 04/03/2018 CREDIT SUISSE
2018-2718 04/03/2018 RBC
2018-2719 04/03/2018 TELEFLEX MEDICAL
2018-272 01/09/2018 FOLEY, BARON, METZGER & JUIP,P
2018-2720 04/03/2018 RIEDERS TRAVIS ET AL


2018-2724 04/03/2018 KENNY, CHRISTOPHER
2018-2725 04/03/2018 Kleinfeld Kaplan & Becker LLP
2018-2726 04/03/2018 Doe J
2018-2727 04/03/2018 RBC CAPITAL MARKETS
2018-2728 04/04/2018 University of Munich, Campus Großhadern
2018-2729 04/04/2018 Dulari Batra
2018-2730 04/04/2018 FOI Services, Inc.
2018-2731 04/04/2018 PROMISEMED HANGZHOU MEDITECH CO.,LTD.

2018-2732 04/04/2018 Neekul Desai
2018-2733 04/04/2018 Williams Acosta, PLLC

2018-2734 04/04/2018 STI Pharma LLC
2018-2735 04/04/2018 Arlene Tessitore
2018-2736 04/04/2018 FOI Services, Inc.

2018-2738 04/04/2018 Merck and Co., Inc.
2018-2739 04/04/2018 Nimble Co LLC
2018-2741 04/04/2018 Camargo Pharmaceutical Services
2018-2742 04/04/2018 BLOOMBERG NEWS

2018-2743 04/04/2018 FOI Services, Inc.
2018-2744 04/04/2018 Deven Sanon



2018-2757 04/04/2018 Insys Therapeutics, Inc.
2018-2759 04/04/2018 FDAAWARE

Yale Collaboration for Research Integrity and
2018-2761 04/04/2018 Transparency
2018-2762 04/04/2018 FOIA GROUP INC
2018-2763 04/04/2018 FOIA GROUP INC
2018-2764 04/04/2018 Terumo BCT, Inc.
2018-2765 04/04/2018 Doe J
2018-2771 04/04/2018 The Detroit News

2018-2772 04/04/2018 Endotec,inc
2018-2775 04/04/2018 KING & SPALDING

2018-2779 04/04/2018 Kathryn Becker
2018-278 01/09/2018 FOI Services, Inc.
2018-2780 04/04/2018 emids Technologies
2018-2781 04/04/2018 FOI Services, Inc.
2018-2782 04/04/2018 PFIZER INC
2018-2783 04/04/2018 Registrar Corp
2018-2784 04/04/2018 Heyer Regulatory Solutions LLC
2018-2785 04/04/2018 FOI Services, Inc.
2018-2787 04/04/2018 FOI Services, Inc.

2018-2788 04/04/2018 Melissa Stonerook
2018-2789 04/04/2018 Aly Karim

2018-279 01/09/2018 FDA NEWS
2018-2790 04/04/2018 Faruqi & Faruqi, LLP

2018-2791 04/04/2018 UNIVERSITY OF CALIFORNIA LOS ANGELES
2018-2792 04/04/2018 ET Now
2018-2795 04/04/2018 Nicholas Bednar

2018-2796 04/04/2018 PURDUE PHARMA L.P.
2018-2797 04/04/2018 PPTA
2018-2798 04/04/2018 Mentis Law Group
2018-2799 04/04/2018 CHARLOTTE CENTER FOR LEGAL ADVOCACY

2018-28 01/02/2018 FOI Services, Inc.
2018-2800 04/04/2018 JEWEL 42315-424, WILLIAM
2018-2801 04/04/2018 MULLER BRAZIL LLP
2018-2803 04/05/2018 Choncy W. Jones

2018-2804 04/05/2018 THE NEW YORK TIMES

2018-2806 04/05/2018 FDAZILLA
2018-2807 04/05/2018 Pink Sheet/Informa Business Intelligence

2018-2811 04/05/2018 Riley Smith

2018-2812 04/05/2018 ET Now
2018-2813 04/05/2018 Glenmark Pharmaceuticals Inc. USA
2018-2814 04/05/2018 Debra Bennett
2018-2815 04/05/2018 Debra Bennett

2018-2818 04/05/2018 PROPUBLICA
2018-2819 04/05/2018 Scovern Law

2018-2822 04/05/2018 Radius Health

2018-2825 04/05/2018 Carestream Health, Inc.
2018-2826 04/05/2018 FOIA GROUP INC
2018-2827 04/05/2018 Burel Pharmaceuticals, Inc.

2018-2828 04/05/2018 Water Jel Technologies, L.L.C.
2018-2829 04/05/2018 KILPATRICK, GREGORY
2018-2830 04/05/2018 WERTH T76856, MICHAEL
2018-2831 04/05/2018 ZUSMER, JOANNE
2018-2832 04/05/2018 JEANFREAU & JEANFREAU LLC
2018-2833 04/05/2018 LEE, FRANK
2018-2834 04/05/2018 ATKINSON, CHRISTOPHER
2018-2835 04/06/2018 Michael Garth Moore
2018-2836 04/06/2018 Simas, Sharon

2018-2838 04/06/2018 Registrar Corp
2018-2839 04/06/2018 Registrar Corp
2018-2840 04/06/2018 Registrar Corp
2018-2841 04/06/2018 Denton Intellectual Property Law Firm, LLC

2018-2843 04/06/2018 Golden eye seafood
2018-2844 04/06/2018 Anthony Ventrella

2018-2845 04/06/2018 Cannon Asset Management
2018-2846 04/06/2018 Srinivas Gurram
2018-2848 04/06/2018 Ichorion Ventures LLC
2018-2849 04/06/2018 Dow Corning Corporation

2018-285 01/09/2018 FOI Services, Inc.
2018-2850 04/06/2018 Jane Flasch
2018-2851 04/06/2018 CAM
Baylor College of Medicine/Texas Children's

2018-2852 04/09/2018 Hospital
2018-2854 04/09/2018 Campos Brothers Farms

2018-2855 04/09/2018 Wandercraft
2018-2857 04/09/2018 ROCHE DIAGNOSTICS
2018-2858 04/09/2018 Meijer Corp.

2018-2859 04/09/2018 CHF Solutions, Inc.
2018-286 01/09/2018 FDA NEWS
2018-2860 04/09/2018 Eminence Capital
2018-2861 04/09/2018 US Compounding, Inc.

2018-2862 04/09/2018 US Compounding, Inc.
2018-2863 04/09/2018 Anthony Ventrella

2018-2864 04/09/2018 ET Now

2018-2866 04/09/2018 Private Limited
2018-2868 04/09/2018 Elite Laboratories, Inc.
2018-2869 04/09/2018 PharmaCompany, Inc

2018-2870 04/09/2018 CSL Plasma, Inc.

2018-2872 04/09/2018 Advyzom
2018-2873 04/09/2018 Gordon + Holmes
2018-2874 04/09/2018 Encore Medical, L.P.
2018-2875 04/09/2018 Encore Medical, L.P.
2018-2877 04/09/2018 MILLENNIUM DENTAL TECHNOLOGIES INC

2018-2878 04/09/2018 AstaReal
2018-2879 04/09/2018 Strata Oncology
2018-288 01/09/2018 FOI Services, Inc.
2018-2880 04/09/2018 Osmotica Pharmaceutical
2018-2881 04/09/2018 Strata Oncology
2018-2882 04/09/2018 Advyzom
2018-2883 04/09/2018 ET Now
2018-2886 04/09/2018 Farm Market iD

2018-2890 04/09/2018 LENZE LAWYERS PLC
2018-2891 04/09/2018 DELEO #325903, DANIEL

2018-2892 04/09/2018 MALITO #241058, RALPH
2018-2894 04/09/2018 BOB'S SMOKIN' SOUTHERN BBQ LLC
2018-2895 04/09/2018 VANDERBES, JENNIFER

2018-2896 04/09/2018 Williams Kherkher Hart Boundas LLP
2018-2898 04/09/2018 Susan Devick
2018-2899 04/09/2018 FOI Services, Inc.

2018-29 01/02/2018 FOI Services, Inc.
2018-2900 04/09/2018 FOI Services, Inc.
2018-2901 04/09/2018 FOI Services, Inc.
2018-2902 04/09/2018 Registrar Corp
2018-2903 04/09/2018 DCCC

2018-2904 04/09/2018 Strata Oncology
2018-2906 04/09/2018 Cox Biosciences LLC
2018-2907 04/09/2018 MORTON GROVE PHARMACEUTICALS INC
2018-2910 04/09/2018 CITADEL LLC
2018-2911 04/09/2018 FDAAWARE
2018-2912 04/09/2018 Tornier, Inc.

2018-2917 04/10/2018 FDAZILLA
2018-2918 04/10/2018 - None -
2018-2919 04/10/2018 Cerium Pharmaceuticals, Inc.

2018-2920 04/10/2018 Infraredx, Inc.

2018-2922 04/10/2018 Ethicon
2018-2923 04/10/2018 Cantrell Drug Company
2018-2924 04/10/2018 ENDOTEC INC.
2018-2925 04/10/2018 Colgate, Edward
2018-2926 04/10/2018 Colgate, Edward
2018-2927 04/10/2018 STAT

2018-2928 04/10/2018 FOIA GROUP INC
2018-2929 04/10/2018 Josephine M. Brinley
2018-2930 04/10/2018 Incisive Surgical, Inc.
2018-2931 04/10/2018 Verified Credentials Inc.
2018-2932 04/10/2018 FDAAWARE
2018-2933 04/10/2018 SCIENCE MAGAZINE
2018-2934 04/10/2018 Applied Medical Resources Corporation

2018-2936 04/10/2018 MEDTRONIC
2018-2937 04/10/2018 FOI Services, Inc.
2018-2938 04/10/2018 FOI Services, Inc.
2018-2939 04/10/2018 FOI Services, Inc.
2018-294 01/09/2018 FOI Services, Inc.
2018-2940 04/10/2018 FOI Services, Inc.
2018-2941 04/10/2018 Melanie Mann
2018-2943 04/10/2018 FOI Services, Inc.
Federal Public Defender Office Middle District of
2018-2945 04/10/2018 Tennessee

2018-2947 04/10/2018 Chad Miller
2018-2948 04/10/2018 WALL STREET JOURNAL
2018-2949 04/10/2018 BLOOMBERG NEWS

2018-2950 04/10/2018 Alvogen Group
2018-2951 04/10/2018 Registrar Corp

2018-2953 04/10/2018 FOI Services, Inc.
2018-2954 04/10/2018 FOI Services, Inc.
2018-2955 04/10/2018 Michael Manoni
2018-2957 04/10/2018 OLD DOMINION UNIVERSITY
2018-2958 04/10/2018 VENABLE LLP

2018-2960 04/10/2018 QUINN, TOM
2018-2961 04/10/2018 PERKINS COIE

2018-2962 04/10/2018 Ramsey, Ollie
2018-2964 04/11/2018 FDAAWARE
2018-2965 04/11/2018 FDAAWARE
2018-2966 04/11/2018 C.H. Robinson Worldwide, Inc.





2018-2981 04/11/2018 FOI Services, Inc.
2018-2984 04/11/2018 FOI Services, Inc.
2018-2985 04/11/2018 Regulatory Services Company, LLC
2018-2986 04/11/2018 Yale University
2018-2987 04/11/2018 David Changaris
2018-2988 04/11/2018 Steven Moran


2018-2994 04/11/2018 Cindy Rendl
2018-2995 04/11/2018 FDAZILLA
2018-2996 04/11/2018 FDAZILLA
2018-2997 04/11/2018 FDAZILLA
2018-2998 04/11/2018 FDAZILLA
2018-2999 04/11/2018 FDAZILLA

2018-3 01/02/2018 Mary Cedroni
2018-3000 04/11/2018 FDAZILLA
2018-3001 04/11/2018 FDAZILLA
2018-3002 04/11/2018 FDAZILLA

2018-3003 04/11/2018 BUTTON LAW FIRM
2018-3004 04/11/2018 WILLIAMS KHERKHER
2018-3005 04/11/2018 SYNTRON BIORESEARCH INC
2018-3006 04/11/2018 COCHRANE, SALLY
2018-3007 04/11/2018 JULES 411829-D2103, JEAN


2018-3010 04/11/2018 GROSSMAN & MOORE PLLC
2018-3011 04/11/2018 ABRAHAM FRUCHTER & TWERSKY LLP
2018-3012 04/11/2018 KITCH DRUTCHAS ET AL
2018-3013 04/11/2018 EDEN BRIDGE PHARMA
2018-3014 04/11/2018 UNIVERSITY OF KENTUCKY
2018-3016 04/11/2018 ROLL LAW GROUP PC
2018-3019 04/12/2018 Akerman LLP

2018-3021 04/12/2018 FOI Services, Inc.
2018-3022 04/12/2018 FOI Services, Inc.
2018-3023 04/12/2018 STAT


2018-3030 04/12/2018 FDAZILLA

2018-3031 04/12/2018 STAT


2018-3041 04/12/2018 Teva Pharmacovigilance

2018-3045 04/12/2018 Ironwood Pharmaceuticals, Inc.



2018-3050 04/12/2018 PFIZER, INC
2018-3051 04/12/2018 Medegen Medical Products, LLC

2018-3052 04/12/2018 FDANEWS
2018-3053 04/12/2018 UMN

2018-3055 04/12/2018 Rho, Inc.
2018-3057 04/12/2018 Medegen Medical Products, LLC
2018-3058 04/12/2018 Bashas' Inc.

2018-3060 04/12/2018 BEVERIDGE & DIAMOND

2018-3062 04/12/2018 Advanced Monitored Caregiving Inc.
2018-3063 04/12/2018 PROPUBLICA

2018-3066 04/12/2018 FOI Services, Inc.
2018-3067 04/12/2018 FOI Services, Inc.

2018-3068 04/13/2018 Biotrial Bioanalytical Services
2018-3069 04/13/2018 FDAZILLA

2018-307 01/10/2018 Kleinfeld Kaplan and Becker LLP
2018-3070 04/13/2018 TerraFree, LLC

2018-3072 04/13/2018 FROST BROWN TODD LLC
2018-3073 04/13/2018 Carlos Ramirez
2018-3075 04/13/2018 Michael Farbenblum

2018-3076 04/13/2018 Sorling Northrup

2018-3078 04/13/2018 OFW LAW
2018-3079 04/13/2018 OBI Pharma USA Inc.
2018-308 01/10/2018 FOI Services, Inc.

2018-3080 04/13/2018 Boston University

2018-3082 04/13/2018 PCCA
2018-3083 04/13/2018 Contract In-House Counsel and Consultants, LLC
2018-3084 04/13/2018 Akorn Pharmaceuticals, Inc.
2018-3085 04/13/2018 Yale University
2018-3087 04/13/2018 FOI Services, Inc.

2018-3088 04/13/2018 Kite Pharma
2018-3089 04/13/2018 J.P. Morgan India Pvt Ltd
2018-3090 04/13/2018 Prateek Goyal
2018-3091 04/13/2018 Guideline Solutions, Inc.
2018-3092 04/13/2018 Boston Children's Hospital/Harvard Medical School

2018-3093 04/13/2018 Hyprevention SAS
2018-3095 04/13/2018 Doe J

2018-3097 04/13/2018 Techcyte, Inc.
2018-3098 04/13/2018 FDAZILLA

2018-3099 04/13/2018 MedRhythms, Inc.
2018-31 01/02/2018 FOI Services, Inc.
2018-310 01/10/2018 Richard Hirsch

2018-3100 04/13/2018 Doe J
2018-3101 04/13/2018 MYLAN NV
2018-3102 04/13/2018 Doe J
2018-3103 04/13/2018 BIO-RAD LABORATORIES, INC.
2018-3104 04/13/2018 Harrington Films

2018-3105 04/13/2018 MedRhythms, Inc.
2018-3106 04/13/2018 Kool Blast Gas Inc
2018-3107 04/13/2018 Biocomposites Ltd
2018-3109 04/13/2018 Michelle Illig
2018-311 01/10/2018 Richard Hirsch
2018-3110 04/13/2018 FOI Services, Inc.
2018-3111 04/13/2018 FOI Services, Inc.
2018-3112 04/13/2018 FOI Services, Inc.
2018-3113 04/13/2018 FOI Services, Inc.
2018-3114 04/13/2018 FOI Services, Inc.
2018-3115 04/13/2018 FOI Services, Inc.
2018-3116 04/13/2018 FOI Services, Inc.

2018-3117 04/13/2018 FOI Services, Inc.
2018-3118 04/13/2018 Nature’s Rite, LLC
2018-312 01/10/2018 Ricardo Roig

2018-3120 04/16/2018 FOI Services, Inc.
2018-3121 04/16/2018 FOI Services, Inc.
2018-3125 04/16/2018 FOI Services, Inc.
2018-3129 04/16/2018 FOI Services, Inc.
2018-3131 04/16/2018 UNITEHERE!
2018-3132 04/16/2018 Philip G. Mylod, Esquire

2018-3133 04/16/2018 Maddy McCartney
2018-3134 04/16/2018 CTFN

2018-3135 04/16/2018 FOI Services, Inc.
University of California, San Francisco - School

2018-3136 04/16/2018 of Pharmacy
2018-314 01/10/2018 FDAAWARE

2018-3140 04/16/2018 FOI Services, Inc.
2018-3141 04/16/2018 Laurus Labs Limited
2018-3143 04/16/2018 Dr Ajay Phadke
2018-3145 04/16/2018 McCarthy, Leonard & Kaemmerer, LC
2018-3148 04/16/2018 Minsung Kang

2018-3149 04/16/2018 Minsung Kang
2018-3150 04/16/2018 Division Of Pharmacoepidemiology

FEDERAL DEFENDER SERVICES OF EASTERN TENNESSEE
2018-3156 04/16/2018 INC
2018-3157 04/16/2018 Intas Pharmaceuticals Limited
2018-3158 04/16/2018 FDA NEWS
2018-3161 04/16/2018 FOI Services, Inc.
Division of Pharmacoepidemiology and
2018-3163 04/16/2018 Pharmacoeconomics
2018-3164 04/16/2018 Hologic Corporation

2018-3166 04/16/2018 PIPER JAFFRAY & CO
2018-3169 04/17/2018 Martin J. Whitman School of Management

2018-317 01/10/2018 Ronald C. Blass, Jr.
2018-3170 04/17/2018 pradeep dondapati
2018-3171 04/17/2018 ROBBINS ARROYO LLP

2018-3174 04/17/2018 Womble Bond Dickinson
2018-3175 04/17/2018 PROPUBLICA
2018-3176 04/17/2018 LifeSan Clinical Research

2018-318 01/10/2018 Limacorporate Spa

2018-3181 04/17/2018 Jaclyn Leong, DO (University of Arizona)
2018-3183 04/17/2018 Heyer Regulatory Solutions LLC

2018-3185 04/17/2018 Kathleen G. Morris Attorney at Law
2018-3186 04/17/2018 Nicholson Science
2018-3187 04/17/2018 WHITE & CASE LLP

2018-3188 04/17/2018 OFW LAW
2018-3189 04/17/2018 Nano Precision Medical

2018-319 01/10/2018 oregon state university / OHSU
2018-3190 04/17/2018 Doe J
2018-3195 04/17/2018 LINCARE INC

2018-3196 04/17/2018 Doe J
2018-3199 04/17/2018 joeris, Leonard
2018-32 01/02/2018 FOI Services, Inc.
2018-320 01/10/2018 Kendra Jowers

2018-3200 04/17/2018 joeris, Leonard
2018-3201 04/17/2018 joeris, Leonard
2018-3202 04/17/2018 Doe J
2018-3203 04/17/2018 FRESCA MEDICAL
2018-3204 04/17/2018 KCBS-TV

2018-3205 04/17/2018 BIOPRO INC
2018-3207 04/17/2018 LENZ, TRACY

2018-3212 04/17/2018 UNIV OF WISCONSIN-MADISON
2018-3213 04/18/2018 FOOD SAFETY NEWS
2018-3214 04/18/2018 Thomas Busse

2018-3215 04/18/2018 Susan Devick
2018-3216 04/18/2018 Govzilla, Inc.

2018-3217 04/18/2018 Doe J
Duke University Office of Regulatory Affairs and
2018-3218 04/18/2018 Quality
2018-3219 04/18/2018 FOI Services, Inc.
2018-322 01/10/2018 Registrar Corp

2018-3220 04/18/2018 Steven Leung
2018-3222 04/18/2018 NTK Network

2018-3223 04/18/2018 Prateek Goyal
2018-3224 04/18/2018 Prateek Goyal

2018-3225 04/18/2018 SEYFARTH SHAW LLP
2018-3226 04/18/2018 SUNRISE MEDICAL
2018-3228 04/18/2018 FOI Services, Inc.
2018-3229 04/18/2018 Informa / Natural Products Insider
2018-323 01/10/2018 FDAZILLA

2018-3230 04/18/2018 Steven Leung
2018-3231 04/18/2018 Glendale Warehouse & Distribution Corp.
2018-3233 04/18/2018 Doe J
2018-3234 04/18/2018 Mari Yonomoto

2018-3235 04/18/2018 Jodi Ware
2018-3236 04/18/2018 Mari Yonomoto
2018-3237 04/18/2018 Mari Yonomoto

2018-324 01/11/2018 Jake Todd
2018-3242 04/18/2018 FDA NEWS
2018-3243 04/18/2018 FDA NEWS
2018-3244 04/18/2018 FDA NEWS
2018-3245 04/18/2018 FOI Services, Inc.
2018-3246 04/18/2018 FOI Services, Inc.
2018-3247 04/18/2018 FOI Services, Inc.
2018-325 01/11/2018 FDAZILLA

2018-3258 04/19/2018 Bartimus Frickleton Robertson Rader

2018-3259 04/19/2018 The Law Offices of Daniel Weltin
2018-326 01/11/2018 Sylvan Inc.

2018-3265 04/19/2018 Drug Quality Assurance, LLC

2018-3266 04/19/2018 Doe J

2018-327 01/11/2018 Jake Todd
2018-3270 04/19/2018 FDAZILLA
2018-3271 04/19/2018 Dulari Batra
2018-3272 04/19/2018 Bill Ardern
2018-3273 04/19/2018 FOI Services, Inc.
2018-3274 04/19/2018 Food Regulatory Guild

2018-3276 04/19/2018 Morgan Stanley Research
2018-3277 04/19/2018 CREDIT SUISSE
2018-3278 04/19/2018 Alicia Antiri
2018-3279 04/19/2018 Alicia Antiri

2018-328 01/11/2018 FDAble LLC
2018-3280 04/19/2018 Alicia Antiri

2018-3281 04/19/2018 BUTTON LAW FIRM
2018-3282 04/19/2018 CONYERS GA5328, DWAYNE
2018-3284 04/19/2018 LENZ, TRACY

2018-3286 04/19/2018 HOME ACCESS HEALTH CORP
2018-3287 04/19/2018 Doe J

2018-3289 04/19/2018 Biological E Limited
2018-3290 04/19/2018 MUCKROCK NEWS

2018-3296 04/20/2018 ET Now


2018-33 01/02/2018 FOI Services, Inc.
2018-330 01/11/2018 FDAZILLA

2018-3300 04/20/2018 Doe J
2018-3301 04/20/2018 Aaron Rose
2018-3302 04/20/2018 FDAZILLA

2018-3304 04/20/2018 Yukevich Cavanaugh
2018-3305 04/20/2018 FOI Services, Inc.
2018-3306 04/20/2018 Kazan, McClain, et al

2018-3307 04/20/2018 FOI Services, Inc.
HSBC Securities and Capital Markets (India)
2018-3309 04/20/2018 Private Limited

2018-3310 04/20/2018 Bradley A. MacLean Attorney at Law

2018-3312 04/20/2018 Rawl Law Group

2018-3314 04/20/2018 Bryan Cave Leighton Paisner LLP
2018-3315 04/20/2018 Prateek Goyal

2018-3317 04/20/2018 BLOOMBERG NEWS
2018-3318 04/20/2018 Ram Iyer
2018-3319 04/20/2018 ALLTECH, INC.

2018-3320 04/23/2018 Doe J

2018-3322 04/23/2018 FOIA GROUP INC
2018-3323 04/23/2018 Craig Watson
2018-3324 04/23/2018 Rawl Law Group
2018-3325 04/23/2018 A&Z Pharmaceutical Inc.
2018-3326 04/23/2018 The Dartmouth Institute Ctr for Med and Media

2018-3329 04/23/2018 FOIA GROUP INC
2018-3330 04/23/2018 Mintz Levin Cohn Ferris Glovsky and Popeo, PC

2018-3331 04/23/2018 Graziella Madeo
2018-3332 04/23/2018 Education for All
2018-3333 04/23/2018 Penny Catanzariti

2018-3335 04/23/2018 Pink Sheet/Informa Business Intelligence
2018-3336 04/23/2018 Teresa Hayes
2018-3337 04/23/2018 Doe J

2018-3338 04/23/2018 Kashiv pharma LLC
2018-3339 04/23/2018 Stephanie Scarton
2018-334 01/11/2018 HARVARD BUSINESS SCHOOL
2018-3340 04/23/2018 Midlink International Inc
2018-3341 04/23/2018 Wong, Wong & Associates, P.C.
2018-3342 04/23/2018 Sun Chlorella USA Corp.

2018-3344 04/23/2018 Eton Pharmaceuticals, Inc
2018-3345 04/23/2018 FOIA GROUP INC
2018-3346 04/23/2018 Internacional Farmaceutica
2018-3347 04/23/2018 VEGE KURL, INC.
2018-335 01/11/2018 Marc J. Bern & Partners LLP
2018-3350 04/23/2018 Division Of Pharmacoepidemiology
University of Missouri Kansas City School of
2018-3351 04/23/2018 Pharmacy Drug Informaiton Center
2018-3353 04/23/2018 CardioRenal

2018-3354 04/23/2018 FDAAWARE
2018-3356 04/23/2018 NAVIGANT CONSULTING
2018-3357 04/23/2018 Minsung Kang
2018-3359 04/23/2018 Tel Aviv University
2018-336 01/11/2018 jonathan sackner-bernstein
2018-3360 04/23/2018 OFW LAW
2018-3361 04/24/2018 NBC NEWS
2018-3362 04/24/2018 OFW LAW
2018-3363 04/24/2018 MPG Operations LLC

2018-3364 04/24/2018 Doe J
2018-3365 04/24/2018 TROUTMAN SANDERS LLP
2018-3366 04/24/2018 OFW LAW

2018-3367 04/24/2018 QARA Consulting Group

2018-337 01/11/2018 Marc J. Bern & Partners LLP

2018-3376 04/24/2018 Private Limited
2018-3379 04/24/2018 CEUTICAL LABORATORIES INC.
2018-3380 04/24/2018 CARPENTER LIPPS & LELAND LLP

2018-3382 04/24/2018 Accelerate Diagnostics, Inc.
2018-3384 04/24/2018 Huvepharma, Inc.

2018-3385 04/24/2018 FOI Services, Inc.
2018-3386 04/24/2018 Claria Medical
2018-3387 04/24/2018 DETAX GMBH & CO KG

2018-3388 04/24/2018 FOI Services, Inc.
2018-3390 04/24/2018 Zac Johnson
2018-3391 04/24/2018 David Horn
2018-3392 04/24/2018 Alvogen Group
2018-3393 04/24/2018 Andrew Hess

2018-3395 04/24/2018 Fresenius Kabi USA LLC
2018-3396 04/24/2018 Preferred Regulatory Consulting Inc.
2018-3397 04/24/2018 Registrar Corp
2018-3398 04/24/2018 The Dominion Post
2018-3399 04/24/2018 TAULER SMITH LLP

2018-34 01/02/2018 FOI Services, Inc.
2018-340 01/11/2018 FOI Services, Inc.
2018-3401 04/24/2018 HAWKINS PARNELL THACKSTON & YOUNG LLP
2018-3402 04/24/2018 ZUSMER, JOANNE

2018-3404 04/24/2018 KCBS-TV

2018-3406 04/24/2018 IsoAid LLC

2018-3408 04/24/2018 ANTIRI, ALICIA
2018-3409 04/24/2018 ANTIRI, ALICIA
2018-341 01/11/2018 FOI Services, Inc.
2018-3410 04/25/2018 ENDOTEC
2018-3411 04/25/2018 FOIA GROUP INC

2018-3413 04/25/2018 Kowa Company, Ltd.

2018-3415 04/25/2018 TLC Therapeutics, LLC
2018-3416 04/25/2018 John DeBeer
2018-3417 04/25/2018 Susan Devick
2018-3418 04/25/2018 Kaufman Dolowich Voluck & Gonzo LLP

2018-342 01/11/2018 Healthco. Research, LLC
2018-3420 04/25/2018 KARL STORZ ENDOSCOPY AMERICA INC
2018-3421 04/25/2018 KARL STORZ ENDOSCOPY AMERICA INC

2018-3422 04/25/2018 Doe J
2018-3423 04/25/2018 FDA NEWS
2018-3424 04/25/2018 FDA NEWS
2018-3425 04/25/2018 FDA NEWS
2018-3426 04/25/2018 FOI Services, Inc.

2018-3427 04/25/2018 FDA NEWS
2018-3428 04/25/2018 FDA NEWS
2018-3429 04/25/2018 FDA NEWS
2018-343 01/11/2018 FOI Services, Inc.
2018-3430 04/25/2018 FDA NEWS
2018-3431 04/25/2018 FDA NEWS
2018-3432 04/25/2018 FDA NEWS
2018-3433 04/25/2018 FDA NEWS
2018-3434 04/25/2018 FDA NEWS

2018-3435 04/25/2018 University of Campania
2018-3437 04/25/2018 Microgenics Corporation
2018-3438 04/25/2018 WuXi AppTec Inc.
2018-3439 04/25/2018 Registrar Corp

2018-344 01/11/2018 FOI Services, Inc.
2018-3440 04/25/2018 PHYSIO-CONTROL, INC.
2018-3441 04/25/2018 Fosun Pharma USA Inc.
2018-3442 04/25/2018 Software Platform Consulting Inc.

2018-3443 04/25/2018 Ethicon, Inc. (c/o O'Melveny & Myers)

2018-3446 04/25/2018 FDAAWARE
2018-3447 04/25/2018 FDA NEWS
2018-3448 04/25/2018 FDA NEWS

2018-3449 04/25/2018 FDA NEWS
2018-345 01/11/2018 LEVIN PAPANTONIO ET AL

2018-3450 04/25/2018 FDA NEWS
2018-3451 04/25/2018 FDA NEWS
2018-3452 04/25/2018 FDA NEWS
2018-3453 04/25/2018 Liberum Capital Limited

2018-3454 04/25/2018 SECHRIST INDUSTRIES INC
2018-3455 04/25/2018 Children's Hospital of Pennsylvania
2018-3456 04/25/2018 FDA NEWS
2018-3457 04/25/2018 FDA NEWS
2018-3458 04/25/2018 FDA NEWS
2018-3459 04/25/2018 UC Irvine Dermatology Research Center
2018-3460 04/25/2018 Suzanne Allmart
2018-3461 04/25/2018 Suzanne Allmart

2018-3462 04/25/2018 Institute of Pharmacy, Nirma University
2018-3463 04/25/2018 POLYSCOPE POLYMERS BV
2018-3466 04/25/2018 Emkay Global

2018-3468 04/25/2018 Kimber Price
2018-3469 04/25/2018 Mylan Laboratories Limited, India
2018-347 01/11/2018 Doe J
2018-3470 04/25/2018 Pelorus Jack Capital
2018-3472 04/25/2018 Dr Ajay Phadke
2018-3474 04/25/2018 Auroliofe Pharma LLC
2018-3475 04/25/2018 Kettle Hill Capital
2018-3476 04/25/2018 ZAB 129341, CODY ALLEN
INTERNATIONAL CONSORTIUM OF INVESTIGATIVE
2018-3477 04/25/2018 JOURNALISTS
2018-3478 04/25/2018 ROBBINS GELLER ET AL

2018-348 01/11/2018 UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN
2018-3481 04/25/2018 POTTS LAW FIRM LLC
2018-3483 04/26/2018 John Jay College of Criminal Justice

2018-3484 04/26/2018 Rawl Law Group
2018-3485 04/26/2018 MIAMI HERALD

2018-3487 04/26/2018 Colibri Partners Inc.
2018-3488 04/26/2018 BALLARD SPAHR LLP
2018-3489 04/26/2018 QIAGEN Sciences LLC
2018-349 01/11/2018 FORNATORO, KELLEY

2018-3490 04/26/2018 FOIA GROUP INC
2018-3491 04/26/2018 Vascular Solutions, Inc.
2018-3492 04/27/2018 FOIA GROUP INC
2018-3496 04/27/2018 Laurie Martin

2018-3497 04/27/2018 Pathway Communications
2018-3498 04/27/2018 Pathway Communications
2018-3499 04/27/2018 Bühler AG

2018-3500 04/27/2018 Toshio Murata
2018-3501 04/27/2018 OFW LAW
2018-3502 04/27/2018 ET Now
2018-3504 04/27/2018 Kimberly Buchanan

2018-3506 04/27/2018 Microgenics Corporation
2018-3507 04/27/2018 Dr Ajay Phadke
2018-3508 04/27/2018 KC Pharmaceuticals, Inc

2018-3509 04/27/2018 BOSTON SCIENTIFIC
2018-351 01/11/2018 MUCKROCK NEWS
2018-3510 04/27/2018 Sovereign Pharmaceuticals, LLC
2018-3511 04/30/2018 OFW LAW

2018-3512 04/30/2018 Govzilla, Inc.

2018-3514 04/30/2018 Arrow International, Inc.
2018-3515 04/30/2018 The Alpha Bio Group, LLC
2018-3516 04/30/2018 BLOOMBERG NEWS
2018-3517 04/30/2018 Chleborowicz Law Firm, PLLC
2018-3518 04/30/2018 Lewis & Harrison LLC
2018-3519 04/30/2018 FOIA GROUP INC
2018-3522 05/01/2018 Virbac Corp
2018-3523 05/01/2018 Chu, Linh
2018-3524 05/01/2018 THOMSON REUTERS

2018-3525 05/01/2018 PROPUBLICA
2018-3526 05/01/2018 Registrar Corp
2018-3527 05/01/2018 FOI Services, Inc.
2018-3528 05/01/2018 Indiana University Health

2018-353 01/11/2018 HUNTON & WILLIAMS LLP
2018-3532 05/01/2018 DCM

2018-3533 05/01/2018 BRIGHT Research Partners
2018-3534 05/01/2018 Clark Hill PLLC
2018-3535 05/01/2018 Riconpharma LLC
2018-3536 05/01/2018 NBC NEWS

2018-3537 05/01/2018 Grant & Eisenhofer P.A.
2018-3538 05/01/2018 Neurolixis Inc.
2018-3539 05/01/2018 Clark Hill PLLC
2018-354 01/11/2018 LINCARE INC

2018-3540 05/01/2018 Waverley Pharma Inc
2018-3542 05/01/2018 Areva Pharmaceuticals
2018-3543 05/01/2018 Cincinnati Sub Zero Products, LLC
2018-3544 05/01/2018 Argon Medical Devices, Inc.
2018-3545 05/01/2018 ARTHREX, INC.
2018-3548 05/01/2018 Wellington Foods, Inc

2018-355 01/11/2018 LINCARE INC
2018-3550 05/01/2018 PL DEVELOPMENTS
2018-3551 05/01/2018 Frank Mowry
2018-3552 05/01/2018 Jefferies India
2018-3553 05/01/2018 PITTSBURGH POST-GAZETTE

2018-3554 05/01/2018 Raymond James
2018-3556 05/01/2018 ARTHREX, INC.

2018-356 01/11/2018 LINCARE INC

2018-3561 05/01/2018 FOI Services, Inc.
2018-3562 05/01/2018 Ohio State University
2018-3563 05/01/2018 Graeme Ladds

2018-3565 05/01/2018 Kline & Company

2018-3567 05/01/2018 CONSUMER HEALTHCARE PRODUCTS ASSOCIATION
2018-3568 05/01/2018 PHARMICHEM TESTING SERVICES INC
2018-3569 05/01/2018 STOTTER & ASSOCIATES LLC
2018-357 01/11/2018 LINCARE INC

2018-3570 05/01/2018 Fluoresprobe Sciences, LLC.
2018-3571 05/01/2018 O'MELVENY & MYERS LLP

2018-3573 05/01/2018 GRANATO, ANDREW
2018-3574 05/01/2018 JUDICIAL WATCH
2018-3575 05/01/2018 JUDICIAL WATCH
2018-3576 05/01/2018 Roth, Steven
2018-3577 05/01/2018 XTTRIUM LABORATORIES INC

2018-3578 05/01/2018 SUPERNUS PHARMACEUTICALS INC
2018-3579 05/01/2018 DCCC
2018-358 01/11/2018 MUCKROCK NEWS
2018-3580 05/01/2018 WJLA ABC7
2018-3581 05/01/2018 JACKSON, RICHARD
2018-3582 05/01/2018 ARNALL GOLDEN GREGORY LLP
2018-3583 05/01/2018 LACHMAN CONSULTANT SERVICES INC

2018-3584 05/02/2018 Shagun Singh
2018-3586 05/02/2018 RBC

2018-359 01/11/2018 HuffPost


2018-3598 05/02/2018 Doe J
2018-3599 05/02/2018 Dr Ajay Phadke
2018-36 01/02/2018 University of Texas at Tyler
2018-360 01/11/2018 HUMAN RIGHTS DEFENSE CENTER
2018-3600 05/02/2018 Kite Pharma, Inc.
2018-3601 05/02/2018 Ovid Therapeutics
2018-3602 05/02/2018 JP MORGAN

2018-3605 05/02/2018 FOI Services, Inc.
2018-3606 05/02/2018 Apollo Care, LLC

2018-3608 05/02/2018 PACIRA Pharmaceuticals, Inc.

2018-3609 05/02/2018 Jim Morris
2018-361 01/11/2018 MISSOURI STATE PUBLIC DEFENDER SYSTEM
2018-3610 05/02/2018 MEDIcept, Inc.
2018-3611 05/02/2018 Helser, Judy
Düsseldorf Institute for Competition Economics
2018-3612 05/02/2018 (DICE)
2018-3613 05/02/2018 PROPUBLICA

2018-3615 05/02/2018 Piper Labs
2018-3616 05/02/2018 Onkos Surgical
Liquid Herbals Manufacturing, LLC dba Liquid
2018-3617 05/02/2018 Nutra Group
2018-3618 05/02/2018 FDAAWARE
2018-3619 05/02/2018 Parexel International
2018-362 01/11/2018 STATE LICENSING SERVICING INC
2018-3620 05/02/2018 Magnetar Capital
2018-3621 05/02/2018 FDAZILLA

2018-3622 05/02/2018 COREPHARMA LLC
Collaboration for Research Integrity &

2018-3623 05/02/2018 Transparency
2018-3626 05/02/2018 Emilia Pricton

2018-3627 05/02/2018 Registrar Corp
2018-3628 05/02/2018 FOIA GROUP INC
2018-3629 05/02/2018 Pac-Dent, Inc.

2018-3631 05/02/2018 Andersen Sleater Sianni LLC

2018-3635 05/02/2018 CHARLES RIVER
2018-3636 05/02/2018 CHARLES RIVER
2018-3637 05/02/2018 CHARLES RIVER
2018-3638 05/02/2018 CHARLES RIVER
2018-3639 05/02/2018 CHARLES RIVER
2018-364 01/11/2018 JOJENE MILLS PC
2018-3640 05/02/2018 Gordon and Rees LLP
2018-3643 05/02/2018 C HUMPHREY & ASSOCS PA
2018-3644 05/02/2018 DCCC
2018-3645 05/02/2018 ALDER LAW PC
2018-3646 05/02/2018 ZAB 129341, CODY ALLEN
2018-3647 05/02/2018 Doe J
2018-3648 05/02/2018 Doe J
Collaboration for Research Integrity &
2018-3649 05/03/2018 Transparency
2018-365 01/12/2018 THOMSON REUTERS
2018-3650 05/03/2018 Troutman Sanders, LLP

2018-3651 05/03/2018 Icahn School of Medicine at Mt. Sinai
2018-3652 05/03/2018 FOI Services, Inc.
2018-3653 05/03/2018 WILEY REIN LLP
2018-3654 05/03/2018 Pascal Couture
2018-3655 05/03/2018 Mitchell Cancer Institute, Univ South Alabama
2018-3656 05/03/2018 NTK Network
2018-3657 05/03/2018 Pascal Couture

2018-3658 05/03/2018 Sugarpod Naturals
2018-3659 05/03/2018 FiercePharma
2018-366 01/12/2018 DEKA R&D
2018-3660 05/03/2018 FDAAWARE

2018-3661 05/03/2018 FDAAWARE
2018-3662 05/03/2018 KNOWLEDGE ECOLOGY INTERNATIONAL
2018-3663 05/03/2018 Central Penn College
2018-3664 05/03/2018 Bridgewaters Salon & Spa

2018-3665 05/03/2018 FRIENDS OF THE EARTH
2018-367 01/12/2018 Brian McCarter

2018-3670 05/03/2018 EMORD & ASSOCIATES, P.C.
2018-3671 05/03/2018 STRATEGIC PACING SYSTEMS LLC
2018-3672 05/03/2018 HUFFINGTON POST

2018-3674 05/04/2018 Northgate Supermarket
2018-3675 05/04/2018 The Dartmouth Institute Ctr for Med and Media
2018-3676 05/04/2018 The Myerson Company Limited
2018-3677 05/04/2018 Doe J
2018-3678 05/04/2018 FOI Services, Inc.
2018-3679 05/04/2018 Prosolus, Inc.
2018-368 01/12/2018 Emmanuel Filandrianos

2018-3680 05/04/2018 BRISTOL-MYERS SQUIBB
2018-3682 05/04/2018 St. Jude Medical (Abbott)
2018-3683 05/04/2018 Senvest Management LLC

2018-3684 05/04/2018 FOI Services, Inc.
Max Planck Institute for Mathematics in the
2018-3686 05/04/2018 Sciences
2018-3687 05/04/2018 Walgreen Co.
2018-3688 05/04/2018 FDAZILLA

2018-369 01/12/2018 Nokia Digital Health
2018-3690 05/04/2018 GREENBERG TRAURIG

2018-3692 05/04/2018 TODD & WELD LLP
2018-3693 05/04/2018 LONGO, ANDREA FRANCESCO

2018-3694 05/04/2018 THEDEVICEDR.COM
2018-3695 05/07/2018 Elevation Brands LLC

2018-3696 05/07/2018 BioVera Inc.
2018-3698 05/07/2018 Kowa Company, Ltd.
2018-3699 05/07/2018 Doe J
2018-3705 05/07/2018 FOIA GROUP INC
2018-3706 05/07/2018 FOIA GROUP INC
2018-3707 05/07/2018 Medical Technology Research Inc

2018-3708 05/07/2018 Chris Cerbone
2018-3709 05/07/2018 FOI Services, Inc.
2018-371 01/12/2018 LIFE EXTENSION

2018-3710 05/07/2018 FOIA GROUP INC
2018-3712 05/07/2018 Sorling Northrup

2018-3713 05/07/2018 Vicarious Surgical
2018-3715 05/07/2018 WuXi AppTec Inc.
2018-3716 05/07/2018 Zimmer Biomet
2018-3717 05/07/2018 WuXi AppTec Inc.

2018-3718 05/07/2018 ABC NEWS
2018-3719 05/07/2018 WICKER SMITH ET AL
2018-372 01/12/2018 LIFE EXTENSION

2018-3720 05/07/2018 Academic medical center Amsterdam
2018-3721 05/07/2018 WASHINGTON POST
2018-3722 05/07/2018 WASHINGTON POST
2018-3724 05/07/2018 Susquehanna Financial Group (SIG)

2018-3727 05/07/2018 Salmon River Foods Inc.

2018-3728 05/07/2018 FOI Services, Inc.
2018-3729 05/07/2018 FOI Services, Inc.
2018-373 01/12/2018 Derek Baggett
2018-3733 05/07/2018 FOI Services, Inc.
2018-3738 05/07/2018 MOUND COTTON ET AL


2018-3741 05/07/2018 ROCKY MOUNTAIN POISON DRUG CTR
2018-3742 05/08/2018 Maridalia Torres
2018-3743 05/08/2018 Marjon Specialty Foods, Inc
2018-3745 05/08/2018 Schlesinger Law Offices, P.A.

2018-3746 05/08/2018 ARTHREX, INC.
2018-3747 05/08/2018 BakeryandSnacks.com
2018-3748 05/08/2018 Neutrolis Therapeutics Inc

2018-3750 05/08/2018 Buzzfeed News
2018-3751 05/08/2018 Birth Tissue Recovery
2018-3752 05/08/2018 Surbhi Prashikshan Sansthan Maryadit

2018-3754 05/08/2018 Actial Farmaceutica
2018-3755 05/08/2018 ALSTON & BIRD

2018-3756 05/08/2018 Art Chep
2018-3758 05/08/2018 D Sanon
2018-3759 05/08/2018 D Sanon
2018-376 01/12/2018 FOI Services, Inc.
2018-3760 05/08/2018 D Sanon
2018-3761 05/08/2018 Axis Capital

2018-3762 05/08/2018 Capote Law Firm
2018-3763 05/08/2018 Baxalta US Inc.
2018-3764 05/08/2018 DHC AG
2018-3766 05/08/2018 D Sanon
2018-3767 05/08/2018 Registrar Corp
2018-3768 05/08/2018 FOOD SAFETY NEWS

2018-3769 05/08/2018 Dr Ajay Phadke
2018-377 01/12/2018 ABBOTT POINT OF CARE INC
2018-3770 05/08/2018 NTK Network

2018-3771 05/08/2018 FOI Services, Inc.
2018-3772 05/08/2018 Registrar Corp
2018-3773 05/08/2018 Ascend Laboratories,llc
2018-3774 05/08/2018 UNIVERSITY OF MINNESOTA

2018-3775 05/08/2018 ET Now
2018-3776 05/08/2018 LEVLANE
2018-3777 05/08/2018 ZYMERGI INC

2018-3778 05/08/2018 COZEN O'CONNOR

2018-378 01/12/2018 Relypsa, Inc.
2018-3781 05/08/2018 WASHINGTON EXAMINER

2018-3782 05/08/2018 FOI Services, Inc.
2018-3783 05/08/2018 NBC NEWS


2018-3789 05/08/2018 Biotex Medical, Inc
2018-379 01/12/2018 Dr Ajay Phadke
2018-3791 05/08/2018 MAYO CLINIC
2018-3792 05/08/2018 Wilsons
2018-3793 05/08/2018 Willingham & Cote

2018-3794 05/08/2018 QUALITY MEDICAL SOLUTIONS LLC
2018-3795 05/08/2018 Kotnik, Donald

2018-3798 05/08/2018 UNIVERSITY OF OKLAHOMA HEALTH SCIENCES CENTER

2018-3799 05/08/2018 Cannon Asset Management
2018-38 01/02/2018 Secure Lead Solutions LLC
2018-380 01/12/2018 paul wiener
2018-3800 05/08/2018 POINTSTATE CAPITAL LP
2018-3801 05/08/2018 Morgan Stanley
2018-3804 05/08/2018 Reuters News

2018-3805 05/08/2018 Easy Dx, Inc. dba LifeHealth
2018-3806 05/08/2018 FOI Services, Inc.

2018-3808 05/08/2018 Doe J
2018-3809 05/08/2018 PEPSICO, INC.
2018-381 01/12/2018 U.S. Right to Know

2018-3812 05/08/2018 FOI Services, Inc.
2018-3816 05/08/2018 FOI Services, Inc.
2018-382 01/12/2018 Saint Gobain Performance Plastics
2018-3820 05/08/2018 FDA NEWS
2018-3821 05/08/2018 FOI Services, Inc.
2018-3826 05/08/2018 FDA NEWS
2018-3827 05/08/2018 FOI Services, Inc.
2018-383 01/12/2018 BLOOMBERG NEWS
2018-3832 05/08/2018 FDA NEWS
2018-3833 05/08/2018 FOI Services, Inc.
2018-3837 05/09/2018 Sean Yu McLoughlin
2018-384 01/12/2018 Cook MyoSite, Inc.

2018-3844 05/09/2018 BEVERIDGE & DIAMOND PC




2018-3861 05/09/2018 Brodsky, Ellen
2018-3862 05/09/2018 Registrar Corp
2018-3863 05/09/2018 Galt Group Inc
2018-3864 05/09/2018 Wine Forest
2018-3865 05/09/2018 Ovid Therapeutics
2018-3866 05/09/2018 FDA NEWS
2018-3867 05/09/2018 HOLTZMAN VOGELJJOSEFIAK ET AL
2018-3868 05/09/2018 Doe J
2018-3869 05/09/2018 ROMAN, GRACE
2018-387 01/12/2018 Jared Valle

2018-3871 05/09/2018 PRITZKER HAGERMAN PA
2018-3872 05/10/2018 BLOOMBERG NEWS

2018-3874 05/10/2018 John Doherty
2018-3876 05/10/2018 Pennock Law Firm

2018-3878 05/10/2018 Steve Millison
2018-3879 05/10/2018 CTFN

2018-388 01/12/2018 LIFE EXTENSION
2018-3880 05/10/2018 FOI Services, Inc.
2018-3881 05/10/2018 SHERMAN, CRAIG

2018-3882 05/10/2018 FDAAWARE
2018-3883 05/10/2018 FOOD SAFETY NEWS

2018-3884 05/10/2018 FOI Services, Inc.
2018-3885 05/10/2018 Scott Street Tomato House

2018-3886 05/10/2018 King & Spalding LLP
2018-3889 05/10/2018 Fzata Inc
2018-3891 05/10/2018 RAY THOMPSON
2018-3892 05/10/2018 Emily Hussey

2018-3893 05/10/2018 Jonathan Sessler
2018-3894 05/10/2018 FOI Services, Inc.
2018-3895 05/10/2018 Jonathan Sessler
2018-3896 05/10/2018 Medical Products Laboratories, Inc.
2018-3897 05/10/2018 Deallus Consulting

2018-39 01/02/2018 LiteCure LLC

2018-3900 05/10/2018 PFIZER INC
2018-3904 05/11/2018 Solvay Chemicals, Inc.
2018-3906 05/11/2018 Raymond James
2018-3908 05/11/2018 SCILUCENT LLC
2018-3909 05/11/2018 BD
2018-391 01/16/2018 FOI Services, Inc.
2018-3910 05/11/2018 Conner, Tiffany
Division of Pharmacoepidemiology and

2018-3912 05/11/2018 Pharmacoeconomics at Brigham and Women's Hospital
2018-3913 05/11/2018 Lee, Jinyoung
2018-3918 05/11/2018 Amin Talati and Upadhye, LLP
2018-3919 05/11/2018 Amin Talati Upadhye, LLO
2018-392 01/16/2018 FOI Services, Inc.
2018-3921 05/11/2018 Ori Maller
2018-3922 05/11/2018 Gerald A. Bagazinski
2018-3923 05/11/2018 Gerald A. Bagazinski

2018-3924 05/14/2018 Suzanne Gorenfeld
2018-3925 05/14/2018 FDAZILLA
2018-3926 05/14/2018 FOOD SAFETY NEWS

2018-3927 05/14/2018 Ori Maller
2018-3928 05/14/2018 The Tampa Bay Times
2018-393 01/16/2018 FOI Services, Inc.
2018-3930 05/14/2018 FDAZILLA

2018-3932 05/14/2018 FDAZILLA

2018-3933 05/14/2018 FDAZILLA
2018-3934 05/14/2018 FDAZILLA
2018-3935 05/14/2018 FDAZILLA

2018-3939 05/14/2018 Orchid Orthopedics
2018-394 01/16/2018 Charity Aitken
2018-3941 05/14/2018 THE UNIVERSITY OF CHICAGO
2018-3942 05/14/2018 FDAZILLA

2018-3943 05/14/2018 Pinnacle Medtech
2018-3945 05/14/2018 epic international thailand co., ltd
2018-3946 05/14/2018 Link Bio Corp.
2018-3947 05/14/2018 PETERSON & ASSOCIATES PC

2018-3949 05/14/2018 NOVAK, MATT
2018-3951 05/14/2018 FDAZILLA
2018-3953 05/14/2018 LANGDON & EMISON

2018-3954 05/14/2018 ARENT FOX LLP
2018-3956 05/14/2018 ATU
2018-3957 05/14/2018 UCLA School of Law Library
2018-3958 05/14/2018 Epstein Becker & Green, P.C.
2018-396 01/16/2018 KHULLAR P.A.

2018-3962 05/14/2018 NBC NEWS
2018-3963 05/14/2018 Noah Wood / Wood Law Firm, LLC
2018-3965 05/14/2018 Roswell Park Comprehensive Cancer Center

2018-3967 05/14/2018 Childers, Schlueter & Smith, LLC
2018-3968 05/14/2018 NBC NEWS

2018-3969 05/14/2018 WILEY REIN LLP
2018-397 01/16/2018 Meitheal Pharmaceuticals Inc
2018-3970 05/14/2018 Cipla USA Inc.

2018-3971 05/14/2018 Visual Solutions
2018-3972 05/14/2018 FOI Services, Inc.
2018-3974 05/14/2018 Kerr, Russell and Weber, PLC
2018-3975 05/14/2018 Lisa contawe

2018-3978 05/14/2018 FOIA GROUP INC
2018-3979 05/14/2018 Pacific Justice Center

2018-3980 05/14/2018 Raymond James
2018-3981 05/14/2018 Allergan attn: Ellen Kawata
2018-3982 05/14/2018 INGENES LLC

2018-3983 05/14/2018 ABC NEWS
2018-3984 05/14/2018 INGENES LLC

2018-3985 05/14/2018 INGENES LLC

2018-3987 05/14/2018 INGENES LLC

2018-399 01/16/2018 Sam Edland
2018-3991 05/14/2018 Conventus Biomedical Solutions, Inc.

2018-3995 05/14/2018 BOYLE SHAUGHNESSY LAW PC
2018-3996 05/14/2018 MCKEEN & ASSOCIATES PC
2018-3998 05/14/2018 Tennessee
2018-4 01/02/2018 Chris Klein
2018-40 01/02/2018 Arteriocyte, Inc d/b/a Compass Biomedical
2018-400 01/16/2018 Aavis Pharmaceuticals

2018-4004 05/15/2018 EPSTEIN, ELLYN
2018-4005 05/15/2018 POTTS LAW FIRM LLC
2018-4006 05/15/2018 FOIA GROUP INC
2018-4007 05/15/2018 FOIA GROUP INC
2018-4008 05/15/2018 MIKART INC
2018-4009 05/15/2018 PORZIO LIFE SCIENCES

2018-4014 05/15/2018 Perkins Coie LLP

2018-4015 05/15/2018 FOI Services, Inc.
2018-4016 05/15/2018 Kowa Company, Ltd.
2018-4017 05/15/2018 FOOD SAFETY NEWS

2018-4018 05/15/2018 MCKINSEY & CO.
2018-4020 05/15/2018 Hopkins Bruce Publishers Corp.

2018-4021 05/15/2018 Doe J
2018-4022 05/15/2018 Toronto Star

2018-4023 05/15/2018 Dylan Bourdeau
2018-4024 05/15/2018 Rafael Escandon
2018-4025 05/15/2018 Toronto Star
2018-4026 05/15/2018 Toronto Star
2018-4027 05/15/2018 Toronto Star
2018-4028 05/15/2018 FDAZILLA

2018-403 01/16/2018 PQ CORPORATION R&D CENTER
2018-4030 05/15/2018 Huesh, Inc.

2018-4031 05/15/2018 FOI Services, Inc.
2018-4032 05/15/2018 Raymond James
2018-4033 05/15/2018 VLP Law Group LLP

2018-4034 05/15/2018 FOIA GROUP INC
2018-4035 05/15/2018 Legacy Pharmaceutical Packaging, LLC
2018-4036 05/15/2018 FDA NEWS
2018-4037 05/15/2018 FOI Services, Inc.

2018-4042 05/15/2018 FDA NEWS
2018-4043 05/15/2018 FOI Services, Inc.
2018-4048 05/15/2018 FOI Services, Inc.
2018-4052 05/15/2018 FOI Services, Inc.
2018-4055 05/15/2018 NIDEK CO LTD

2018-4057 05/16/2018 Raymond James

2018-4059 05/16/2018 FOI Services, Inc.
2018-4060 05/16/2018 Ligand Pharmaceuticals Incorporated
2018-4062 05/16/2018 ADB Interests, LLC
2018-4064 05/16/2018 THE OHIO STATE UNIVERSITY
2018-4065 05/16/2018 FOI Services, Inc.
2018-4066 05/16/2018 Healthcare Value Capital
2018-4067 05/16/2018 FEDERAL DEFENDER SERVICES OF IDAHO

2018-4069 05/16/2018 Deborah Carter
2018-407 01/16/2018 BLOOMBERG NEWS
2018-4071 05/16/2018 Deborah Fellhauer

2018-4075 05/16/2018 Medtronic Xomed

2018-4076 05/16/2018 Doe J
2018-4077 05/16/2018 EASTERN MICHIGAN UNIVERSITY
2018-4078 05/16/2018 Quinlan Partners
2018-4079 05/16/2018 Mike Koehler

2018-408 01/16/2018 CHOC Children's Hospital of Orange County
2018-4080 05/16/2018 Mike Koehler

2018-4083 05/16/2018 Goya Foods, Inc.

2018-4084 05/16/2018 Paul Nork
2018-4086 05/16/2018 ZYMERGI INC
2018-4087 05/16/2018 ZYMERGI INC

2018-4088 05/16/2018 KEYS 22458-017, CLAY
2018-4089 05/16/2018 KEYS 22458-017, CLAY
2018-409 01/16/2018 FOI Services, Inc.

2018-4090 05/16/2018 BRUCE, BRANDON
2018-4091 05/16/2018 CIVCO Medical Solutions

2018-4092 05/16/2018 BOMBARDINI, MORELLA
2018-4094 05/16/2018 Zymergi, Inc.
2018-4095 05/16/2018 CORRESPONDENCE RESEARCH PROJECT
2018-4096 05/16/2018 GORDON & REES LLP

2018-4097 05/17/2018 Raymond James
2018-4098 05/17/2018 Raymond James
2018-41 01/02/2018 BakerHostetler, LLP
2018-410 01/16/2018 TEVA
2018-4100 05/17/2018 john Higson
2018-4101 05/17/2018 BioFilm Inc.
2018-4102 05/17/2018 FOI Services, Inc.
2018-4103 05/17/2018 Gambosi, Gina

2018-4104 05/17/2018 PFIZER INC
2018-4105 05/17/2018 Sidley Austin Brown & Wood LLP

2018-4106 05/17/2018 FOIA GROUP INC
2018-4107 05/17/2018 FOI Services, Inc.

2018-4108 05/17/2018 Bernstein Litowitz Berger & Grossmann LLP
2018-4109 05/17/2018 Darsh Capital
2018-411 01/16/2018 Lawson & Associates
2018-4110 05/17/2018 Weill Cornell Medicine
2018-4111 05/17/2018 PREMIER RESEARCH

2018-4112 05/17/2018 FOI Services, Inc.
2018-4114 05/17/2018 UNC Medical Center
2018-4115 05/17/2018 Takeda Pharmaceuticals C/o Robert P. Bonin Jr
2018-4116 05/17/2018 INDIANA UNIVERSITY SCHOOL OF MEDICINE
2018-4117 05/17/2018 FDAZILLA

2018-4118 05/17/2018 DrugPatentWatch
2018-4119 05/17/2018 Mari Yonomoto

2018-412 01/16/2018 HMI
2018-4120 05/17/2018 AbbVie, Inc.

2018-4122 05/17/2018 Alameda County District Attorney's Office

2018-4124 05/17/2018 Alere ,inc. (Biosite, Inc.)
2018-4127 05/17/2018 Zoetis Inc.

2018-4128 05/17/2018 WuXi AppTec Inc.
2018-4129 05/17/2018 Triple Gate Capital

2018-4131 05/17/2018 sfm Medical Devices USA, Inc.
2018-4132 05/17/2018 Synovis Micro Companies Alliance, Inc.
2018-4134 05/17/2018 ZYMERGI INC
2018-4136 05/18/2018 HAGERMAN INFORMATION SERVICES
2018-4137 05/18/2018 GOODWIN PROCTER LLP
2018-4138 05/18/2018 Mari Yonomoto
2018-4139 05/18/2018 Mari Yonomoto

2018-414 01/16/2018 Halyard Health, Inc.
FEDERAL DEFENDER SERVICES OF EASTERN TENNESSEE
2018-4140 05/18/2018 INC
2018-4141 05/18/2018 AMGEN

2018-4145 05/18/2018 HSBC Securities & Capital Markets (India) Pvt Ltd
2018-4147 05/18/2018 Smart Human Dynamics
2018-4148 05/18/2018 FDAAWARE

2018-4149 05/18/2018 DSanon
2018-415 01/16/2018 Doe J
2018-4151 05/18/2018 Registrar Corp
2018-4152 05/18/2018 SIGN Fracture Care International
2018-4153 05/18/2018 ARTHREX, INC.
2018-4154 05/18/2018 FDAZILLA

2018-4156 05/21/2018 FDAAWARE
2018-4158 05/21/2018 Govzilla, Inc.
2018-4159 05/21/2018 United Safety Agents LLC
2018-4160 05/21/2018 Govzilla, Inc.
2018-4161 05/21/2018 TerraFree LLC
2018-4162 05/21/2018 Govzilla, Inc.
2018-4163 05/21/2018 FDAAWARE
2018-4165 05/21/2018 Topco Associates, LLC

2018-4168 05/21/2018 Hisun Pharmaceuticals USA, Inc.
2018-4169 05/21/2018 Key Surgical, Inc.
2018-4171 05/21/2018 Formycon AG

2018-4174 05/21/2018 FDAZILLA
2018-4175 05/21/2018 DCM
2018-4176 05/21/2018 FOI Services, Inc.
California Institute of Advanced Management
2018-4178 05/21/2018 (CIAM)
2018-4179 05/21/2018 Susanne Gardner

2018-4180 05/21/2018 Carla D AIkens PC
2018-4182 05/21/2018 RyMed Technologies, LLC
2018-4185 05/21/2018 Chison USA Inc.

2018-4188 05/21/2018 NeuroRx, Inc.


MINTZ, LEVIN, COHN, FERRIS, GLOVSKY AND POPEO,
2018-4191 05/21/2018 P.C.
2018-4192 05/21/2018 TODD & WELD LLP
2018-4193 05/21/2018 Raycom Media
2018-4195 05/21/2018 Raycom Media

2018-4196 05/21/2018 Doe J

2018-42 01/02/2018 Catachem, Inc.

2018-4205 05/21/2018 MATRIX MEDICAL DEVICES LLC
2018-4206 05/21/2018 FDA NEWS
2018-4207 05/21/2018 FDA NEWS



2018-4215 05/21/2018 PFIZER INC
2018-4217 05/21/2018 Reuters News

2018-4218 05/21/2018 Reuters News
2018-4219 05/21/2018 NBC NEWS
2018-422 01/16/2018 Personalized Stem Cells, Inc.

2018-4220 05/21/2018 OXFORD UNIVERSITY PRESS
2018-4221 05/21/2018 QUARLES & BRADY LLP
2018-4222 05/21/2018 HEALTH LAW PARTNERS
2018-4223 05/21/2018 GURVEY & BERRY
2018-4224 05/21/2018 Oxygen Development LLC

2018-4225 05/21/2018 WARD #1026408, ADAM
2018-4226 05/21/2018 Bioclinica Research
2018-4227 05/21/2018 FDA NEWS
2018-4228 05/21/2018 FDA NEWS
2018-4229 05/21/2018 FDA NEWS
2018-423 01/16/2018 FOI Services, Inc.
2018-4230 05/21/2018 FDA NEWS
2018-4231 05/21/2018 FDA NEWS
2018-4232 05/21/2018 FDA NEWS
2018-4233 05/21/2018 FDA NEWS
2018-4234 05/21/2018 Emmanuele Angione
2018-4235 05/21/2018 FDA NEWS
2018-4236 05/21/2018 FDA NEWS
2018-4237 05/21/2018 FDA NEWS
2018-4238 05/21/2018 FDA NEWS
2018-4239 05/21/2018 FDA NEWS
2018-424 01/16/2018 BAUSCH + LOMB

2018-4240 05/21/2018 FDA NEWS
2018-4241 05/21/2018 FDA NEWS
2018-4242 05/21/2018 FDA NEWS
2018-4243 05/21/2018 FDA NEWS
2018-4251 05/21/2018 Emilia Javorsky
2018-4254 05/21/2018 Doe J
2018-4255 05/21/2018 Emily Leongini
2018-4256 05/22/2018 FDA NEWS

2018-4259 05/22/2018 FDA NEWS

2018-426 01/16/2018 FOI Services, Inc.
2018-4260 05/22/2018 Ternion Pharmaceuticals
2018-4261 05/22/2018 James Marcy
2018-4262 05/22/2018 Nalini Rajamannan

2018-4263 05/22/2018 Carolina Cabezon
2018-4264 05/22/2018 Craig Nandoo

2018-4265 05/22/2018 Zoetis Inc.
The University of Texas at Tyler Ben and Maytee
2018-4266 05/22/2018 Fisch College of Pharmacy
2018-4267 05/22/2018 Doe J
2018-427 01/16/2018 Mentis Law Group


2018-4274 05/22/2018 Kyle Covill
2018-4275 05/22/2018 Enable Injections, Inc.
2018-4276 05/22/2018 Lori Couture

2018-4279 05/22/2018 McClain, Daniel R
2018-428 01/16/2018 FOI Services, Inc.

2018-4281 05/22/2018 Lori Couture
2018-4285 05/22/2018 Signature Orthopaedics
2018-4286 05/22/2018 RAY THOMPSON
2018-4287 05/22/2018 MORGAN LEWIS & BOCKIUS LLP
2018-4288 05/23/2018 Elos Medtech Pinol A/S
2018-4289 05/23/2018 Odom & Des Roches, LLC

2018-429 01/16/2018 Sam Edland
2018-4290 05/23/2018 Raymond James
2018-4292 05/23/2018 Lori Couture
Royal Customs Brokers Inc DBA Speed Global
2018-4293 05/23/2018 Services
2018-4294 05/23/2018 EverPoint Asset Management, LLC
2018-4295 05/23/2018 MAGNETAR CAPITAL

2018-4297 05/23/2018 Kessler Topaz Meltzer & Check LLP
2018-43 01/02/2018 Pure North S'Energy Foundation

2018-430 01/16/2018 Doe J
2018-4300 05/23/2018 Andrea Woodruff

2018-4305 05/23/2018 TheraBionic Inc
2018-4306 05/23/2018 Xenetic Biosciences

2018-4307 05/23/2018 UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
2018-431 01/16/2018 Registrar Corp
2018-4311 05/23/2018 THE ASSOCIATED PRESS
2018-4312 05/23/2018 Birger Wilov

2018-4313 05/23/2018 EnBiotix, Inc.
2018-4315 05/23/2018 FDAZILLA

2018-4316 05/23/2018 CENTURA HEALTH
2018-4317 05/23/2018 FDAZILLA

2018-4318 05/23/2018 Cherita James/M SquaredAssociates Inc
2018-4319 05/23/2018 FDAZILLA

2018-432 01/16/2018 Jennifer Kempker


2018-4325 05/23/2018 Amazing Productions

2018-4326 05/23/2018 Third North Capital LP
2018-4327 05/23/2018 UC DAVIS

2018-433 01/16/2018 Registrar Corp
2018-4336 05/23/2018 GOJO INDUSTRIES INC

2018-4338 05/23/2018 Tulane University School of Medicine
2018-434 01/16/2018 FDAZILLA
2018-4341 05/23/2018 METALTRONICA
2018-4343 05/23/2018 3M ESPE Dental Products
2018-4344 05/23/2018 MARLER CLARK ATTYS
2018-4345 05/23/2018 MARLER CLARK ATTYS
2018-4346 05/23/2018 Hyman Phelps and McNamara PC
2018-4347 05/24/2018 FOI Services, Inc.

2018-435 01/16/2018 FDAAWARE

2018-4353 05/24/2018 Morrow & White
2018-4358 05/24/2018 OncoNano Medicine Inc
2018-436 01/16/2018 FDAAWARE
2018-4360 05/24/2018 MEDTRONIC
2018-4361 05/24/2018 Alcon Laboratories, Inc.

2018-4362 05/24/2018 Guy Lechien
2018-4364 05/24/2018 FOI Services, Inc.

2018-4368 05/24/2018 Govzilla, Inc.
2018-4369 05/24/2018 Govzilla, Inc.

2018-4370 05/24/2018 NEOGENIX LLC
2018-4371 05/24/2018 OncoMed Pharmaceuticals, Inc.
2018-4372 05/24/2018 Govzilla, Inc.
2018-4373 05/24/2018 FOI Services, Inc.
2018-4374 05/24/2018 KNOWLES, JONATHAN
2018-4375 05/24/2018 STAT, Boston Globe Media

2018-4376 05/24/2018 Beloteca, Inc.
2018-4377 05/24/2018 LIFE EXTENSION
2018-4379 05/24/2018 LIFE EXTENSION

2018-438 01/17/2018 Radagast Pet Food, Inc.
2018-4380 05/24/2018 FOI Services, Inc.
2018-4381 05/24/2018 RA CAPITAL MANAGEMENT
2018-4382 05/24/2018 FOI Services, Inc.
2018-4383 05/24/2018 OncoMed Pharmaceuticals, Inc.

2018-4385 05/24/2018 FOI Services, Inc.
2018-4386 05/24/2018 Doe J

2018-4388 05/25/2018 FOI Services, Inc.
2018-4389 05/25/2018 FOI Services, Inc.
2018-439 01/17/2018 Eywa Pharma Inc.
2018-4391 05/25/2018 Sarah Kalil
2018-4392 05/25/2018 Alcon Laboratories, Inc.

2018-4393 05/25/2018 StimLabs
2018-4394 05/25/2018 Ethicon, Inc.
2018-4395 05/25/2018 Joseph McGinnis
2018-4396 05/25/2018 Eagle Pharmaceuticals, Inc.
2018-4398 05/25/2018 Trinitas Consulting Group
2018-4399 05/25/2018 MEDTRONIC

2018-44 01/02/2018 Laser Pharmaceuticals, LLC
2018-440 01/17/2018 FDAZILLA
2018-4400 05/25/2018 DEMOCRATIC CONGRESSIONAL CAMPAIGN COMMITTEE

2018-4401 05/25/2018 CBS NEWS
2018-4403 05/25/2018 Raymond James

2018-4404 05/25/2018 CNN
2018-4406 05/25/2018 Eisai Inc.

2018-4407 05/25/2018 Lupin Pharmaceutical
2018-4408 05/25/2018 Genentech
2018-4409 05/25/2018 Genentech
2018-441 01/17/2018 FDAZILLA

2018-4411 05/25/2018 BLOOMBERG NEWS

2018-4412 05/25/2018 VistaPharm
2018-4414 05/25/2018 Forouzan Law APC
2018-4415 05/25/2018 FROST VAN DEN BOOM
2018-4418 05/25/2018 CNN
2018-4419 05/25/2018 WEEKLEY SCHULTE ET AL

2018-442 01/17/2018 FOI Services, Inc.
2018-4420 05/25/2018 DEPACE, NICHOLAS L
2018-4421 05/25/2018 Genentech
2018-4422 05/25/2018 Genentech
2018-4423 05/25/2018 Yang, Lawrence

2018-4424 05/29/2018 Carl Zeiss Meditec AG
2018-4425 05/29/2018 MYLAN INC

2018-4426 05/29/2018 FOI Services, Inc.
2018-4427 05/29/2018 FOI Services, Inc.
2018-4429 05/29/2018 FOI Services, Inc.

2018-4430 05/29/2018 Annifer Hung
2018-4431 05/29/2018 PFIZER
2018-4432 05/29/2018 Radiological Service Training Institute

2018-4433 05/29/2018 BARD PERIPHERAL VASCULAR INC
2018-4434 05/29/2018 Oleh Denysyk
2018-4436 05/29/2018 Innovere Medical Inc.
2018-4437 05/29/2018 UC DAVIS

2018-4438 05/29/2018 Martin Army Community Hospital
2018-4439 05/30/2018 Foley and Mansfield

2018-444 01/17/2018 Stifel Nicolaus & Co
2018-4440 05/30/2018 FOI Services, Inc.

2018-4443 05/30/2018 Merge Healthcare Inc.

2018-4444 05/30/2018 igambit inc.
2018-4447 05/30/2018 David Vu
2018-4448 05/30/2018 David Vu

2018-4449 05/30/2018 Stryker AG
2018-445 01/17/2018 FDAZILLA
2018-4450 05/30/2018 AkzoNobel Specialty Chemicals
2018-4451 05/31/2018 FOI Services, Inc.
2018-4452 05/31/2018 AMICUS THERAPEUTICS

2018-4453 05/31/2018 Rebound Therapeutics Corporation
2018-4454 05/31/2018 Medtronic
2018-4457 05/31/2018 PROPUBLICA

2018-4458 05/31/2018 FOI Services, Inc.
2018-4459 05/31/2018 FOI Services, Inc.
2018-446 01/17/2018 FDAZILLA

2018-4460 05/31/2018 Ashland, Inc.
2018-4461 05/31/2018 ZOLL MEDICAL CORPORATION
2018-4462 05/31/2018 THOMSON REUTERS
2018-4463 05/31/2018 Petrova, Rossitza
2018-4464 05/31/2018 BOCOM pharmaceuticals (USA) Corp.
2018-4465 05/31/2018 Registrar Corp
2018-4466 06/01/2018 Hisun Pharmaceuticals USA. Inc.

2018-4467 06/01/2018 UNITED FIRST PARTNERS LLC
2018-4468 06/01/2018 MICHIGAN STATE UNIVERSITY
2018-4469 06/01/2018 Scopia Capital

2018-447 01/17/2018 Crownlux Company Limited
2018-4470 06/01/2018 Raycom Media

2018-4472 06/01/2018 RHODES PHARMACEUTICALS
2018-4473 06/01/2018 Newtyn Management
2018-4474 06/01/2018 Dr. Reddy's Laboratories Ltd.

Dusseldorf Institute for Competition Economics
2018-4476 06/01/2018 (DICE)
2018-4477 06/01/2018 Kevin Corrigan Consulting
2018-4478 06/01/2018 Dead Sea Works Ltd
2018-4479 06/01/2018 ACLEAST LLC
2018-448 01/17/2018 DR. Regenold GmbH
2018-4481 06/01/2018 FOI Services, Inc.
2018-4482 06/01/2018 pro-dex
2018-4483 06/01/2018 Genadyne Biotechnologies, Inc.
2018-4485 06/04/2018 WFBM LLP
2018-4486 06/04/2018 Govzilla, Inc.

2018-4487 06/04/2018 MUCKROCK NEWS
2018-4488 06/04/2018 FOIA GROUP INC
2018-4489 06/04/2018 S ALBERT EDWARDS PHARM D

2018-449 01/17/2018 FOI Services, Inc.
2018-4490 06/04/2018 RIDINGS, BRENDAN

2018-4491 06/04/2018 FOIA GROUP INC
2018-4492 06/04/2018 FOIA GROUP INC

2018-4496 06/04/2018 CLIFFORD CHANCE

2018-4498 06/04/2018 Dr Ajay Phadke
2018-4499 06/04/2018 Pacific Link Consulting
2018-45 01/02/2018 Aesculap, Inc.
2018-450 01/17/2018 FDAZILLA
2018-4500 06/04/2018 SHRADER 7 ASSOCIATES LLP

2018-4502 06/04/2018 Cosmopolitan Legal, PLLC

2018-4507 06/04/2018 Songwon Industrial Americas

2018-4509 06/04/2018 Songwon Industrial Americas
2018-4510 06/04/2018 FOI Services, Inc.
2018-4512 06/04/2018 Dr Ajay Phadke
2018-4513 06/04/2018 Buzzfeed News

2018-4517 06/04/2018 RDD PHarma Inc
2018-4518 06/04/2018 Connexicon Medical
2018-4520 06/04/2018 Eurofins

2018-4522 06/04/2018 SURE-TECH DIAGNOSTIC ASSOCIATES INC

2018-4524 06/04/2018 VistaPharm

2018-4526 06/04/2018 DuVal & Associates, P.A.
2018-4527 06/04/2018 NSF International

2018-4529 06/04/2018 FDAZILLA
2018-4530 06/04/2018 Cipla Limited
2018-4532 06/04/2018 FOI Services, Inc.
2018-4533 06/04/2018 Sean J. Powell

2018-4534 06/04/2018 Dr Ajay Phadke
University of California Los Angeles School of

2018-4535 06/04/2018 Dentistry- Student Youngshin Lee
2018-454 01/17/2018 Debra Bennett

2018-4546 06/04/2018 NBC UNIVERSAL
2018-4547 06/04/2018 Skadden, Arps, Slate, Meagher & Flom LLP
2018-4549 06/04/2018 HEAVEN, SUI L
2018-455 01/17/2018 FOI Services, Inc.
2018-4550 06/04/2018 WPTV-TV
2018-4551 06/04/2018 THOMSON REUTERS

2018-4552 06/05/2018 TERRY GARMEY & ASSOCIATES
2018-4553 06/05/2018 Agrivida, Inc.
2018-4554 06/05/2018 Bruce McIntosh
2018-4555 06/05/2018 Yang, Lawrence

2018-4556 06/05/2018 FDAZILLA
2018-4557 06/05/2018 Registrar Corp
2018-4558 06/05/2018 Shanna Ryan
2018-4559 06/05/2018 RAY THOMPSON
2018-4560 06/05/2018 Joseph C. Murray & Co
2018-4561 06/05/2018 RAY THOMPSON

2018-4562 06/05/2018 Hearst Connecticut Media
2018-4563 06/05/2018 Registrar Corp
2018-4564 06/05/2018 RAY THOMPSON

2018-4565 06/05/2018 RAY THOMPSON
2018-4566 06/05/2018 RAY THOMPSON
2018-4567 06/05/2018 RAY THOMPSON
2018-4568 06/05/2018 RAY THOMPSON
2018-4569 06/05/2018 RAY THOMPSON

2018-457 01/17/2018 Needle and Ellenberg, PA
2018-4570 06/05/2018 Otto Bock HealthCare Products GmbH
2018-4571 06/05/2018 RAY THOMPSON
2018-4572 06/05/2018 Intervet Inc. (d/b/a Merck Animal Health)
2018-4573 06/05/2018 RAY THOMPSON

2018-4574 06/05/2018 RAY THOMPSON
2018-4575 06/05/2018 JOHN PRICE LAW FIRM LLC
2018-4576 06/05/2018 Dolat Capital Market Private Limited
2018-4577 06/05/2018 RAY THOMPSON

2018-4578 06/05/2018 Gedeon Richter Plc.
2018-4579 06/05/2018 BLOOMBERG NEWS
2018-458 01/17/2018 WuXi AppTec Inc.
2018-4580 06/05/2018 PFIZER ESSENTIAL HEALTH

2018-4581 06/05/2018 BURDOCK GROUP
2018-4583 06/05/2018 Shilpa Medicare Limited

2018-4584 06/05/2018 B&H Consulting Services - Sean Decker
2018-4586 06/05/2018 The Ohio State University College of Medicine

2018-4587 06/05/2018 Intarcia Therapeutics, Inc
2018-4588 06/05/2018 FOI Services, Inc.
2018-4589 06/05/2018 BF Innovation Inc.
2018-459 01/17/2018 Masimo Corporation
2018-4590 06/05/2018 Ascensia Diabetes Care

2018-4592 06/05/2018 Gina To
2018-4593 06/05/2018 Alpha Broker Corp.

2018-4595 06/05/2018 KAPLAN RICE LLP

2018-46 01/02/2018 Brown Moskowitz & Kallen, P.C.

2018-4603 06/05/2018 GRAS ASSOCIATES LLC
2018-4605 06/05/2018 CAULFIELD, HARRY
2018-4607 06/05/2018 FOLEY HOAG LLP
2018-4608 06/05/2018 EPSTEIN BECKER & GREEN PC
2018-4609 06/06/2018 Hyman, Phelps & McNamara P.C.
2018-4610 06/06/2018 Salli USA
2018-4613 06/06/2018 DEPARTMENT OF THE ARMY
2018-4614 06/06/2018 Proteus Digital Health

2018-4619 06/06/2018 Pro-Dex, Inc.
2018-4620 06/06/2018 Arbit Consulting, LLC
2018-4621 06/06/2018 Holland, Matt

2018-4622 06/06/2018 FOIA GROUP INC
2018-4623 06/06/2018 FOIA GROUP INC
2018-4624 06/06/2018 FOIA GROUP INC
2018-4625 06/06/2018 ABC NEWS

2018-4628 06/06/2018 COREPHARMA LLC
2018-4629 06/06/2018 PL DEVELOPMENTS
2018-4630 06/06/2018 Extera Partners
2018-4631 06/07/2018 Raley's
2018-4633 06/07/2018 HOLLAND, A
2018-4634 06/07/2018 FOIA GROUP INC

2018-4635 06/07/2018 FDAZILLA
2018-4636 06/07/2018 SOVEREIGN PHARMACEUTICALS, INC.
2018-4637 06/07/2018 FDAZILLA

2018-4639 06/07/2018 FDAAWARE
2018-464 01/17/2018 FDAZILLA

2018-4643 06/07/2018 Sharon FItzhenry

2018-4644 06/07/2018 Valeant Pharmaceuticals International, Inc.
2018-4647 06/07/2018 FOI Services, Inc.

2018-4649 06/07/2018 FOI Services, Inc.
2018-465 01/17/2018 FDAZILLA

2018-4650 06/07/2018 GCP ID
2018-4652 06/07/2018 FDAZILLA

2018-4653 06/07/2018 FOI Services, Inc.
2018-4654 06/07/2018 FOI Services, Inc.
2018-4655 06/07/2018 Extera Partners

2018-4657 06/07/2018 RAY THOMPSON
2018-4658 06/07/2018 JOHNSON MATTHEY
2018-4659 06/07/2018 LIFE EXTENSION
2018-466 01/17/2018 FDAZILLA
2018-4660 06/07/2018 RAY THOMPSON

2018-4661 06/07/2018 Registrar Corp
2018-4663 06/07/2018 Registrar Corp
2018-4664 06/07/2018 RAY THOMPSON

2018-4665 06/07/2018 Bonilla, Juan L
2018-4666 06/07/2018 FDAZILLA
2018-4667 06/07/2018 FDAZILLA
2018-4668 06/07/2018 BLOOMBERG NEWS

2018-4669 06/08/2018 RAY THOMPSON
2018-467 01/17/2018 FDAZILLA

2018-4670 06/08/2018 White and Steele, P.C.
2018-4671 06/08/2018 RAY THOMPSON
2018-4672 06/08/2018 RAY THOMPSON
2018-4673 06/08/2018 RAY THOMPSON

2018-4674 06/08/2018 FOI Services, Inc.
2018-4675 06/08/2018 Registrar Corp
2018-4676 06/08/2018 Neurocarrus, Inc
2018-4677 06/08/2018 RAY THOMPSON

2018-4678 06/08/2018 RAY THOMPSON
2018-4679 06/08/2018 FOI Services, Inc.
2018-468 01/17/2018 FOI Services, Inc.
2018-4680 06/08/2018 Chantal M Beauregard

2018-4681 06/08/2018 SUPERVALU Inc.
2018-4683 06/08/2018 FDAZILLA
2018-4684 06/08/2018 RIVKIN RADLER & KREMER
2018-4685 06/08/2018 FDAZILLA

2018-4686 06/08/2018 Impax Laboratories LLC
2018-4687 06/08/2018 FOI Services, Inc.

2018-4689 06/08/2018 RAY THOMPSON
2018-469 01/18/2018 The Forty To See, Inc.

2018-4690 06/08/2018 Registrar Corp
2018-4691 06/11/2018 Doe J
2018-4692 06/11/2018 INNOVATIVE STERILIZATION TECHNOLOGIES

2018-4693 06/11/2018 WRIGHT, CURTIS W
2018-4694 06/11/2018 LIEFF, CABRASER, HEIMANN & BERNSTEIN, LLP

2018-4697 06/11/2018 Intervet Inc. (d/b/a Merck Animal Health)

2018-470 01/18/2018 FOI Services, Inc.
2018-4701 06/11/2018 dorsey, james
2018-4702 06/11/2018 Janssen Pharmaceuticals

2018-4704 06/11/2018 DELEON, ERIC
2018-4706 06/11/2018 WFBM LLP

2018-471 01/18/2018 FOI Services, Inc.

2018-4711 06/11/2018 DKL Law PLLC
2018-4712 06/11/2018 FDA NEWS


2018-4717 06/11/2018 MUCKROCK NEWS

2018-4719 06/11/2018 MUCKROCK
2018-472 01/18/2018 Halyard Health
2018-4723 06/11/2018 FDAZILLA

2018-4725 06/11/2018 FDAZILLA

2018-4727 06/11/2018 Emma Censky
2018-4728 06/11/2018 FDAZILLA

2018-4729 06/11/2018 FDAZILLA
2018-473 01/18/2018 FOI Services, Inc.
2018-4730 06/11/2018 FDAZILLA
2018-4731 06/11/2018 FOI Services, Inc.

2018-4732 06/11/2018 GEISINGER MEDICAL CENTER
2018-4733 06/11/2018 FDAZILLA

2018-4734 06/11/2018 UNIVERSITY OF MISSOURI-KANSAS CITY
2018-4735 06/11/2018 GEISINGER MEDICAL CENTER
2018-4736 06/11/2018 FDAZILLA

2018-4739 06/11/2018 Hyman, Phelps & McNamara P.C.

2018-4740 06/11/2018 JM HUBER CORP
2018-4741 06/11/2018 GAMMA SEAFOOD CORP
2018-4745 06/11/2018 ALFA INTERNATIONAL SEAFOOD INC
2018-4749 06/12/2018 OFW LAW

2018-4750 06/12/2018 Stacy Hovatter
2018-4751 06/12/2018 Chapman Law Group

2018-4752 06/12/2018 Oppenheimer & Co.
2018-4753 06/12/2018 DE LA PARTE & GILBERT
2018-4754 06/12/2018 Doe J
2018-4755 06/12/2018 G.C. Hanford Manufacturing Company
2018-4756 06/12/2018 Miles, Sears & Eanni
2018-4758 06/12/2018 Miles, Sears & Eanni
2018-4759 06/12/2018 Kessler Topaz Meltzer & Check LLP

2018-476 01/18/2018 MEDTRONIC NAVIGATION INC
2018-4760 06/12/2018 Conformis, Inc.
2018-4761 06/12/2018 Dead Sea Works Ltd.
2018-4762 06/12/2018 UNIVERSITY COLLEGE LONDON

2018-4764 06/12/2018 RANTEESI F-41729, SIMON
2018-4765 06/12/2018 FDAZILLA

2018-4767 06/12/2018 Doe J
2018-4768 06/12/2018 Shen, Chengyu
2018-4769 06/12/2018 TerraFree LLC
2018-477 01/18/2018 FOI Services, Inc.

2018-4770 06/12/2018 SHIRE

2018-4772 06/12/2018 Landry Law P.C.
2018-4773 06/12/2018 Valerie Tolbert
2018-4774 06/12/2018 GILL & GILL SC
2018-4777 06/12/2018 FOOD SAFETY NEWS

2018-4778 06/12/2018 FOI Services, Inc.
2018-4779 06/12/2018 Politecnico Di Milano
2018-478 01/18/2018 CSL BEHRING
2018-4780 06/12/2018 GREENBERG TRAURIG

2018-4781 06/12/2018 ASTELLAS PHARMA US INC
2018-4782 06/12/2018 Doe J
2018-4783 06/12/2018 CHAMP 168896, JEAN PHILLIP
2018-4784 06/12/2018 MADA MEDICAL PRODUCTS INC
2018-4785 06/12/2018 Thixton, Susan
2018-4786 06/12/2018 Hearst Connecticut Media
2018-4787 06/13/2018 FDAAWARE
2018-4788 06/13/2018 FDAAWARE
2018-4789 06/13/2018 Doe J
2018-479 01/18/2018 Joseph Schrempp
2018-4790 06/13/2018 Iris Hewlett
2018-4791 06/13/2018 Medicine Open Access Initiative
2018-4792 06/13/2018 Baron & Budd, PC

2018-4794 06/13/2018 Induction Therapies, LLC
2018-4795 06/13/2018 WEST PHARMACEUTICAL SERVICES
2018-4796 06/13/2018 FDAZILLA

2018-4798 06/13/2018 Aviv Biomedical, Inc.
2018-4799 06/13/2018 FOIA GROUP INC
2018-48 01/02/2018 COMPASSION OVER KILLING
2018-480 01/18/2018 Joseph McGinnis
2018-4800 06/13/2018 Frank Sparks

2018-4801 06/13/2018 FOI Services, Inc.
2018-4802 06/13/2018 Landry Law P.C.
2018-4803 06/13/2018 FOI Services, Inc.
2018-4804 06/13/2018 FOI Services, Inc.

2018-4805 06/13/2018 FDAZILLA
2018-4806 06/13/2018 FDAZILLA

2018-4807 06/13/2018 Fox Law APC
2018-4808 06/13/2018 Terumo Heart Inc.
2018-4809 06/13/2018 FOI Services, Inc.
2018-481 01/18/2018 STEPTOE & JOHNSON
2018-4810 06/13/2018 HETERO USA INC

2018-4811 06/13/2018 HAGERMAN INFORMATION SERVICES
2018-4813 06/13/2018 FDA NEWS

2018-4814 06/13/2018 The Dow Chemical Company
2018-4815 06/13/2018 GlaxoSmithKline
2018-4818 06/13/2018 Aylstock, Witkin, et al.

2018-4819 06/13/2018 Simpson Thacher & Bartlett
2018-482 01/18/2018 Law Office of Mark Itzkoff

2018-4820 06/13/2018 WASHINGTON POST
2018-4821 06/13/2018 Jonas Gulmez


2018-483 01/18/2018 FDANEWS
2018-4830 06/13/2018 GENENTECH INC
2018-4831 06/13/2018 FOOD SAFETY NEWS


2018-4837 06/14/2018 FOOD SAFETY NEWS
2018-4838 06/14/2018 Pharmagellan LLC

2018-484 01/18/2018 Doe J
2018-4840 06/14/2018 FOI Services, Inc.
2018-4841 06/14/2018 Trace Minerals Research
2018-4842 06/14/2018 FOOD SAFETY NEWS
2018-4843 06/14/2018 FOI Services, Inc.

2018-4844 06/14/2018 FOOD SAFETY NEWS
2018-4845 06/14/2018 FOOD SAFETY NEWS
2018-4846 06/14/2018 GF Consulting LLC
2018-4848 06/14/2018 FOI Services, Inc.

2018-485 01/18/2018 FOI Services, Inc.

2018-4854 06/14/2018 MASSACHUSETTS INSTITUTE OF TECHNOLOGY

2018-4855 06/14/2018 Doe J

2018-4857 06/14/2018 VisionQuest Biomedical
2018-486 01/18/2018 FOI Services, Inc.
2018-4860 06/14/2018 Extera Partners

2018-4863 06/14/2018 FRESCA MEDICAL
2018-4864 06/14/2018 Thixton, Susan
2018-4865 06/14/2018 JOHNATHAN SETH, HARPER BE4117
2018-4867 06/14/2018 HAZLETT, STANLEY
2018-4868 06/14/2018 BAYLOR HEART AND VASCULAR INSTITUTE
2018-4869 06/14/2018 GARDNER 6643244, GORDON
2018-487 01/18/2018 STERIS CORP

2018-4870 06/14/2018 Retrophin, Inc.
2018-4871 06/14/2018 Thermo Fisher Scientific
2018-4872 06/14/2018 DANIEL & ASSOCIATES LLC
2018-4873 06/14/2018 MYVACCINELAWYER
2018-4874 06/14/2018 Buzzfeed News
2018-4875 06/14/2018 LEARNING FOUNDATION
2018-4876 06/14/2018 GLOVER, DAVID
2018-4877 06/15/2018 FDAZILLA

2018-4878 06/15/2018 Grant DuBois
2018-4879 06/15/2018 Kubicki Draper, P.A.

2018-488 01/18/2018 STERIS CORP
2018-4881 06/15/2018 Ingredion Inc.
2018-4882 06/15/2018 thirty-two degrees, LLC
2018-4883 06/15/2018 Shire Oncology

2018-4886 06/15/2018 Oculis ehf

2018-4889 06/15/2018 VLP Law Group LLP
2018-489 01/18/2018 STERIS CORP

2018-4890 06/15/2018 Innovize
2018-4891 06/15/2018 Revance Therapeutics, Inc.

2018-4892 06/15/2018 Sagent Pharmaceuticals, Inc.
2018-4894 06/15/2018 Next Orthosurgical, Inc.
2018-4895 06/15/2018 STEPTOE & JOHNSON
2018-4896 06/15/2018 NORTH CAROLINA STATE UNIVERSITY
2018-49 01/02/2018 University of Oregon School of Law
2018-490 01/18/2018 STERIS CORP
2018-4900 06/15/2018 FOI Services, Inc.
2018-4904 06/15/2018 FOI Services, Inc.
2018-4908 06/15/2018 FOI Services, Inc.
2018-491 01/18/2018 DONAPHIN, CELICA
2018-4912 06/15/2018 FDA NEWS
2018-4913 06/15/2018 FOI Services, Inc.
2018-4918 06/15/2018 FDA NEWS
2018-4919 06/15/2018 FOI Services, Inc.
2018-4924 06/15/2018 FDA NEWS
2018-4925 06/15/2018 FOI Services, Inc.
2018-4929 06/18/2018 FDAZILLA
2018-493 01/18/2018 Mentis Law Group
2018-4931 06/18/2018 Indianapolis Business Journal

2018-4932 06/18/2018 University of ottawa
2018-4934 06/18/2018 lisa douglass
2018-4935 06/18/2018 Wake Forest University
2018-4937 06/18/2018 FOOD SAFETY NEWS
2018-4938 06/18/2018 FOOD SAFETY NEWS
2018-4939 06/18/2018 FOOD SAFETY NEWS

2018-494 01/18/2018 LEESFIELD SCOLARO PA
2018-4940 06/18/2018 FOOD SAFETY NEWS
2018-4941 06/18/2018 Dr Ajay Phadke
2018-4942 06/18/2018 TeraRecon, Inc.
2018-4944 06/18/2018 SpinoS Lifescience and Research Private Limited

2018-4946 06/18/2018 FOIA GROUP INC
2018-4947 06/18/2018 FOIA GROUP INC
2018-4948 06/18/2018 BOVIE MEDICAL CORPORATION

2018-4949 06/18/2018 KNOWLES, JONATHAN
2018-495 01/18/2018 SCHRAM, EVA
2018-4950 06/18/2018 Focus For Health

2018-4951 06/18/2018 FOI Services, Inc.
2018-4952 06/18/2018 Joshua Wu
2018-4954 06/18/2018 Shenzhen Hlongmed Biotech Co.,Ltd
2018-4955 06/18/2018 LAW OFFICES OF STEVEN A. ELIA, APC

2018-4958 06/18/2018 Copyright Clearance Center on behalf of client
2018-4959 06/18/2018 Boston Globe: Stat
2018-496 01/18/2018 STEVEN BRACCI PA

2018-4960 06/18/2018 Victoria Forsmo
2018-4963 06/18/2018 HOSPIRA INC
2018-4964 06/18/2018 INTERTEK
2018-4965 06/18/2018 SoundRocket
2018-4966 06/18/2018 FOI Services, Inc.
2018-4967 06/18/2018 Millstone Medical Outsourcing Inc., LLC
2018-4968 06/18/2018 LINCARE INC

2018-4969 06/18/2018 PHASEBIO PHARMACEUTICALS INC
2018-497 01/18/2018 Commonwealth Brands, Inc.
2018-4971 06/18/2018 Wilson Sonsini Goodrich & Rosati

2018-4972 06/18/2018 Doe J
2018-4973 06/18/2018 COLLEY #45043-019, TERRY J
2018-4974 06/18/2018 NY PUBLIC RADIO
2018-4976 06/18/2018 ROMINGER MEDIZINTECHNIK GMBH
2018-4977 06/18/2018 HORSE AUTHORITY

2018-4979 06/19/2018 CHICAGO TRIBUNE
2018-498 01/18/2018 FONG, CHI
2018-4982 06/19/2018 C. Griffin
2018-4984 06/19/2018 Empire State Consumer Project, Inc

2018-4985 06/19/2018 EyeFree assisting communication ltd
2018-499 01/19/2018 Amy Lynn

2018-4992 06/19/2018 EMD Strategies
2018-4994 06/19/2018 MEDTRONIC
2018-4995 06/19/2018 Allergan,Inc.

2018-4996 06/19/2018 Millipede Inc
2018-4997 06/19/2018 Civil Eats
2018-4998 06/19/2018 ELI LILLY & CO

2018-4999 06/19/2018 SANOFI
2018-5 01/02/2018 Sharron Betts

2018-500 01/19/2018 DCM
2018-5000 06/19/2018 Pfizer Consumer Healthcare

2018-5002 06/19/2018 EMD Strategies
2018-5003 06/19/2018 Emkay Global

2018-5004 06/19/2018 CRBARD
2018-5005 06/19/2018 DCM
2018-5006 06/19/2018 LATHAM & WATKINS
2018-5007 06/19/2018 FOI Services, Inc.


2018-501 01/19/2018 DCM
2018-5010 06/19/2018 LIFE SPINE LLC
2018-5011 06/19/2018 WILLIS LAW GROUP
2018-5013 06/19/2018 SIEGEL BRILL PA

2018-5016 06/19/2018 Doe J
2018-5018 06/20/2018 FOI Services, Inc.
2018-5019 06/20/2018 Casey Shannon
2018-502 01/19/2018 DCM
2018-5020 06/20/2018 Brian Hooker

2018-5021 06/20/2018 Vela Diagnostics USA Inc.
2018-5023 06/20/2018 Scott A. Hodes, Attorney at Law

2018-5024 06/20/2018 DCM
2018-5025 06/20/2018 FDAZILLA
2018-5026 06/20/2018 DCM
2018-5027 06/20/2018 dBMEDx
2018-5028 06/20/2018 FOI Services, Inc.
2018-5029 06/20/2018 FOI Services, Inc.
2018-503 01/19/2018 Law Offices of Irving L. Wiesen P.C.
2018-5030 06/20/2018 UNIVERSITY OF FLORIDA
2018-5031 06/20/2018 FOI Services, Inc.
2018-5032 06/20/2018 FOI Services, Inc.
2018-5033 06/20/2018 MEDTRONIC
2018-5034 06/20/2018 BEDFONT SCIENTIFIC LTD
2018-5035 06/20/2018 Raymon Bazinet
2018-5036 06/20/2018 FOI Services, Inc.

2018-5037 06/20/2018 FOI Services, Inc.
2018-5038 06/20/2018 DCM
2018-5039 06/20/2018 FDAZILLA

2018-504 01/19/2018 OPKO Diagnostics, LLC
2018-5040 06/20/2018 Handley & Anderson PLLC
2018-5041 06/20/2018 WILEY REIN LLP

2018-5042 06/20/2018 Vela Diagnostics USA Inc.
2018-5043 06/20/2018 FDAAWARE

2018-5044 06/20/2018 Fate Therapeutics, Inc.
2018-5045 06/20/2018 WILLIAM BLAIR & CO

2018-5047 06/20/2018 LICONA, JACOBO

2018-5049 06/20/2018 Doe J
2018-505 01/19/2018 California Institute of Advanced Management
2018-5050 06/20/2018 ADAMS B03660, ANTHONY
2018-5051 06/20/2018 KLINE & SPECTER

2018-5053 06/21/2018 Herbally Yours
2018-5054 06/21/2018 T. Rowe Price
2018-5056 06/21/2018 FOI Services, Inc.
2018-5057 06/21/2018 Panthera Dental inc.
2018-5058 06/21/2018 FOI Services, Inc.

2018-506 01/19/2018 Ativa Medical

2018-5061 06/21/2018 Acoustiic Inc.
2018-5062 06/21/2018 Acoustiic Inc.
2018-5063 06/21/2018 FOI Services, Inc.
2018-5064 06/21/2018 FOI Services, Inc.
2018-5065 06/21/2018 U.S. Right to Know

2018-5066 06/21/2018 PCCA
2018-5067 06/21/2018 PCCA
2018-5068 06/21/2018 KELLEY DRYE & WARREN LLP
2018-5069 06/21/2018 FOI Services, Inc.
2018-5070 06/21/2018 Evan Anderson
2018-5071 06/21/2018 PAREXEL INTERNATIONAL CORP

2018-5074 06/21/2018 FOI Services, Inc.
2018-5075 06/21/2018 Ramboll Environ US Corporation
2018-5076 06/21/2018 WABC-TV
2018-5079 06/21/2018 FDA NEWS
2018-508 01/19/2018 Stahlbush Island Farms

2018-5082 06/22/2018 FDAZILLA

2018-5083 06/22/2018 Brenda Bloomfield
2018-5084 06/22/2018 FDAZILLA
2018-5086 06/22/2018 FOI Services, Inc.
2018-5087 06/22/2018 FDA NEWS
2018-5088 06/22/2018 FDA NEWS
2018-5089 06/22/2018 FDA NEWS

2018-5090 06/22/2018 FDA NEWS
2018-5091 06/22/2018 FDA NEWS
2018-5092 06/22/2018 FDA NEWS
2018-5093 06/22/2018 FDA NEWS
2018-5094 06/22/2018 FDA NEWS
2018-5095 06/22/2018 FDA NEWS
2018-5096 06/22/2018 FDA NEWS
2018-5097 06/22/2018 FDA NEWS

2018-5098 06/22/2018 FDA NEWS
2018-5099 06/22/2018 FDA NEWS

2018-510 01/19/2018 Vitality Biopharma, Inc.
2018-5100 06/22/2018 FDA NEWS

2018-5101 06/22/2018 FDA NEWS
2018-5102 06/22/2018 FDA NEWS
2018-5103 06/22/2018 FDA NEWS
2018-5104 06/22/2018 FDA NEWS
2018-5105 06/22/2018 FDA NEWS
2018-5106 06/22/2018 FDA NEWS
2018-5107 06/22/2018 FDA NEWS
2018-5108 06/22/2018 PharmaForce Inc.
2018-5109 06/22/2018 PharmaForce Inc.
2018-5110 06/22/2018 Kahn, Carrie
2018-5111 06/22/2018 GOJO INDUSTRIES INC

2018-5112 06/22/2018 Provepharm Inc
2018-5114 06/22/2018 UPSHER-SMITH LABORATORIES INC
2018-5116 06/25/2018 NEW YORK TIMES

2018-5119 06/25/2018 Kaiser Permanente / Jennifer Day, PharmD

2018-512 01/19/2018 Aspire Bariatrics, Inc
2018-5121 06/25/2018 Ramboll Environ US Corporation
Brigham and Women's Hospital, Harvard Medical

2018-5122 06/25/2018 School
2018-5123 06/25/2018 RetroVascular, Inc.
Wake Forest University, School of Law, Innocence
2018-5124 06/25/2018 & Justice Clinic
2018-5125 06/25/2018 FOI Services, Inc.
2018-5126 06/25/2018 VENABLE LLP
2018-5127 06/25/2018 FOI Services, Inc.
2018-5128 06/25/2018 Xenon Pharmaceuticals USA Inc.
2018-5129 06/25/2018 Cardno ChemRisk

2018-513 01/19/2018 PURDUE UNIVERSITY
2018-5130 06/25/2018 FOI Services, Inc.
2018-5131 06/25/2018 Jaakko Lappalainen
2018-5132 06/25/2018 JOURNALISTS
2018-5133 06/25/2018 FOI Services, Inc.

2018-5134 06/25/2018 FOI Services, Inc.
2018-5135 06/25/2018 DNA Electronics, Inc.
2018-5136 06/25/2018 FOIA GROUP INC
2018-5137 06/25/2018 Prelude Dynamics LLC
2018-5138 06/25/2018 PruGen, Inc
2018-5139 06/25/2018 UPSHER-SMITH LABORATORIES INC
2018-5140 06/25/2018 FOI Services, Inc.
2018-5141 06/25/2018 Elizabeth Carney

2018-5142 06/25/2018 BioPharmX
2018-5143 06/25/2018 Napoli Shkolnik PLLC - Salvatore Badala

2018-5144 06/25/2018 ARTHREX, INC.
2018-5145 06/25/2018 FOI Services, Inc.
2018-5146 06/25/2018 FOI Services, Inc.
2018-5147 06/25/2018 Fox Law APC
2018-5148 06/25/2018 UNIVERSITY OF WISCONSIN-MADISON
2018-5149 06/25/2018 Mari Yonomoto

2018-515 01/19/2018 ABBOTT POINT OF CARE INC
2018-5150 06/25/2018 Generichem Corporation
2018-5151 06/25/2018 kenneth atwood
CITY OF HOPE NATIONAL MEDICAL CENTER DEPARTMENT
2018-5153 06/26/2018 OF NURSING RESEARCH AND EDUCATION

2018-5156 06/26/2018 Aplex Trading SAC
2018-5157 06/26/2018 Mary Christine Hancock
2018-5159 06/26/2018 Kim, Min Jeong

2018-516 01/19/2018 Sivan Luder

2018-5162 06/26/2018 Audrey Yarbrough
2018-5165 06/26/2018 Hyunsung Kim

2018-5167 06/26/2018 FOI Services, Inc.
2018-5168 06/26/2018 DELUCA & WEIZENBAUM LTD
2018-5169 06/26/2018 MEDAGENT. Inc.
2018-5171 06/26/2018 ARTHREX, INC.
2018-5172 06/26/2018 D Sanon
2018-5173 06/26/2018 TODD & WELD LLP
2018-5176 06/26/2018 Arbit Consulting, LLC

2018-5177 06/26/2018 INTERTEK
2018-5178 06/26/2018 BENNETT BIGELOW & LEEDOM PS
2018-5179 06/26/2018 MIAMI HERALD

2018-5180 06/26/2018 Frozen Specialties, Inc.
2018-5181 06/26/2018 DocGraph Journal

2018-5183 06/26/2018 Athenex, Inc.
2018-5184 06/26/2018 Athenex, Inc.
2018-5185 06/26/2018 StimLabs

2018-5189 06/26/2018 OrbiMed Adivsors LLC
2018-5190 06/26/2018 Mike Rashti

2018-5191 06/26/2018 ARCE 92A9982, JULIO
2018-5192 06/26/2018 BLOOMBERG NEWS
2018-5193 06/26/2018 Patheon UK Limited

2018-5194 06/26/2018 FOX ROTHSCHILD LLP
2018-5196 06/26/2018 Vairetta, Patricia
2018-5198 06/26/2018 BUGSHAW #231613, EDWARD
2018-5199 06/26/2018 Napoli Shkolnik PLLC - Salvatore Badala
2018-52 01/03/2018 OFW LAW

2018-520 01/19/2018 Doe J
2018-5200 06/26/2018 Primedica Laboratories, LLC

2018-5201 06/26/2018 Center for the Study of Empathicv Therapy
2018-5202 06/26/2018 Biomed Oy
2018-5203 06/26/2018 Baker Botts L.L.P.
2018-5204 06/26/2018 Primedica Laboratories, LLC

2018-5205 06/26/2018 FOI Services, Inc.
2018-5206 06/26/2018 UNITE HERE LOCAL 23

2018-5207 06/27/2018 CR BARD INC
2018-5208 06/27/2018 Eyenuk, Inc
2018-5209 06/27/2018 KennedysCMK LLP
2018-521 01/19/2018 LIPSMAN, MARK

2018-5211 06/27/2018 BARUCH COLLEGE

2018-5212 06/27/2018 Z-Medica, LLC
2018-5213 06/27/2018 Marianna Beauty
2018-5214 06/27/2018 BeaconLight Capital

2018-5215 06/27/2018 R&D Systems, Inc.
2018-5216 06/27/2018 ARTHREX, INC.
2018-5217 06/27/2018 Bigfoot Biomedical
2018-5219 06/27/2018 Church & Dwight Co., Inc.

2018-522 01/19/2018 O2 CONCEPTS
2018-5220 06/27/2018 Arthrex, Inc.
2018-5222 06/27/2018 ARTHREX, INC.
2018-5223 06/27/2018 TF Health Co.
2018-5224 06/27/2018 KANSAS STATE UNIVERSITY
2018-5225 06/27/2018 MISSION PHARMACAL COMPANY/PRESIDENT



2018-524 01/19/2018 FDA NEWS

2018-5241 06/28/2018 Emma Best
2018-5242 06/28/2018 FOI Services, Inc.

2018-5243 06/28/2018 Chison USA Inc.
2018-5244 06/28/2018 Chison USA Inc.
2018-5245 06/28/2018 PQ CORPORATION R&D CENTER

2018-5247 06/28/2018 JONES DAY
2018-5248 06/28/2018 Oppenheimer & Co.
2018-5249 06/28/2018 Mark Campbell
2018-525 01/19/2018 FOI Services, Inc.
2018-5250 06/28/2018 Pharmgate LLC
2018-5251 06/28/2018 Pharmgate LLC

2018-5253 06/29/2018 Cargill, Incorporated
2018-5254 06/29/2018 Kevin Randall
2018-5255 06/29/2018 Kennedy Hodges
2018-5256 06/29/2018 Crain | Schuette Attorneys

2018-5257 06/29/2018 FOOD SAFETY NEWS
2018-5259 06/29/2018 Pharmgate LLC

2018-5260 07/02/2018 Mintz Levin Cohn Ferris Glovsky and Popeo, PC
2018-5262 07/02/2018 Emma Best
2018-5263 07/02/2018 Marianna Beauty

2018-5265 07/02/2018 (DICE)
2018-5266 07/02/2018 FDAZILLA
2018-5267 07/02/2018 FOI Services, Inc.
2018-5268 07/02/2018 FOIA GROUP INC

2018-5269 07/02/2018 Regulatory Professionals Inc.
2018-5270 07/02/2018 Rachel B. Goldberg M.D.

2018-5272 07/02/2018 PATTERSON BELKNAP WEBB & TYLER
2018-5273 07/02/2018 Avanti Polar Lipids, Inc.

2018-5274 07/02/2018 FOI Services, Inc.
2018-5275 07/02/2018 FOI Services, Inc.

2018-5276 07/02/2018 FOI Services, Inc.
2018-5277 07/02/2018 Brandon Neuschafer, Bryan Cave Leighton Paisner

2018-5278 07/02/2018 FOI Services, Inc.
2018-5279 07/02/2018 MicroVention, Inc.
2018-5280 07/02/2018 FOI Services, Inc.
2018-5281 07/02/2018 FDAZILLA
2018-5282 07/02/2018 FOI Services, Inc.

2018-5284 07/02/2018 FOI Services, Inc.
2018-5285 07/02/2018 VLP Law Group LLP



Brigham and Women's Hospital, Division of
2018-53 01/03/2018 Pharmacoepidemiology and Pharmacoeconomics
2018-5301 07/02/2018 Francoeur Law Office
2018-5302 07/02/2018 FOI Services, Inc.
2018-5303 07/02/2018 FOI Services, Inc.

2018-5304 07/02/2018 Arthrec, Inc.
2018-5305 07/02/2018 FOI Services, Inc.

2018-5306 07/02/2018 GORDON & REES LLP
2018-5307 07/02/2018 FOI Services, Inc.
2018-5308 07/02/2018 INNOVATIVE STERILIZATION TECHNOLOGIES

2018-5309 07/02/2018 UNIVERSITY OF CALIFORNIA, DAVIS
2018-531 01/19/2018 FDA NEWS
2018-5310 07/02/2018 BAKER STERCHI COWDEN & RICE LLC
2018-5311 07/02/2018 KREIG, BARBARA A
2018-5312 07/02/2018 DAVIS WRIGHT TREAMAINE LLP

Rantisi Inc. (DBA) I&J Trucking Harbor Container
2018-5313 07/02/2018 Services
2018-5314 07/02/2018 WILLIAM K GAMBLE LAW FIRM
2018-5315 07/02/2018 REGULATORY COMPLIANCE ASSOCIATES INC
2018-5316 07/02/2018 FOIA GROUP INC
2018-5317 07/02/2018 HARE WYNN NEWELL & NEWTON LLP

2018-532 01/19/2018 FOI Services, Inc.
2018-5320 07/02/2018 NAPOLI SHKOLNIK PLLC
2018-5321 07/02/2018 NAPOLI SHKOLNIK PLLC
2018-5322 07/03/2018 T. Rowe Price
2018-5323 07/03/2018 VLP Law Group LLP
2018-5324 07/03/2018 VLP Law Group LLP
2018-5325 07/03/2018 FOI Services, Inc.

2018-5326 07/03/2018 FOIA GROUP INC
2018-5328 07/03/2018 Shehadeh Giannamore PLLC
2018-5329 07/03/2018 Gleam Law, PLLC

2018-5330 07/03/2018 FOI Services, Inc.
2018-5331 07/03/2018 KING & SPALDING
2018-5332 07/03/2018 KING & SPALDING

2018-5333 07/03/2018 Da Shi
2018-5334 07/03/2018 CEDARS-SINAI MEDICAL CENTER
2018-5336 07/03/2018 FDAAWARE

2018-5337 07/03/2018 MicroVention, Inc.
2018-5338 07/03/2018 VLP Law Group LLP


2018-5341 07/03/2018 Athenex, Inc.
2018-5346 07/03/2018 AABB

2018-5348 07/03/2018 knoell USA, LLC
2018-5349 07/03/2018 MEDTRONIC
2018-5350 07/03/2018 Amador, Richard M

2018-5351 07/03/2018 Margo McCreary
2018-5352 07/03/2018 FDAZILLA
2018-5353 07/03/2018 China National Seed Group Co., LTD

2018-5354 07/03/2018 Syndax Pharmaceuticals, Inc.
2018-5358 07/03/2018 FOI Services, Inc.
2018-5362 07/03/2018 FOI Services, Inc.
2018-5366 07/03/2018 FOI Services, Inc.
2018-5370 07/03/2018 FDA NEWS
2018-5371 07/03/2018 FOI Services, Inc.
2018-5376 07/03/2018 FDA NEWS
2018-5377 07/03/2018 FOI Services, Inc.
2018-538 01/19/2018 FOI Services, Inc.
2018-5382 07/03/2018 FDA NEWS
2018-5383 07/03/2018 FOI Services, Inc.
2018-5384 07/03/2018 FOI Services, Inc.
2018-5388 07/05/2018 Carlos Murguia
2018-5389 07/05/2018 Susan Devick

2018-5390 07/05/2018 Marinus Pharmaceuticals, Inc.
2018-5392 07/05/2018 Katharine pierson

2018-5393 07/05/2018 Kaitlyn Lentz
2018-5394 07/05/2018 i-Sep
2018-5395 07/05/2018 HARPER'S MAGAZINE
2018-5396 07/05/2018 Hugh L. Koerner, P.A.
2018-54 01/03/2018 FOI Services, Inc.

2018-5400 07/05/2018 Quidel Cardiovascular Inc.
2018-5401 07/05/2018 ELI LILLY & CO
2018-5402 07/05/2018 NTK Network

2018-5403 07/05/2018 Cozen O'Connor, Attn.: Ryan P. Bottegal
2018-5404 07/05/2018 VENABLE LLP
2018-5405 07/05/2018 Susan Night
2018-5406 07/05/2018 Woolls Peer Dollinger & Scher
2018-5407 07/05/2018 Jesse Alaniz

2018-5409 07/05/2018 FiercePharma


2018-5413 07/05/2018 ARKEMA INC
2018-5414 07/05/2018 Cozen O'Connor Attn.: Ryan P. Bottegal
2018-5415 07/05/2018 Patheon UK Limited

2018-5418 07/05/2018 Schepens Eye Research Institute
2018-542 01/19/2018 FOI Services, Inc.

2018-5424 07/05/2018 Pashman Stein Walder Hayden, PC
2018-5425 07/05/2018 Nomura Securities

2018-5426 07/05/2018 ARTHREX, INC.
2018-5427 07/05/2018 ARTHREX, INC.
2018-5428 07/05/2018 MA Silva USA
2018-5429 07/05/2018 FOI Services, Inc.

2018-5432 07/05/2018 FOI Services, Inc.

2018-5433 07/05/2018 Doe J

2018-5435 07/05/2018 GI View Ltd.
2018-5436 07/05/2018 FDAZILLA
2018-5437 07/05/2018 WESTERN UNIVERSITY
2018-5439 07/05/2018 WESTERN UNIVERSITY
2018-5440 07/05/2018 DCCC
2018-5441 07/05/2018 ATTORNEY GENERAL OF FLORIDA
2018-5443 07/05/2018 IPSEN BIOPHARMACEUTICALS INC

2018-5446 07/06/2018 Richard Fairgrieve
2018-5447 07/06/2018 Hawley Troxell
Brigham and Women's Hospital / Harvard Medical
2018-5448 07/06/2018 School
2018-5449 07/06/2018 HuffPost
2018-545 01/23/2018 Stephen Martin
2018-5450 07/06/2018 FOI Services, Inc.
2018-5451 07/06/2018 FOI Services, Inc.
2018-5452 07/06/2018 Law Office of Michael Goodman,PC
2018-5453 07/06/2018 FOI Services, Inc.
2018-5454 07/06/2018 FOI Services, Inc.
2018-5455 07/06/2018 Lotus Research, LLC

2018-5456 07/06/2018 Daniel & Daniel Consulting, LLC
2018-5457 07/06/2018 FDAZILLA
2018-5458 07/06/2018 FDAZILLA
2018-5459 07/06/2018 Medical Device Academy
2018-546 01/23/2018 CNA

2018-5463 07/06/2018 FOI Services, Inc.
2018-5464 07/06/2018 FOI Services, Inc.
2018-5466 07/06/2018 Nugeri LLC
2018-5467 07/06/2018 Milan George
2018-5468 07/06/2018 FOI Services, Inc.
2018-5469 07/06/2018 Vikas Khurana

2018-5471 07/06/2018 Rochal Industries
2018-5472 07/06/2018 Ethypharm USA Corp
2018-5473 07/06/2018 Meitheal Pharmaceuticals Inc

2018-5474 07/06/2018 Morgan Stanley
2018-5476 07/06/2018 Vyaire Medical
2018-5477 07/06/2018 FDAZILLA
2018-5478 07/06/2018 ALKERMES
2018-5479 07/06/2018 Rise Baking Company
2018-548 01/23/2018 Symbioteq
2018-5482 07/06/2018 Medial Device Academy
2018-5483 07/06/2018 Vyaire Medical
2018-5489 07/06/2018 Carlos Murguia

2018-549 01/23/2018 BALYASNY ASSET MANAGEMENT
2018-5490 07/09/2018 BLOOMBERG NEWS

2018-5491 07/09/2018 Power Rogers & Smith, LLP

2018-5493 07/09/2018 STANFORD UNIVERSITY SCHOOL OF MEDICINE
2018-5494 07/09/2018 Janica Alvarez
2018-5495 07/09/2018 OLYMPUS CORPORATION OF THE AMERICAS

2018-5496 07/09/2018 FOI Services, Inc.
2018-5497 07/09/2018 FOI Services, Inc.
2018-55 01/03/2018 Scopia Capital
2018-5501 07/09/2018 Power Rogers & Smith, LLP

2018-5502 07/09/2018 FOIA GROUP INC
2018-5504 07/09/2018 RegCon Solutions, LLC
2018-5509 07/09/2018 MAGNETAR CAPITAL

2018-5510 07/09/2018 Algorithme Pharma USA

2018-5511 07/09/2018 FOI Services, Inc.
2018-5512 07/09/2018 Cook Medical
2018-5513 07/09/2018 University at Buffalo (SUNY) History Department

2018-5514 07/09/2018 FDAAWARE
2018-5516 07/09/2018 Evan Anderson
2018-5517 07/09/2018 Onbix Corporation
2018-5518 07/09/2018 Chattem Inc

2018-5519 07/09/2018 FOI Services, Inc.
2018-5520 07/09/2018 Morning Consult

2018-5522 07/09/2018 scott present
2018-5523 07/09/2018 Rochal Industries
2018-5524 07/09/2018 FOI Services, Inc.
2018-5525 07/09/2018 Janica Alvarez
2018-5527 07/09/2018 MCNEELY STEPHENSON
2018-5528 07/09/2018 Iris Hewlett
2018-5529 07/09/2018 Iris Hewlett

Sanford Burnham Prebys Medical Discovery
2018-553 01/23/2018 Institute
2018-5530 07/09/2018 Anthony Roberts
2018-5531 07/09/2018 lisa douglass

2018-5532 07/09/2018 Doe J
2018-5533 07/09/2018 Morning Consult
2018-5534 07/09/2018 Rise Baking Company
2018-5536 07/09/2018 Rudolf Storz GmbH
2018-5537 07/09/2018 Intermountain Healthcare
2018-5538 07/09/2018 Mary Wilber

2018-5539 07/09/2018 BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
2018-554 01/23/2018 RAY THOMPSON
2018-5540 07/09/2018 Huazhong Agricultural University
2018-5543 07/09/2018 Natural Products Association
2018-5544 07/09/2018 FDA Aerospace Solutions
2018-5545 07/09/2018 CAPITOL FORUM
2018-5546 07/09/2018 CAPITOL FORUM
2018-5547 07/09/2018 FOI Services, Inc.

2018-5548 07/10/2018 FDAAWARE

2018-555 01/23/2018 Susan Devick
2018-5550 07/10/2018 Botswana University of Science and Technology

2018-5554 07/10/2018 Emma Best

2018-5555 07/10/2018 FDAAWARE
2018-5556 07/10/2018 Percussionaire Corporation
2018-5557 07/10/2018 Spruce Point Capital Management

2018-5558 07/10/2018 Raymond James
2018-556 01/23/2018 Iowa Public Radio

2018-5560 07/10/2018 FDAAWARE
2018-5561 07/10/2018 BLOOMBERG NEWS

2018-5563 07/10/2018 Protech Pharmaservices Corporation,Taiwan
2018-5564 07/10/2018 Iris Hewlett

2018-5565 07/10/2018 Jeremy Borden
2018-5566 07/10/2018 Jeremy Borden
2018-5567 07/10/2018 Ellex Medical Pty Ltd
2018-5568 07/10/2018 Makro Technologies Inc.
2018-5569 07/10/2018 JUDGE ROTENBERG CENTER

2018-557 01/23/2018 FOIA GROUP INC
2018-5570 07/10/2018 Doe J
2018-5573 07/11/2018 FDAZILLA
2018-5574 07/11/2018 FDAZILLA
2018-5575 07/11/2018 FDAZILLA

2018-5576 07/11/2018 Mary Dickson
2018-5577 07/11/2018 Permobil, Inc
2018-5578 07/11/2018 Paskowitz Law Firm PC

2018-558 01/23/2018 Hood River Distillers, Inc.
2018-5580 07/11/2018 ENVIRONMENTAL WORKING GROUP

2018-5581 07/11/2018 Ossio Ltd.
2018-5582 07/11/2018 Registrar Corp
2018-5583 07/11/2018 ZS Associates Pvt. Ltd.

2018-5584 07/11/2018 ConMed Corporation
2018-5586 07/11/2018 Arent Fox, LLP
2018-5587 07/11/2018 WATERS & KRAUS LLP

2018-5588 07/11/2018 Andrew Pitkoff
2018-559 01/23/2018 Sam Edland
2018-5590 07/11/2018 FDA NEWS

2018-5591 07/11/2018 WIRED NEWS
2018-5592 07/11/2018 Applied Medical
2018-5593 07/11/2018 Anthony Roberts
2018-5594 07/11/2018 Best Maid Cookie Company

2018-5595 07/11/2018 Turnage Law Office
2018-5596 07/11/2018 FOI Services, Inc.
2018-5598 07/11/2018 FDAZILLA
2018-5599 07/11/2018 FDAZILLA

2018-56 01/03/2018 Mark Schafer
2018-5600 07/11/2018 FDAZILLA
2018-5601 07/11/2018 FDAZILLA

2018-5603 07/11/2018 FDA NEWS
2018-5604 07/11/2018 Richard Wolf Medical Instruments Corporation

2018-5605 07/11/2018 TF Health Co.
2018-5606 07/11/2018 sophie zhao
2018-5609 07/11/2018 PROCTER AND GAMBLE

2018-561 01/23/2018 FOI Services, Inc.
2018-5610 07/11/2018 Fairview Pharmacy Services, LLC

2018-5611 07/11/2018 Glendale Warehouse & Distribution Corp.
2018-5612 07/11/2018 Milan George
2018-5613 07/11/2018 Krista Angell
2018-5614 07/11/2018 INTERTEK
2018-5615 07/11/2018 INTERTEK
2018-5616 07/12/2018 Crabbe Brown and James
2018-5617 07/12/2018 FDAZILLA

2018-5619 07/12/2018 FDAZILLA
2018-562 01/23/2018 Nutrasource Diagnostics Inc.
2018-5620 07/12/2018 FDAZILLA
2018-5621 07/12/2018 FDAZILLA
2018-5622 07/12/2018 FDAZILLA
2018-5623 07/12/2018 FOOD SAFETY NEWS
2018-5625 07/12/2018 FDAZILLA

2018-5626 07/12/2018 Gerardine Drummond
2018-5627 07/12/2018 FOIA GROUP INC

2018-5629 07/12/2018 FOI Services, Inc.
2018-563 01/23/2018 WSDA: Food Safety and Consumer Services

2018-5630 07/12/2018 MUCKROCK
2018-5631 07/12/2018 JABURG & WILK PC

2018-5632 07/12/2018 Omron Healthcare, Inc.
2018-5633 07/12/2018 Doe J
2018-5634 07/12/2018 KOAA-TV NBC 5

2018-5635 07/12/2018 Doe J
2018-5636 07/12/2018 Doe J
2018-5638 07/12/2018 UNITE HERE

2018-5639 07/12/2018 Francis Yomi
2018-5642 07/12/2018 EIH Services

2018-5647 07/12/2018 USA TODAY

2018-5649 07/12/2018 Kico Knee Innovation Company
2018-5650 07/12/2018 Hudson Baking Company

2018-5656 07/13/2018 Innominata dba GenBio
2018-5667 07/13/2018 The Cancer Letter
2018-5668 07/13/2018 FOI Services, Inc.
2018-5669 07/13/2018 Morton Grove Pharmaceuticals, Inc.
2018-5670 07/13/2018 GIBSON DUNN & CRUTCHER LLP

2018-5673 07/13/2018 HALL, GRETCHEN
2018-5674 07/13/2018 ADAMS AND REESE LLP

2018-5675 07/13/2018 Doe J

2018-5677 07/13/2018 CENTER FOR SCIENCE IN THE PUBLIC INTEREST
2018-5678 07/16/2018 Schumann Rosenberg

2018-568 01/23/2018 GOJO Industries, Inc.
2018-5680 07/16/2018 National Stem Cell Foundation
2018-5681 07/16/2018 FDAZILLA
2018-5682 07/16/2018 Cytokinetics, Inc.

2018-5683 07/16/2018 University of California, Santa Barbara
2018-5684 07/16/2018 Iris Hewlett

2018-5687 07/16/2018 Deven Sanon

2018-5689 07/16/2018 WATERS & KRAUS LLP
2018-569 01/23/2018 University of Southern Califoria
2018-5690 07/16/2018 KNOWLES, ARLOA A
2018-5691 07/16/2018 Samy Hamdouche

2018-5696 07/16/2018 UNIVERSITY OF CALIFORNIA, SAN FRANCISCO

2018-5697 07/16/2018 Doe J
2018-5698 07/16/2018 Registrar Corp

2018-57 01/03/2018 Mark Schafer

2018-5701 07/16/2018 Michael Russell
2018-5703 07/16/2018 ARTHREX, INC.
2018-5704 07/16/2018 UroGen Pharma
2018-5706 07/16/2018 Tran, Loan

2018-5707 07/16/2018 Eywa Pharma Inc.
2018-571 01/23/2018 Technology Sciences Group Inc.
2018-5710 07/16/2018 GARY F FRANKE CO LPA

2018-5713 07/16/2018 MedCity News
2018-5714 07/16/2018 Jonas Gulmez
2018-5716 07/16/2018 The Center for Investigative Reporting

2018-5717 07/16/2018 Dr. James Harper
2018-5718 07/16/2018 Roswell Park Comprehensive Cancer Center

2018-5720 07/16/2018 CAPITOL FORUM
2018-5721 07/16/2018 CHAMP #168896, SEAN PHILLIP
2018-5722 07/16/2018 Rivkin Radler LLP
2018-5723 07/16/2018 FOI Services, Inc.
2018-5724 07/16/2018 Dr Ajay Phadke

2018-5726 07/16/2018 ARTHREX, INC.
2018-5727 07/16/2018 KEYS 22458-017, CLAY
2018-5728 07/16/2018 UNITE HERE LOCAL 23

2018-5729 07/16/2018 Doe J
2018-573 01/23/2018 Huvepharma, Inc.
2018-5730 07/16/2018 Doe J

2018-5734 07/17/2018 ARTHREX, INC.
2018-5735 07/17/2018 Doe J
2018-5736 07/17/2018 UroGen Pharma
2018-5737 07/17/2018 FDAAWARE
2018-5738 07/17/2018 FDAAWARE
2018-5739 07/17/2018 MEDTRONIC, INC.
2018-574 01/23/2018 Darsana Capital Partners
2018-5740 07/17/2018 Migliaccio & Rathod LLP

2018-5741 07/17/2018 FOI Services, Inc.

2018-5743 07/17/2018 FOIA GROUP INC
2018-5744 07/17/2018 FOI Services, Inc.

2018-5745 07/17/2018 Wiley Robinson
2018-5746 07/17/2018 Gavigan, Frances A
2018-5748 07/17/2018 FOI Services, Inc.
2018-5749 07/17/2018 FOI Services, Inc.

2018-5752 07/17/2018 FOI Services, Inc.
2018-5753 07/17/2018 Kenneth Emmer
2018-5755 07/17/2018 Zoetis Inc.
2018-5756 07/17/2018 Hogan Lovells
2018-5759 07/17/2018 Gauss Surgical
2018-576 01/23/2018 The MCS Group, Inc.

2018-5762 07/17/2018 Wegmans Food Markets, Inc.
2018-5763 07/17/2018 TODD & WELD LLP
2018-5764 07/17/2018 KOELLER, NEBEKER, CARLSON & HALUCK LLP

2018-5765 07/17/2018 Doe J
2018-5766 07/17/2018 WASHINGTON STATE UNV CARSON COLLEGE OF BUSINESS

2018-5767 07/18/2018 Advanced Medical Solutions Ltd
2018-5768 07/18/2018 TRACOE medical GmbH
2018-577 01/23/2018 FOIA GROUP INC
2018-5770 07/18/2018 physIQ Inc
2018-5771 07/18/2018 Zachary Frey

2018-5772 07/18/2018 Allergan, Inc.

2018-5775 07/18/2018 Theresa Welu

2018-5779 07/18/2018 FOI Services, Inc.
2018-578 01/23/2018 Athenex, Inc.
2018-5780 07/18/2018 FOI Services, Inc.
2018-5783 07/18/2018 FOI Services, Inc.
2018-5784 07/18/2018 FOI Services, Inc.
2018-5785 07/18/2018 JENNIFER GERARD
2018-5786 07/18/2018 Matthew Haberkorn

2018-5787 07/18/2018 Nexus Pharmaceuticals, Inc.

2018-5789 07/18/2018 Private Limited
2018-579 01/23/2018 FOIA GROUP INC
2018-5790 07/18/2018 Presbyterian College School of Pharmacy
2018-5791 07/18/2018 Nugeri LLC
2018-5792 07/18/2018 Nugeri LLC
2018-5793 07/18/2018 Jason A Jensen
2018-5794 07/18/2018 Kunal Randeria

2018-5796 07/18/2018 Jigsaw Productions
2018-5798 07/18/2018 Grant Beaty

2018-5799 07/18/2018 CROOK, DAVID
2018-58 01/03/2018 Alliance for Aging, Delia Keen

2018-5800 07/18/2018 MYLAN INC

2018-5809 07/18/2018 FDA NEWS
2018-5810 07/18/2018 FDA NEWS
2018-5813 07/18/2018 FOI Services, Inc.
2018-5814 07/18/2018 FOI Services, Inc.
2018-5815 07/18/2018 FOI Services, Inc.
2018-5816 07/18/2018 FOI Services, Inc.
2018-582 01/23/2018 FOI Services, Inc.
2018-5821 07/19/2018 Darla J Hall

2018-5822 07/19/2018 Jigsaw Productions
2018-5823 07/19/2018 Kunal Randeria
2018-5824 07/19/2018 Kunal Randeria
2018-5825 07/19/2018 Kunal Randeria

2018-5826 07/19/2018 FDAZILLA
2018-5827 07/19/2018 Chris Ellen Bliven
2018-5829 07/19/2018 FOOD SAFETY NEWS

2018-583 01/23/2018 FOI Services, Inc.
2018-5830 07/20/2018 Presbyterian College School of Pharmacy
2018-5831 07/20/2018 Teva Pharmacueticals
2018-5832 07/20/2018 BLOOMBERG NEWS
Institut national d'excellence en santé et en

2018-5833 07/20/2018 services sociaux
2018-5835 07/20/2018 Lacey Manufacturing Company LLC

2018-5836 07/20/2018 Holman Law PLLC
2018-5837 07/20/2018 AP ASSOCIATED PRESS
2018-584 01/23/2018 Biowy Corporation
2018-5840 07/20/2018 Vox
2018-5841 07/20/2018 Ms.
2018-5842 07/20/2018 Quick-Med Technologies, Inc.
2018-5843 07/20/2018 Braeburn Pharmceuticals

2018-5844 07/20/2018 GRAS Associates, LLC.
2018-5845 07/23/2018 FOI Services, Inc.
2018-5846 07/23/2018 FDAZILLA
2018-5847 07/23/2018 Teligent Pharma, Inc.
2018-5848 07/23/2018 FDAZILLA
2018-5849 07/23/2018 FDAZILLA

2018-585 01/23/2018 FOI Services, Inc.
2018-5850 07/23/2018 FDAZILLA

2018-5851 07/23/2018 FDAZILLA
2018-5852 07/23/2018 Diverstech Co.

2018-5853 07/23/2018 Houston Methodist Hospital
2018-5854 07/23/2018 Melanie Mann
2018-5855 07/23/2018 Cuneo Gilbert & LaDuca, LLP
2018-5856 07/23/2018 SunGen Pharma LLC
2018-5857 07/23/2018 Gusmer Enterprises Inc

2018-5858 07/23/2018 FOI Services, Inc.
2018-5859 07/23/2018 Medicure Inc.

2018-5861 07/23/2018 BURDOCK GROUP

2018-5862 07/23/2018 Anthony Roberts
2018-5863 07/23/2018 Rieders Travis Law Firm

2018-5866 07/23/2018 Laura Walthew
2018-5867 07/23/2018 Texas A&M University School of Law
2018-5868 07/23/2018 Institut d’Excellence en Santé et Service sociaux

2018-5869 07/23/2018 Bloom Tree Partners
2018-587 01/23/2018 OrthoSensor, Inc.

2018-5870 07/23/2018 physIQ Inc
2018-5871 07/23/2018 GE Healthcare

2018-5872 07/23/2018 i-Sep
2018-5873 07/23/2018 Virbac Corporation
2018-5874 07/23/2018 PFIZER INC
2018-5875 07/23/2018 Centaur Pharmaceuticals Pvt. Ltd.
2018-5876 07/23/2018 Haffner Associates
2018-5877 07/23/2018 Peter Breggin, MD
2018-5878 07/23/2018 ABBOTT
2018-5879 07/23/2018 HERNAN ROJAS
2018-588 01/23/2018 Helen Ash
2018-5880 07/23/2018 Manresa FDA Consulting, LLC
2018-5881 07/23/2018 Informa

2018-5882 07/23/2018 FOIA GROUP INC
2018-5883 07/23/2018 FOIA GROUP INC
2018-5884 07/23/2018 MedoPlast LLC

2018-5885 07/23/2018 BECTON DICKINSON
2018-5886 07/23/2018 Dawn Firsing-Paris
2018-5887 07/23/2018 AIRON CORPORATION
2018-5888 07/23/2018 BLOOMBERG NEWS
2018-589 01/23/2018 Marsh, Rickard & Bryan, P.C.
2018-5890 07/23/2018 Wakefern Food Corporation

2018-5893 07/23/2018 DANIEL & ASSOCIATES LLC
2018-5894 07/23/2018 Dysart Law Firm, PC
2018-5895 07/23/2018 BARNES & THORNBURG LLP

2018-5896 07/23/2018 Doe J
2018-5897 07/23/2018 Brutus, Gesuclais
2018-5898 07/23/2018 Doe J

2018-590 01/23/2018 STAT
2018-5900 07/23/2018 LIEBER-UST, MANUELA L
2018-5901 07/23/2018 Doe J

2018-5903 07/23/2018 GARDNER 6643244, GORDON

2018-5904 07/23/2018 FDAZILLA
2018-5905 07/24/2018 Ghost Tree Capital

2018-5906 07/24/2018 physIQ Inc
2018-5907 07/24/2018 physIQ Inc
2018-5908 07/24/2018 FINANCIAL TIMES
2018-5909 07/24/2018 Buzzfeed News

2018-591 01/23/2018 Katie Eckert
2018-5910 07/24/2018 physIQ Inc
2018-5911 07/24/2018 Moab Partners
2018-5912 07/24/2018 Buzzfeed News

2018-5913 07/24/2018 Marie Maurice
2018-5914 07/24/2018 HAMILTON MEDICAL AG
2018-5915 07/24/2018 JOHNSON BECKER PLLC



2018-5921 07/24/2018 FOI Services, Inc.
2018-5922 07/24/2018 FOIA GROUP INC
2018-5923 07/24/2018 FOIA GROUP INC
2018-5924 07/24/2018 AABB
2018-5925 07/24/2018 FOI Services, Inc.

2018-5926 07/24/2018 Pacira Pharmaceuticals, Inc.
2018-5927 07/24/2018 Boston Business Journal
2018-5928 07/24/2018 Olly PBC

2018-5929 07/24/2018 Cathy Craft
2018-5930 07/24/2018 Kristin Wise
2018-5931 07/24/2018 Houston Methodist Hospital
2018-5932 07/24/2018 RAY THOMPSON


2018-5936 07/25/2018 Arent Fox, LLP



2018-5948 07/25/2018 Provetica Animal Health
2018-5950 07/25/2018 FOI Services, Inc.

2018-5951 07/25/2018 Infinium Medical, Inc.

2018-5953 07/25/2018 Coltène/Whaledent GmbH +Co. KG
2018-5954 07/25/2018 Kevin Corrigan Consulting
2018-5955 07/25/2018 Paynter Law Firm
2018-5956 07/25/2018 BUSINESS 360 INC

2018-5957 07/25/2018 CASMED MEDICAL SYSTEMS INC
Rantisi Inc. (DBA) I&J Trucking Harbor Container
2018-5958 07/25/2018 Services
2018-5959 07/25/2018 REUTERS
2018-596 01/23/2018 Doe J
2018-5960 07/25/2018 Iris Hewlett

2018-5961 07/25/2018 FSM LEASING SERVICES LLC
2018-5965 07/25/2018 HELLMUTH & JOHNSON PLLC

2018-597 01/23/2018 JUDICIAL WATCH


2018-6 01/02/2018 Doe J

2018-600 01/23/2018 WALSON G65198, SILUS
2018-601 01/23/2018 MUCKROCK NEWS


2018-6016 07/26/2018 Kohl Harrington

2018-6018 07/26/2018 Nancy Silverman

2018-602 01/23/2018 SAFE HAVEN BABY BOXES
2018-6025 07/26/2018 Wolf Haldenstein Adler Freeman & Herz LLC

2018-6027 07/26/2018 FOIA GROUP INC
2018-6028 07/26/2018 Ted Bei
2018-6029 07/26/2018 Ted Bei

2018-603 01/23/2018 JANET LINDNER SPIELBERG LAW OFC
2018-6030 07/26/2018 Ted Bei
2018-6031 07/26/2018 Daniel Astone

2018-6032 07/26/2018 NATIONWIDE CHILDREN'S HOSPITAL
2018-6033 07/26/2018 Doe J

2018-604 01/23/2018 JONES DAY




2018-6049 07/26/2018 lori silverstein

2018-6050 07/27/2018 Denio Lourenco
2018-6051 07/27/2018 FOI Services, Inc.

2018-6052 07/27/2018 REGCON Solutions LLC
2018-6053 07/27/2018 FDAAWARE
2018-6054 07/27/2018 Relypsa, Inc.
2018-6055 07/27/2018 Sanford Health Hospital Pharmacy

2018-6056 07/27/2018 GW Cancer Center
2018-6057 07/27/2018 Gland Pharma Limitd
2018-6059 07/27/2018 Supportive-Family
2018-606 01/23/2018 GLAWE, JUSTIN
2018-6060 07/27/2018 the Wood Burditt group
2018-6061 07/27/2018 THOMSON REUTERS

2018-6062 07/27/2018 THOMSON REUTERS
North Carolina State University, Dept. of
2018-6064 07/30/2018 Agricultural and Resource Economics

2018-6069 07/30/2018 LEE AND XIAO
2018-6070 07/30/2018 Adams Flavors, Foods & Ingredients

2018-6072 07/30/2018 Annette Graham

2018-6073 07/30/2018 FDA NEWS
2018-6074 07/30/2018 FOI Services, Inc.
2018-6079 07/30/2018 FDA NEWS

2018-6080 07/30/2018 FOI Services, Inc.
2018-6085 07/30/2018 FOI Services, Inc.
2018-6089 07/30/2018 FOI Services, Inc.

2018-6092 07/30/2018 Synonymy

2018-6096 07/31/2018 Hutchison PLLC

2018-6097 07/31/2018 Hutchison PLLC
2018-6098 07/31/2018 Hutchison PLLC
2018-6099 07/31/2018 Hutchison PLLC

2018-610 01/23/2018 STERIS CORP
2018-6100 07/31/2018 Hutchison PLLC
2018-6102 07/31/2018 MASSACHUSETTS INSTITUTE OF TECHNOLOGY
2018-6103 07/31/2018 Hutchison PLLC

2018-6104 07/31/2018 ClaritySpring Inc
2018-6105 07/31/2018 Peter Lasek
2018-6106 07/31/2018 Nicole Rosen

2018-6110 08/01/2018 FOI Services, Inc.


2018-6116 08/01/2018 ROCHEM INTERNATIONAL INC
2018-6118 08/01/2018 Magnolia Medical Technologies

2018-6119 08/01/2018 FDAZILLA
2018-6120 08/01/2018 Shire : Attn Taiwo Omolodun
2018-6121 08/01/2018 RAY THOMPSON
2018-6122 08/01/2018 RAY THOMPSON
2018-6123 08/01/2018 RAY THOMPSON
2018-6124 08/01/2018 Fletcher, Edward J

2018-6125 08/01/2018 Innovacyn, Inc.
2018-6127 08/01/2018 Mary Baude
2018-6128 08/01/2018 Lortscher Animal Nutrition, Inc.
2018-6129 08/01/2018 Bzada
2018-613 01/23/2018 MARINA BIOTECH

2018-6130 08/01/2018 Bzada
2018-6131 08/01/2018 Registrar Corp

reveal from the center for investigative
2018-6132 08/01/2018 reporting
2018-6133 08/01/2018 Janssen Research & Development, LLC
2018-6134 08/01/2018 Link Bio Corp.
2018-6135 08/01/2018 Dexcom, Inc.
2018-6136 08/01/2018 Dexcom, Inc.
2018-6137 08/01/2018 Piper Access
2018-6138 08/01/2018 Karla Godinez Gonzalez

2018-6139 08/01/2018 Dr Ajay Phadke
2018-614 01/23/2018 MUCKROCK NEWS
2018-6140 08/01/2018 Jubilant DraxImage Inc.
2018-6142 08/01/2018 Good Food Institute
2018-6143 08/01/2018 ARENT FOX LLP
2018-6145 08/01/2018 Mineral Logic

2018-6146 08/01/2018 Link Bio Corp.
2018-6147 08/01/2018 Link Bio Corp.
2018-6148 08/01/2018 Mr.Terry H Capone
2018-615 01/23/2018 MUCKROCK NEWS
2018-6150 08/01/2018 Tropical Smoothie Cafe, LLC

2018-6151 08/01/2018 Celltrion, Inc.

2018-6155 08/01/2018 APCER Life Sciences, Inc.
2018-6156 08/01/2018 APM Reports/Marketplace/MPR
2018-6157 08/01/2018 Aptinyx

2018-6158 08/01/2018 Aptinyx
2018-616 01/23/2018 MUCKROCK NEWS
2018-6161 08/01/2018 APM Reports/Marketplace/MPR
2018-6162 08/01/2018 Provetica Animal Health
2018-6164 08/01/2018 AMD MEDICOM
2018-6165 08/01/2018 Getinge Group USA, LLC

2018-6167 08/01/2018 Doe J
2018-6168 08/01/2018 PAYNE, KITTI
2018-6169 08/01/2018 Doe J
2018-617 01/24/2018 FDAAWARE

2018-6171 08/01/2018 KLEINFELD KAPLAN & BECKER
2018-6173 08/01/2018 AMERICAN BRIDGE 21ST CENTURY
2018-6174 08/01/2018 VANDERBES, JENNIFER
2018-6175 08/01/2018 Doe J
2018-6176 08/01/2018 COMPLETE LEGAL
2018-6177 08/02/2018 JOURNALISTS
2018-6179 08/02/2018 The Solomon Law Group PA
2018-618 01/24/2018 Diagnostic Group LLC DBA Grason-Stadler
2018-6180 08/02/2018 Bill and Melinda Gates Medical Research Institute
2018-6181 08/02/2018 Duke University Department of Surgery

2018-6182 08/02/2018 Peggy McLaughlin
2018-6183 08/02/2018 FDAZILLA

2018-6184 08/02/2018 FDAZILLA
2018-6185 08/02/2018 KEDPLASMA LLC
2018-6186 08/02/2018 BLOOMBERG NEWS

2018-6187 08/02/2018 Key Surgical, Inc.
2018-6188 08/02/2018 CRYOLIFE CARDIOVASCULAR/WEIL GOTSHAL MANGES
2018-6189 08/02/2018 FOI Services, Inc.

2018-619 01/24/2018 Meitheal Pharmaceuticals, Inc.
2018-6190 08/02/2018 LABORATOIRES URGO
2018-6191 08/02/2018 GETINGE CASTLE INC
2018-6194 08/02/2018 FOI Services, Inc.

2018-6196 08/02/2018 FOI Services, Inc.
2018-6197 08/02/2018 FDA NEWS
2018-6198 08/02/2018 FDA NEWS

2018-6199 08/02/2018 Henkel Corporation
2018-62 01/03/2018 B&H Cionsulting Services, Inc.

2018-620 01/24/2018 PROJECT ON GOVERNMENT OVERSIGHT

2018-6201 08/02/2018 STRYKER SUSTAINABILITY SOLUTIONS

2018-6203 08/02/2018 JOURNALISTS
2018-6204 08/02/2018 FLEMING NOLEN & JEZ LLP
2018-6205 08/02/2018 Victoria M Negron
2018-6208 08/02/2018 Terri McGregor
2018-6209 08/02/2018 Quinn Eastman
2018-621 01/24/2018 CAM
2018-6210 08/02/2018 Doe J
2018-6211 08/02/2018 Doe J
2018-6212 08/02/2018 FDAZILLA

2018-6215 08/02/2018 Truth Initiative
2018-6217 08/02/2018 BAGSHAW 231613, EDWARD
2018-6218 08/02/2018 DELEON 96A6822, ERIC
2018-6219 08/02/2018 RADIO CANADA
2018-622 01/24/2018 SSM Health St Clare Hospital
2018-6220 08/02/2018 KAREN MARTIN

2018-6226 08/03/2018 Drexel University
2018-6227 08/03/2018 Mari Yonomoto
2018-6228 08/03/2018 NOVEN PHARMACEUTICALS INC

2018-6229 08/03/2018 D Sanon
2018-623 01/24/2018 Dr Ajay Phadke
2018-6230 08/03/2018 Verena von Dehn

2018-6233 08/03/2018 Teva Pharmaceuticals R&D, Inc
2018-6234 08/03/2018 Mari Yonomoto
2018-6235 08/03/2018 Mari Yonomoto

2018-6236 08/03/2018 Dr Ajay Phadke
2018-6237 08/03/2018 FITZPATRICK, CELLA, HARPER & SCINTO

2018-6238 08/03/2018 (DICE)
2018-6239 08/03/2018 AMGEN, INC.
2018-6240 08/03/2018 FOI Services, Inc.
2018-6241 08/03/2018 FOI Services, Inc.
2018-6242 08/03/2018 FDAZILLA
2018-6243 08/03/2018 Mari Yonomoto
2018-6244 08/06/2018 JOHNSON #JS-6478, AQUIL
2018-6246 08/06/2018 Human Predictions LLC
2018-6247 08/06/2018 Pat Anson
2018-6248 08/06/2018 NBC Owned & Operated Television Stations Websites

2018-6249 08/06/2018 Pat Anson
2018-625 01/24/2018 Brown, Julie
2018-6251 08/06/2018 Shed Media
2018-6252 08/06/2018 Sun Chlorella USA Corp.
2018-6253 08/06/2018 FOOD SAFETY NEWS
2018-6254 08/06/2018 JOHNSON BECKER PLLC

2018-6255 08/06/2018 Cook Medical
2018-6257 08/06/2018 BLOOMBERG NEWS
2018-6258 08/06/2018 REGULATORY AFFAIRS PROFESSIONAL SOCIETY

2018-626 01/24/2018 Pyros Pharma

2018-6261 08/06/2018 FOI Services, Inc.
2018-6262 08/06/2018 HURLEY CONSULTING ASSOCIATES LTD
2018-6263 08/06/2018 FOI Services, Inc.
2018-6264 08/06/2018 Matrix Surgical USA
2018-6265 08/06/2018 Thomas Keel & Laird, LLC

2018-6266 08/06/2018 TODD & WELD LLP
2018-6267 08/06/2018 MID Labs, Inc.
2018-6268 08/06/2018 FAIRWARNING.ORG
2018-6269 08/06/2018 FDAAWARE
2018-627 01/24/2018 Beardsley Law pllc
2018-6270 08/06/2018 FOI Services, Inc.
2018-6271 08/06/2018 Ted Bei

2018-6272 08/06/2018 REACH24H CONSULTING GROUP

2018-6274 08/06/2018 COCHLEAR AMERICAS
2018-6276 08/06/2018 Judith Silver, Esq.

2018-6277 08/06/2018 Olympus Respiratory America (ORA)/Spiration
2018-6278 08/06/2018 Buchanan Ingersoll Rooney PC

2018-6282 08/06/2018 Heather Armstrong

2018-6285 08/06/2018 Athenex, Inc.
2018-6286 08/06/2018 Bentley Biomedical Consulting, LLC
2018-6287 08/06/2018 COCHLEAR AMERICAS

2018-629 01/24/2018 International Medical Industries, Inc.

2018-6292 08/06/2018 Longeviti Neuro Solutions
2018-6293 08/06/2018 Registrar Corp

2018-6294 08/06/2018 Longeviti Neuro Solutions

2018-6297 08/06/2018 Doe J

2018-6298 08/06/2018 Doe J

2018-6300 08/06/2018 DEPACE, NICHOLAS L
2018-6301 08/06/2018 Doe J
2018-6302 08/06/2018 AYLSTOCK WITKIN KREIS & OVERHOLTZ PLLC
2018-6303 08/07/2018 FOI Services, Inc.
2018-6305 08/07/2018 Loretta Youngs

2018-6306 08/07/2018 DAEWOONG AMERICA INC
2018-6308 08/07/2018 PALL CORPORATION

2018-6309 08/07/2018 RAPS
2018-631 01/24/2018 Biocoat, Inc.
2018-6310 08/07/2018 Crawford Healthcare Ltd
2018-6311 08/07/2018 Protein Research

2018-6313 08/07/2018 MISSION PHARMACAL COMPANY/PRESIDENT

2018-6320 08/07/2018 FOI Services, Inc.

2018-6321 08/07/2018 FDAZILLA
2018-6322 08/07/2018 Doe J
2018-6323 08/07/2018 Accelerate Diagnostics, Inc.
American Red Cross Alabama and Central Gulf Coast
2018-6324 08/07/2018 Region
2018-6325 08/07/2018 Wayne Cuffley
2018-6326 08/07/2018 Vice News

2018-6327 08/07/2018 Registrar Corp


2018-6335 08/07/2018 RegCon Solutions, LLC on behalf of Substipharm
2018-6337 08/07/2018 Courante Oncology

2018-6339 08/07/2018 Judith Silver, Esq.

2018-634 01/24/2018 McGUIRE, TIMOTHY
2018-6343 08/07/2018 BUCHANAN INGERSOLL & ROONEY PC
2018-6345 08/07/2018 FDA NEWS
2018-6346 08/07/2018 FOI Services, Inc.
2018-635 01/24/2018 OHSU College of Pharmacy
2018-6351 08/07/2018 FDA NEWS
2018-6352 08/07/2018 FOI Services, Inc.
2018-6357 08/07/2018 FOI Services, Inc.
2018-6361 08/07/2018 FOIA GROUP INC
2018-6365 08/08/2018 FDAZILLA

2018-6366 08/08/2018 Registrar Corp
2018-6367 08/08/2018 OPTOVUE, INC.
2018-6368 08/08/2018 FDAZILLA

2018-6369 08/08/2018 GETINGE CASTLE INC
2018-637 01/24/2018 BLANK ROME ET AL

2018-6370 08/08/2018 JOHNSON & JOHNSON
2018-6371 08/08/2018 JOHNSON & JOHNSON
2018-6372 08/08/2018 FOI Services, Inc.
2018-6373 08/08/2018 Glenmark pharmaceutical Inc., USA
2018-6374 08/08/2018 Ghost Tree Capital

2018-6375 08/08/2018 Duffy + Partners
2018-6376 08/08/2018 Harris Teeter, LLC
2018-6377 08/08/2018 Dickinson Wright PLLC
2018-6378 08/08/2018 NovaBay Pharmaceuticals, Inc.

2018-638 01/24/2018 LINCARE INC

2018-6380 08/08/2018 Piper Access
2018-6381 08/08/2018 Mentalhealthbooks.net
2018-6382 08/08/2018 Potrero Medical
2018-6384 08/08/2018 Link Bio Corp.
2018-6385 08/08/2018 AIBMR Life Sciences, Inc.
2018-6386 08/08/2018 BARD PERIPHERAL VASCULAR INC
2018-6387 08/08/2018 Zero Point Zero Production
2018-6388 08/08/2018 Regulatory and Quality Solutions LLC

2018-639 01/24/2018 BARADAT & PABOOJIAN INC
2018-6392 08/08/2018 Smith & Nephew, Inc.

2018-6393 08/08/2018 FOI Services, Inc.
2018-6394 08/08/2018 FOI Services, Inc.

2018-6396 08/08/2018 FOI Services, Inc.
2018-6397 08/08/2018 FDAAWARE
2018-6398 08/08/2018 BLOOMBERG NEWS

2018-640 01/24/2018 LAW OFFICE OF JANET LINDNER SPIELBERG
2018-6400 08/08/2018 THE PINK SHEET

2018-6401 08/08/2018 FOI Services, Inc.
2018-6402 08/08/2018 FOI Services, Inc.
2018-6403 08/08/2018 Imangel Consulting
2018-6404 08/08/2018 FOI Services, Inc.
2018-6405 08/08/2018 FOI Services, Inc.
2018-6406 08/08/2018 FOI Services, Inc.
2018-6407 08/08/2018 FOI Services, Inc.
2018-6408 08/08/2018 FOI Services, Inc.
2018-6409 08/08/2018 Eurofins

2018-6411 08/08/2018 Webre and Associates
2018-6412 08/08/2018 PHASEBIO PHARMACEUTICALS INC

2018-6413 08/08/2018 PIERCE 163909, BRYAN
2018-6414 08/08/2018 TOUHY LAW GROUP PC
2018-6415 08/08/2018 CHEN, ANGUS

2018-6418 08/08/2018 NELSON MULLINS RILEY & SCARBOROUG
2018-6419 08/09/2018 FDAAWARE
2018-642 01/24/2018 LINCARE INC
2018-6420 08/09/2018 MITTELDEUTSCHER RUNDFUNK
2018-6421 08/09/2018 BioPharma Dive

2018-6423 08/09/2018 FDAZILLA
2018-6424 08/09/2018 Healthco.
2018-6425 08/09/2018 FDAZILLA
2018-6426 08/09/2018 FDAZILLA
2018-6427 08/09/2018 Dr Natalia Novikova
2018-6428 08/09/2018 FDAZILLA
2018-6429 08/09/2018 FDAZILLA
2018-643 01/24/2018 LINCARE INC

International Consortium for Investigative
2018-6430 08/09/2018 Journalists
2018-6431 08/09/2018 FDAZILLA
2018-6432 08/09/2018 FDAZILLA
2018-6433 08/09/2018 Dennis J. Capolongo
2018-6434 08/09/2018 Lee, KeeEun

2018-6435 08/09/2018 JOURNALISTS
2018-6436 08/09/2018 Thomas Keel & Laird, LLC

2018-6437 08/09/2018 PharmaLex US Corporation
2018-6438 08/09/2018 Principal Global Investors
2018-6439 08/09/2018 Peggy Lucero
2018-644 01/24/2018 LINCARE INC
2018-6440 08/09/2018 FDAZILLA
2018-6441 08/09/2018 FDAZILLA
2018-6442 08/09/2018 FDAZILLA
2018-6443 08/09/2018 FDAZILLA

2018-6444 08/09/2018 Pamela Parham
2018-6445 08/09/2018 FDAZILLA
2018-6446 08/09/2018 Stephen Ayers
Collaboration for Research Integrity and
2018-6447 08/09/2018 Transparency
Collaboration for Research Integrity and
2018-6448 08/09/2018 Transparency
2018-645 01/24/2018 LINCARE INC

2018-6452 08/09/2018 Pura Vida Investments
2018-6453 08/09/2018 ROCKLINE INDUSTRIES
2018-6454 08/09/2018 University of Dayton
2018-6455 08/09/2018 Leslie Wiles

2018-6457 08/09/2018 SUSSMAN, MARVIN L
2018-6458 08/09/2018 MIKART INC
2018-6459 08/09/2018 ROBERT NUTT ATTY AT LAW
2018-6461 08/10/2018 lisa douglass
2018-6462 08/10/2018 FARMOVS(Pty)Ltd

2018-6463 08/10/2018 FDAZILLA
2018-6464 08/10/2018 FDAZILLA

2018-6466 08/10/2018 FDAZILLA
2018-6467 08/10/2018 Porzio Bromberg & Newman P.C.
2018-6468 08/10/2018 FDAZILLA

2018-6469 08/10/2018 FOI Services, Inc.

2018-6470 08/10/2018 Kohichi Kajiura
2018-6471 08/10/2018 David Steinberg

2018-6472 08/10/2018 Alchem Laboratories Corporation
2018-6473 08/10/2018 ALK AMERICA INC

2018-6474 08/10/2018 WEST PHARMACEUTICAL
2018-6475 08/10/2018 Kohichi Kajiura
2018-6477 08/10/2018 FOI Services, Inc.
2018-6478 08/10/2018 RTI Surgical, Inc

2018-6481 08/10/2018 SHIRE
2018-6482 08/10/2018 FOI Services, Inc.
2018-6483 08/10/2018 Gland Pharma Limitd

2018-6484 08/10/2018 Eric Francisco
Aperture Bio, LLC (formerly Vivione Biosciences,
2018-6486 08/10/2018 LLC)
2018-6487 08/13/2018 SIEGEL BRILL PA

2018-6489 08/13/2018 Alicia Antiri
2018-649 01/25/2018 Auris Surgical Robotics, Inc.
2018-6490 08/13/2018 Alicia Antiri
2018-6491 08/13/2018 Carolina M. Wirth
2018-6492 08/13/2018 NEAVS
2018-6493 08/13/2018 OCULAR THERAPEUTIX INC

2018-6495 08/13/2018 FOI Services, Inc.
2018-6496 08/13/2018 Alicia Antiri
2018-6497 08/13/2018 Alicia Antiri
2018-6498 08/13/2018 Alicia Antiri
2018-6499 08/13/2018 NBC NEWS

2018-65 01/03/2018 Kessler Topaz Meltzer & Check, LLP
2018-6500 08/13/2018 FDAZILLA
2018-6501 08/13/2018 Alicia Antiri
2018-6502 08/13/2018 WOCKHARDT LTD
2018-6503 08/13/2018 pfm medical mepro gmbh
2018-6504 08/13/2018 Athena Kan
2018-6505 08/13/2018 Alicia Antiri

2018-6507 08/13/2018 Richard Wolf Medical Inst. Corporation
2018-6508 08/13/2018 Doe J
2018-6509 08/13/2018 Biomedical Regulatory Consulting
2018-6510 08/13/2018 Anthony Roberts

2018-6511 08/13/2018 FOI Services, Inc.
2018-6512 08/13/2018 FOI Services, Inc.
2018-6513 08/13/2018 FDAZILLA
2018-6514 08/13/2018 Senti Biosciences
2018-6515 08/13/2018 Marquez Robotic Orthopedic Institute

2018-6516 08/13/2018 Adaptimmune, LLC
2018-6517 08/13/2018 FOI Services, Inc.
2018-6518 08/13/2018 WILLIS LAW GROUP
2018-6519 08/13/2018 WILLIS LAW GROUP

2018-652 01/25/2018 Alan Walendowski
2018-6520 08/13/2018 Govzilla, Inc.
2018-6522 08/13/2018 Andrew Mallon

2018-6523 08/13/2018 Eric Francisco
2018-6524 08/13/2018 Sylvia Varnham O'Regan
University of Maryland Francis King Carey School

2018-6525 08/13/2018 of Law
2018-6526 08/13/2018 COVIDIEN
2018-6527 08/13/2018 Teleflex Medical, Inc
2018-6528 08/13/2018 FDA NEWS
2018-6529 08/13/2018 SHIRE
2018-653 01/25/2018 Novitium Pharma LLC
2018-6530 08/13/2018 BSN MEDICAL INC

2018-6531 08/13/2018 Lincoln Diagnostics, Inc.
2018-6532 08/13/2018 Minsung Kang
2018-6534 08/13/2018 Eli Lilly Canada Inc.

2018-6535 08/13/2018 White & Case LLP
2018-6536 08/13/2018 NYU Stern School of Business
2018-6537 08/13/2018 FOI Services, Inc.
2018-6541 08/13/2018 FDA NEWS
2018-6542 08/13/2018 FOI Services, Inc.
2018-6546 08/13/2018 UNITE HERE

2018-6548 08/14/2018 UVLC
2018-6549 08/14/2018 Boston Medical Products, Inc.

2018-655 01/25/2018 FOI Services, Inc.
2018-6550 08/14/2018 AFCEA Belvoir

2018-6551 08/14/2018 Alvarez & Marsal
2018-6552 08/14/2018 Syneos Health

2018-6554 08/14/2018 FOI Services, Inc.
2018-6555 08/14/2018 FOIA GROUP INC
2018-6557 08/14/2018 Retnia Inc.
2018-6558 08/14/2018 Perishables Jamaica Limited

2018-6559 08/14/2018 Doe J
2018-6560 08/14/2018 ERM
2018-6561 08/14/2018 Sylvia Varnham O'Regan
2018-6562 08/14/2018 Mirati Therapeutics, Inc

2018-6564 08/14/2018 FDAZILLA
2018-6565 08/14/2018 UVLC
2018-6566 08/14/2018 Medplast Previously known as ( Vention Medical)

2018-6567 08/14/2018 FOI Services, Inc.
2018-6568 08/14/2018 Walker, Joseph
2018-6569 08/14/2018 Forbes Media LLC

2018-657 01/25/2018 Auris Surgical Robotics, Inc.

2018-6572 08/14/2018 Regulatory Professionals Inc.
2018-6574 08/14/2018 ALDER LAW PC
2018-6575 08/14/2018 PREG ODONNELL GILLETT PLLC
2018-6576 08/14/2018 KNABE KRONING ET AL
2018-6577 08/14/2018 KNABE KRONING ET AL

2018-6578 08/14/2018 Doe J
Indiana University, Department of History and
2018-6579 08/14/2018 Philosophy of Science
2018-658 01/25/2018 FOI Services, Inc.
2018-6580 08/14/2018 BLOOMBERG
2018-6582 08/14/2018 PROMEDOSS INC
2018-6583 08/14/2018 LASKY LASER CENTER

2018-6584 08/14/2018 Peter Grosz
2018-6586 08/15/2018 INSIDE WASHINGTON PUBLISHERS

2018-6588 08/15/2018 Biomedical Research Institute of America
2018-659 01/25/2018 MEDTRONIC
2018-6591 08/15/2018 Pamela Williamson
2018-6592 08/15/2018 General Mills - FSQ
2018-6594 08/15/2018 FDAZILLA

2018-6595 08/15/2018 SHIRE

2018-6597 08/15/2018 OptiNose
2018-6599 08/15/2018 Irvin, Ellen M
2018-66 01/03/2018 B&H Consulting Services Inc.
2018-660 01/25/2018 Baird
2018-6600 08/15/2018 Eurofarma Laboratórios S.A.
2018-6601 08/15/2018 D Sanon
2018-6602 08/15/2018 FDAZILLA

2018-6604 08/15/2018 Haney & Young

2018-6606 08/15/2018 WEST PHARMACEUTICAL
2018-6608 08/15/2018 UNIVERSITY OF MARYLAND, BALTIMORE

2018-6609 08/15/2018 GENENTECH INC
2018-661 01/25/2018 FDAAWARE
2018-6610 08/15/2018 Registrar Corp
2018-6611 08/15/2018 PT. Ferron Par Pharmaceuticals

2018-6614 08/15/2018 PneumRx,Inc. a BTG International group company
2018-6616 08/15/2018 FDAZILLA

2018-6617 08/15/2018 Piper Access
2018-6618 08/15/2018 GUERBET LLC

2018-6619 08/15/2018 Epigenomics AG
2018-662 01/25/2018 AMGEN

2018-6623 08/15/2018 FOI Services, Inc.
2018-6624 08/15/2018 Law Offices of Sadaka Associates

2018-6625 08/16/2018 kimkhoe
2018-6626 08/16/2018 Vallon Pharmaceuticals, Inc.
2018-6627 08/16/2018 Waterstone Management Group
2018-6628 08/16/2018 Interchem Corp
2018-6629 08/16/2018 Dechra Ltd

2018-663 01/25/2018 ZUCKERMAN SPAEDER LLP
2018-6630 08/16/2018 Waterstone Management Group
2018-6631 08/16/2018 Lijun Ye
2018-6632 08/16/2018 FDAZILLA

2018-6633 08/16/2018 Beth Beyer
2018-6634 08/16/2018 Beth Beyer
2018-6636 08/16/2018 Murdock & Associates
2018-6637 08/16/2018 Target Health Inc.
2018-6638 08/16/2018 MarketWatch / Dow Jones

2018-6639 08/16/2018 Burke Medical Research Institute
2018-6640 08/16/2018 BLOOMBERG NEWS
2018-6642 08/16/2018 King, Michael
2018-6643 08/16/2018 Murdock & Associates
2018-6645 08/16/2018 GoMacro
2018-6646 08/16/2018 Ava AG
2018-6647 08/16/2018 Beth Beyer
2018-6648 08/16/2018 FDAAWARE
The Public Justice Advocacy Clinic at The George
2018-6649 08/16/2018 Washington University Law School
2018-665 01/25/2018 BECTON DICKINSON
2018-6650 08/16/2018 LONZA BIOLOGICS, INC
2018-6651 08/16/2018 MicroVention

2018-6653 08/16/2018 AFCEA Belvoir
2018-6654 08/16/2018 FOI Services, Inc.
2018-6655 08/16/2018 Vivalnk, Inc.
2018-6656 08/16/2018 SOTERA WIRELESS
2018-6658 08/16/2018 Scientific American magazine

2018-6659 08/16/2018 FOI Services, Inc.

2018-6660 08/16/2018 Truth Initiative
2018-6661 08/16/2018 Bettina Kaplan
2018-6662 08/16/2018 Maplehurst Bakeries, LLC
2018-6663 08/16/2018 Point Loma Strategic Research

2018-6664 08/16/2018 Vivalnk, Inc.
2018-6665 08/16/2018 Vivalnk, Inc.
2018-6667 08/16/2018 Vivalnk, Inc.
2018-6668 08/16/2018 MUCKROCK

International Consortium for Investigative
2018-6669 08/16/2018 Journalists
2018-667 01/25/2018 FOIA GROUP INC
2018-6670 08/16/2018 FOI Services, Inc.
2018-6671 08/16/2018 DAVID SCHUSTER
2018-6672 08/16/2018 FOI Services, Inc.

Nemours Foundation: Biomedical Research
2018-6674 08/16/2018 Department
2018-6675 08/16/2018 FDAZILLA
2018-6676 08/16/2018 Northgate Gonzalez, LLC

2018-6677 08/16/2018 Amanda Dykeman, ASHES Nonprofit
2018-668 01/25/2018 STAT
2018-6682 08/16/2018 John Smith
2018-6683 08/16/2018 Susan Schiffman, Professor NCSU
2018-669 01/25/2018 BANK OF AMERICA
2018-6690 08/16/2018 Gelson's Market
2018-6691 08/16/2018 Mark Miles research pharmacist

2018-6692 08/16/2018 Zimmer Biomet
2018-6693 08/16/2018 MASSACHUSETTS GENERAL HOSPITAL
2018-6694 08/16/2018 Rapp Medical Systems, Inc. representing Medtronic
2018-6695 08/16/2018 UNIVERSITY OF CALIFORNIA SAN FRANCISCO

2018-6696 08/16/2018 Wright Schimmel, LLC
2018-6697 08/17/2018 ARCHER NORRIS
2018-6699 08/17/2018 STANFORD UNIVERSITY SCHOOL OF MEDICINE

2018-67 01/03/2018 FOI Services, Inc.
2018-670 01/25/2018 Parks & Solar LLP

2018-6700 08/17/2018 Renner Capital Partners
2018-6701 08/17/2018 Target Health Inc.
2018-6702 08/17/2018 Moonbay Regulatory, LLC
2018-6703 08/17/2018 FOI Services, Inc.
2018-6705 08/17/2018 Ted Bei

2018-6706 08/17/2018 McCarter & English, LLP
Yale Collaboration for Research Integrity and
2018-6707 08/17/2018 Transparency
2018-6708 08/17/2018 STAT
2018-6709 08/17/2018 Symbiotic Research, LLC
2018-6710 08/17/2018 KNOWLEDGE ECOLOGY INTERNATIONAL
2018-6711 08/17/2018 Doe J
2018-6712 08/17/2018 Waters and Kraus, LLP
2018-6713 08/17/2018 Charite Medical School
2018-6714 08/17/2018 Taiho Oncology Inc.

2018-6715 08/17/2018 Doe J
2018-6716 08/17/2018 CANOPY MEDICAL INC
2018-6717 08/17/2018 FOI Services, Inc.
2018-6718 08/17/2018 FOI Services, Inc.
2018-6719 08/17/2018 FOI Services, Inc.
2018-672 01/25/2018 FDAZILLA

2018-6720 08/17/2018 FOI Services, Inc.
2018-6721 08/17/2018 ALSTON & BIRD
2018-6722 08/17/2018 FOI Services, Inc.
2018-6723 08/17/2018 FOI Services, Inc.
2018-6724 08/17/2018 FOI Services, Inc.
2018-6726 08/17/2018 WILEY REIN LLP
2018-6727 08/17/2018 FDA NEWS
2018-6728 08/17/2018 FDA NEWS
2018-6729 08/17/2018 Guilford College
2018-673 01/25/2018 LIFE EXTENSION
2018-6730 08/17/2018 Phalcon Investing LLC
2018-6731 08/17/2018 Indianapolis Business Journal
2018-6732 08/17/2018 THE PARROT POSSE

2018-6733 08/17/2018 Private Limited
2018-6735 08/17/2018 LinkBio

2018-6736 08/17/2018 Registrar Corp
2018-6737 08/17/2018 Galephar Pharmaceutical Inc.
2018-6738 08/17/2018 Reese Poyfair Richards, PLLC
2018-6739 08/17/2018 WALKUP MELODIA ET AL

2018-6740 08/17/2018 SWEDISH MATCH USA INC
2018-6741 08/17/2018 Eagle Pharmaceuticals Inc.


2018-6747 08/17/2018 HODES, SCOTT A
2018-6748 08/17/2018 NATIONAL TREASURY EMPLOYEES UNION

2018-675 01/25/2018 STAT
2018-6751 08/20/2018 FOIA GROUP INC
2018-6753 08/20/2018 STAT

2018-6754 08/20/2018 STAT
2018-6755 08/20/2018 STAT
2018-6756 08/20/2018 STAT
2018-6757 08/20/2018 FDA NEWS
2018-6758 08/20/2018 FDA NEWS
2018-6759 08/20/2018 FDAZILLA

2018-676 01/25/2018 Odom and DesRoches LLC
2018-6760 08/20/2018 FDAZILLA
2018-6761 08/20/2018 STAT
2018-6762 08/20/2018 FDA NEWS

2018-6763 08/20/2018 FDAZILLA
2018-6765 08/20/2018 FOI Services, Inc.
2018-6766 08/20/2018 LAVIGNE, CHANTAL
2018-6767 08/20/2018 Allergan, Inc
2018-6768 08/20/2018 Reinhart Boerner Van Deuren

2018-6769 08/20/2018 Searcy Denney Scarola Barnhart & Shipley, PA
2018-677 01/25/2018 FOI Services, Inc.

2018-6771 08/20/2018 PharmReg Consulting
2018-6772 08/20/2018 PHOTOCURE ASA
2018-6773 08/20/2018 Tops Markets, LLC

2018-6774 08/20/2018 Neuvosyn Laboratories, LLC
2018-6775 08/20/2018 KING & SPALDING
2018-6776 08/20/2018 FDA NEWS
2018-6777 08/20/2018 FDA NEWS

2018-6778 08/20/2018 FDA NEWS
2018-6779 08/20/2018 FDA NEWS

2018-6780 08/20/2018 FDA NEWS
2018-6781 08/20/2018 FDA NEWS
2018-6782 08/20/2018 FDA NEWS
2018-6783 08/20/2018 FDA NEWS
2018-6784 08/20/2018 FDA NEWS

2018-6785 08/20/2018 FDA NEWS
2018-6786 08/20/2018 Nation Analytics
2018-6787 08/20/2018 FDA NEWS
2018-6788 08/20/2018 Nation Analytics
2018-6789 08/20/2018 FDA NEWS

2018-679 01/25/2018 General Hospital AZ Nikolaas
2018-6790 08/20/2018 Medtrade Products Ltd
2018-6791 08/20/2018 FDAZILLA
2018-6793 08/20/2018 FDA NEWS
2018-6794 08/20/2018 FDA NEWS
2018-6795 08/20/2018 FDA NEWS
2018-6796 08/20/2018 FDA NEWS
2018-6797 08/20/2018 FDA NEWS

2018-6798 08/20/2018 Orchid Orthopedic Solutions
2018-6799 08/20/2018 FDA NEWS

2018-68 01/03/2018 FOI Services, Inc.
2018-680 01/25/2018 FDAZILLA

2018-6801 08/20/2018 FDA NEWS
2018-6802 08/20/2018 Richardson Patrick Westbrook & Brickman, LLC
2018-6803 08/20/2018 Carol Sassa

2018-6804 08/20/2018 ElastiMed
2018-6805 08/20/2018 BioSecure Risk Management

2018-6806 08/20/2018 Mark Gold
2018-6807 08/21/2018 FDAZILLA

2018-6808 08/21/2018 The New York Times Magazine
2018-6809 08/21/2018 Dr. Reddy's Laboratories Inc.,

2018-6811 08/21/2018 FDAZILLA

2018-6812 08/21/2018 Precision Laser Specialist
2018-6813 08/21/2018 US WorldMeds, LLC

2018-6815 08/21/2018 Ted Bei
2018-6816 08/21/2018 Fryer, Shuster, Lester & Pollack, P.C.
2018-6817 08/21/2018 Philips
2018-682 01/25/2018 FDAZILLA
2018-6820 08/21/2018 RRCM

2018-6821 08/21/2018 Whatley Kallas LLP
2018-6822 08/21/2018 none
2018-6823 08/21/2018 none
2018-6824 08/21/2018 Aspen Insurance
2018-6825 08/21/2018 Aspen Insurance
2018-6826 08/21/2018 FDAZILLA

2018-6827 08/21/2018 thomas pauly
Harris Orthopaedic Laboratory - Massachusetts
2018-6828 08/21/2018 General Hospital
2018-6829 08/21/2018 GLW, Inc

2018-6830 08/21/2018 D Sanon
2018-6831 08/21/2018 KEYS 22458-017, CLAY
2018-6832 08/21/2018 the Wood Burditt group

2018-6834 08/21/2018 Salamandra, LLC

2018-6835 08/21/2018 Doe J
2018-6836 08/21/2018 RAY THOMPSON
2018-6837 08/21/2018 RAY THOMPSON
2018-6838 08/21/2018 RAY THOMPSON
2018-6839 08/21/2018 Apteka Corp
2018-6840 08/21/2018 SPF North America, Inc.

2018-6841 08/21/2018 MEDTRONIC
2018-6842 08/21/2018 FDAZILLA

2018-6843 08/21/2018 Andrea Woodruff
University of Texas at Tyler Fisch College of
2018-6846 08/21/2018 Pharmacy
2018-6848 08/21/2018 TRACEY & FOX
2018-685 01/25/2018 FDAZILLA

2018-6852 08/21/2018 ITG BRANDS

2018-6853 08/22/2018 Bloomberg Law

2018-6855 08/22/2018 bloomtre partners
2018-6856 08/22/2018 mashal, ian

2018-6858 08/22/2018 Jason Merkel

2018-6859 08/22/2018 Grifols Biomat USA, Inc.
2018-6862 08/22/2018 PUBLIC CITIZEN
2018-6863 08/22/2018 NTK Network

2018-6864 08/22/2018 ConMed Corporation

2018-687 01/25/2018 FDAZILLA

2018-6871 08/22/2018 Walker, Joseph
Arrow International, Inc. (subsidiary of
2018-6872 08/22/2018 Teleflex, Incorporated)
Arrow International, Inc (subsidiary of Teleflex,
2018-6873 08/22/2018 Incorporated)
Arrow International, Inc. (subsidiary of Teleflex
2018-6874 08/22/2018 Incorporated)
2018-6875 08/22/2018 Eywa Pharma Inc.
Arrow International, Inc. ( subsidiary of
2018-6876 08/22/2018 Teleflex, Incorporated)
2018-6877 08/22/2018 Leeder Law
2018-6879 08/22/2018 LUMINA HEALTH PRODUCTS INC

2018-6880 08/22/2018 Doe J
2018-6881 08/22/2018 TRAN, NATALIE

2018-6882 08/23/2018 Eywa Pharma Inc.
2018-6883 08/23/2018 Aerogen Pharma Corp
2018-6884 08/23/2018 DLA Piper LLP (US)
2018-6885 08/23/2018 DLA Piper LLP (US)
2018-6886 08/23/2018 DLA Piper LLP (US)
2018-6887 08/23/2018 DLA Piper LLP (US)
2018-6888 08/23/2018 DLA Piper LLP (US)
2018-6889 08/23/2018 DLA Piper LLP (US)

2018-6890 08/23/2018 Hastings Law Firm PC
2018-6891 08/23/2018 STEPTOE & JOHNSON
2018-6892 08/23/2018 Newsy
2018-6893 08/23/2018 Aerogen Pharma Corp
2018-6894 08/23/2018 PIPER JAFFRAY & CO
2018-6895 08/23/2018 SurModics, Inc.
2018-6896 08/23/2018 Celeste Parks
2018-6897 08/23/2018 INSTITUTE FOR JUSTICE

2018-6898 08/23/2018 AMRI SSCI, LLC
2018-6899 08/23/2018 STRYKER ENDOSCOPY

2018-69 01/03/2018 Mark Schafer
2018-6900 08/23/2018 Newsy
2018-6901 08/23/2018 Grifols Therapeutics, Inc
2018-6902 08/23/2018 Hirabara Engineering Service Ltd.
2018-6903 08/23/2018 Oppenheimer & Co.
2018-6904 08/23/2018 Newsy

2018-6905 08/23/2018 DLA Piper LLP (US)
2018-6906 08/23/2018 Will Ryan
2018-6908 08/23/2018 Krystal Horchuck
2018-6909 08/23/2018 Taejoon Pharmaceutical Co., Ltd.
2018-691 01/25/2018 FDAZILLA

2018-6912 08/24/2018 Jennifer O'Sullivan
2018-6913 08/24/2018 MedReleaf Corporation
2018-6917 08/24/2018 Anthony Roberts
2018-6918 08/24/2018 Randy Byrd, LLC

2018-6919 08/24/2018 B Zada
2018-692 01/25/2018 FDAZILLA
2018-6920 08/24/2018 Lynne Peeples Freelance/Environmental Health News

2018-6921 08/24/2018 EZPrint Supplies
2018-6922 08/24/2018 Whatley Kallas LLP

2018-6923 08/24/2018 Glaukos Corporation
2018-6924 08/24/2018 Glaukos Corporation
2018-6926 08/24/2018 Mankind Pharma Ltd.
2018-6927 08/24/2018 American Surgical Company LLC
2018-6928 08/24/2018 Mankind Pharma Ltd.

2018-693 01/25/2018 JENSEN & ASSOCIATES PLLC

2018-6933 08/24/2018 FDAAWARE
2018-6934 08/24/2018 GenPrime, Inc.
2018-6935 08/24/2018 US Biotest, Inc.
2018-6936 08/24/2018 Verena von Dehn

2018-6937 08/24/2018 FOI Services, Inc.
2018-6938 08/24/2018 MONUMENTAL PROCESS SERVERS
2018-694 01/25/2018 WALL STREET JOURNAL
2018-6940 08/24/2018 LifeSouth Community Blood Centers, Inc.
2018-6941 08/24/2018 DINSMORE & SHOHL LLP

2018-6945 08/24/2018 PANISH SHEA & BOYLE LLP

2018-6946 08/24/2018 LEATHERWOOD #0236240, JON
2018-6947 08/24/2018 Torreya Partners

2018-6948 08/24/2018 FRESCA MEDICAL
2018-6949 08/27/2018 John W Davis

2018-695 01/25/2018 MARINA BIOTECH

2018-6952 08/27/2018 FOI Services, Inc.
2018-6953 08/27/2018 FOI Services, Inc.
2018-6954 08/27/2018 FOI Services, Inc.
2018-6955 08/27/2018 FOI Services, Inc.
2018-6956 08/27/2018 BioMarin Pharmaceutical Inc.

2018-6957 08/27/2018 Neuberger and Associates LLC

2018-696 01/25/2018 MUCKROCK NEWS
2018-6960 08/27/2018 Kinamed, Inc.
2018-6961 08/27/2018 Sundar Srinivasan
2018-6962 08/27/2018 Yancey's Fancy, Inc

2018-6963 08/27/2018 Brandon Fremd

2018-6965 08/28/2018 thomas pauly
2018-6966 08/28/2018 Cipla Limited
2018-6967 08/28/2018 FOI Services, Inc.
2018-6968 08/28/2018 BERNSTEIN RESEARCH

2018-6969 08/28/2018 JOURNALISTS
2018-697 01/25/2018 BLANK ROME LLP

2018-6971 08/28/2018 Christina Chow
PROFESSIONAL COMPOUNDING CENTERS OF AMERICA
2018-6972 08/28/2018 (PCAA)
2018-6973 08/28/2018 Wright Foods
2018-6974 08/28/2018 FOI Services, Inc.
2018-6975 08/28/2018 Perry, Rachel
2018-6976 08/28/2018 Boston Scientific, Inc.

2018-6978 08/28/2018 PALL CORPORATION
2018-6979 08/28/2018 MCGREGOR, TERRI
2018-698 01/25/2018 BLANK ROME LLP
2018-6980 08/28/2018 Dysart Law Firm, PC
2018-6981 08/28/2018 Rachel Perry
2018-6985 08/28/2018 PETA
2018-6986 08/28/2018 WASHINGTON POST
2018-6987 08/28/2018 FOX NEWS
2018-6988 08/28/2018 CONWAY HOMER PC
2018-6989 08/28/2018 CONWAY HOMER PC

2018-699 01/25/2018 MUCKROCK NEWS

2018-6991 08/28/2018 FDAZILLA
2018-6993 08/29/2018 Mallory Ulmer
2018-6995 08/29/2018 Andrea Woodruff
2018-6996 08/29/2018 INTERNATIONAL DAIRY FOODS ASSOCIATION

2018-6997 08/29/2018 RBC
2018-6998 08/29/2018 Hyman, Phelps & McNamara, P.C. (Karla L. Palmer)

2018-6999 08/29/2018 D Sanon
2018-7 01/02/2018 ALK-Abello, Inc.
2018-700 01/25/2018 DEUTSCH KERRIGAN & STILES
2018-7000 08/29/2018 Murray Carpenter

2018-7001 08/29/2018 Alnylam Pharmaceuticals

2018-7003 08/29/2018 KOLEY JESSEN ATTYS
2018-7004 08/29/2018 KEYS 22458-017, CLAY

2018-7005 08/29/2018 KEYS 22458-017, CLAY
2018-7006 08/29/2018 M4D LLC
2018-7007 08/29/2018 LAW OFFICE OF JANET LINDNER SPIELBERG
2018-7008 08/29/2018 HUMPHREY, MIKE
2018-7009 08/29/2018 FONTAINE 148904, ANDY
2018-701 01/25/2018 UNILAB
2018-7010 08/29/2018 PRITZKER HAGERMAN PA
2018-7011 08/29/2018 Mitra Law Group
2018-7012 08/29/2018 WILSON ELSER ET AL

2018-7014 08/30/2018 ICS Georgia, Inc. dba Pyrazine Specialties, Inc.

2018-7016 08/30/2018 American Vaping Association

2018-7018 08/30/2018 FOOD SAFETY NEWS

2018-7020 08/30/2018 Potrero Medical
2018-7021 08/30/2018 Scott Richardson

2018-7022 08/30/2018 MUCKROCK
2018-7023 08/30/2018 SANTIAGO, WENDY
2018-7024 08/30/2018 HILL DERMACEUTICALS INC
2018-7025 08/30/2018 Penn Law LLC

2018-7026 08/30/2018 MiMedx Group, Inc.
2018-7027 08/31/2018 none
2018-7028 09/04/2018 Registrar Corp
2018-7029 09/04/2018 STAT
2018-703 01/25/2018 PETERSON & ASSOC PC

2018-7030 09/04/2018 FDAZILLA
2018-7031 09/04/2018 FOI Services, Inc.
2018-7032 09/04/2018 Lieff Cabraser Heimann & Bernstein LLP

U.S. Public Interest Research Group Education
2018-7034 09/04/2018 Fund, Inc.
2018-7035 09/04/2018 FOI Services, Inc.

2018-7037 09/04/2018 RA MEDICAL SYSTEMS INC.
2018-7039 09/04/2018 (DICE)
2018-7040 09/04/2018 MAC Medical

2018-7041 09/04/2018 Arent Fox, LLP
2018-7042 09/04/2018 FDAZILLA

2018-7044 09/04/2018 Ceva Animal Health
2018-7046 09/04/2018 The Shaivite Temple

2018-7047 09/04/2018 Newsy
2018-7048 09/04/2018 KELLEY DRYE & WARREN

2018-7052 09/04/2018 FOI Services, Inc.
2018-7053 09/04/2018 FOI Services, Inc.
2018-7054 09/04/2018 FOI Services, Inc.
2018-7055 09/04/2018 HARE WYNN NEWELL & NEWTON LLP
2018-7056 09/04/2018 PharmaForce Inc.
2018-7057 09/04/2018 FOI Services, Inc.

2018-7058 09/04/2018 Posey Lebowitz PLLC
2018-7059 09/04/2018 SANOFI PASTEUR
2018-7061 09/04/2018 ICIJ
2018-7063 09/04/2018 Daily Caller News Foundation

2018-7064 09/04/2018 ET Now
2018-7065 09/04/2018 FOI Services, Inc.
2018-7066 09/04/2018 PharmaLogic Development, Inc.
2018-7067 09/04/2018 Journalists
2018-7068 09/04/2018 Newsy
2018-7069 09/04/2018 FDAZILLA
2018-707 01/26/2018 Accord Media - Michael Chibbaro
2018-7072 09/05/2018 Kleinfeld, Kaplan, Becker
2018-7073 09/05/2018 Seafood Products Association

2018-7074 09/05/2018 Global Protection Corp.

2018-7077 09/05/2018 Precision Laser Specialist, Inc.
2018-7078 09/05/2018 Tonya B Porter
2018-7079 09/05/2018 Tonya Porter

2018-708 01/26/2018 DEUTSCHE BANK
2018-7080 09/05/2018 Bioness Inc.
2018-7081 09/05/2018 David Horn
2018-7082 09/05/2018 Provisions International
2018-7083 09/05/2018 Martorell Law APC

2018-7084 09/05/2018 Rajvi Agravat
2018-709 01/26/2018 Morgan Stanley
2018-7091 09/05/2018 Alliance Bernstein
2018-7092 09/05/2018 Vivotronix
2018-7093 09/05/2018 ICIJ

2018-7094 09/05/2018 barbara kurys
2018-7095 09/05/2018 FOOD SAFETY NEWS

2018-7096 09/05/2018 BloombergQuint
2018-7098 09/05/2018 Equirus Capital
2018-7099 09/05/2018 Newsy

2018-7100 09/05/2018 Dr Ajay Phadke
2018-7102 09/05/2018 ET Now
2018-7103 09/05/2018 PHARM3R
2018-7104 09/05/2018 Reveal + The Center for Investigative Reporting

2018-7105 09/05/2018 Doe J
2018-7107 09/05/2018 BASF SE
2018-7108 09/05/2018 KELLER ROHRBACK LLP
2018-711 01/26/2018 AMGEN INC.

2018-7111 09/05/2018 ANDREW, GARRET
2018-7112 09/05/2018 SAMSTER KONKEL ET AL
2018-7113 09/05/2018 LEWIS BRISBOIS ET AL

2018-7114 09/05/2018 LEWIS BRISBOIS ET AL
2018-7115 09/06/2018 MarketWatch / Dow Jones

2018-7116 09/06/2018 MEDTRONIC
2018-7119 09/06/2018 Michael Zhadkevich
2018-712 01/26/2018 ET Now
2018-7120 09/06/2018 B Zada
2018-7121 09/06/2018 Beth Beyer
2018-7122 09/06/2018 The Law Office of Benjamin Korn, PLLC
2018-7123 09/06/2018 Alicia Antiri

2018-7125 09/06/2018 Garleb Brothers Consulting, LLC
2018-7126 09/06/2018 Registrar Corp
2018-7127 09/06/2018 Registrar Corp
2018-7128 09/06/2018 UNIVERSITY OF MINNESOTA
2018-7129 09/06/2018 CSL Plasma, Inc.

2018-7130 09/06/2018 Indivior Inc.
2018-7131 09/07/2018 Lomurro Law
2018-7132 09/07/2018 lomurro loaw
2018-7133 09/07/2018 Lomurro Law
2018-7134 09/07/2018 FDAZILLA

2018-7136 09/07/2018 FDAAWARE
2018-7137 09/07/2018 FDAAWARE

2018-7139 09/07/2018 Doe J
2018-714 01/26/2018 Institute of Pharmacy, Nirma University
2018-7141 09/07/2018 Sage Alliance Consulting Inc.

2018-7142 09/07/2018 FDAZILLA
2018-7148 09/07/2018 ZOLL Medical- Elizabeth McMeniman
2018-7149 09/07/2018 HemoCue AB
2018-7152 09/07/2018 Interchem Corp
2018-7153 09/07/2018 MAQUET Cardiovascular, LLC
2018-7154 09/07/2018 MEDTRONIC

2018-7155 09/07/2018 D Sanon
2018-7156 09/07/2018 Venebio Group, LLC
2018-7157 09/07/2018 United Exchange Corp.
2018-7158 09/07/2018 Zydus Pharmaceuticals (USA) Inc.

2018-7159 09/07/2018 Dr Ajay Phadke
2018-716 01/26/2018 KASHIV PHARMA,LLC
2018-7160 09/07/2018 FDA NEWS
2018-7161 09/07/2018 United Exchange Corp.
University of California - San Francisco, Dept.

2018-7162 09/07/2018 of Medicine, Division of Hematology/Oncology
2018-7163 09/07/2018 Odom & Des Roches, LLC
2018-7164 09/07/2018 AMERICAN RED CROSS
2018-7165 09/07/2018 J.P. Morgan India Pvt Ltd
2018-7166 09/07/2018 Erica W. Stump, P.A.
2018-7168 09/07/2018 Business Television India (BTVI)
2018-7169 09/07/2018 FOI Services, Inc.
2018-7170 09/07/2018 Doe J
2018-7171 09/07/2018 LINCARE INC
2018-7173 09/07/2018 ALLIANCE FOR NATURAL HEALTH USA
2018-7174 09/07/2018 ALLIANCE FOR NATURAL HEALTH USA
2018-7175 09/07/2018 BENAVENTE, MARIA
2018-7176 09/07/2018 Doe J


2018-7180 09/10/2018 LinkBio Corp
2018-7181 09/10/2018 Zhadkevich, Michael
2018-7182 09/10/2018 West Duluth Distribution DBA CHK Nutrition
2018-7183 09/10/2018 SWARTZ CAMPBELL LLC

2018-7184 09/10/2018 EUROIMMUN US, Inc.
2018-7185 09/10/2018 jaime lester
2018-7186 09/10/2018 Shenzhen Comen Medical Instruments Co., Ltd.
2018-7187 09/10/2018 Alliance Bernstein
2018-7188 09/10/2018 Thomas Sobotka, Ph.D.

2018-7189 09/10/2018 CASE WESTERN RESERVE UNIVERSITY

2018-7190 09/10/2018 Osler, Hoskin & Harcourt LLP
2018-7192 09/10/2018 Michael Tobin
2018-7193 09/10/2018 Robyn Harrington

2018-7195 09/10/2018 Registrar Corp

2018-7197 09/10/2018 SHIRE
2018-7198 09/10/2018 Brittany Eickstead
2018-7199 09/10/2018 vonBriesen & Roper, S.C.
2018-7200 09/10/2018 Rachel Perry
2018-7201 09/10/2018 FDAZILLA

2018-7202 09/10/2018 Eton Pharmaceuticals, Inc

2018-7204 09/10/2018 UNIVERSITY OF MARYLAND, BALTIMORE
2018-7205 09/10/2018 PSI International, Inc.
2018-7206 09/10/2018 FDAZILLA
2018-7207 09/10/2018 FRASER STRYKER PC LLO

2018-7208 09/10/2018 FDAZILLA
2018-7209 09/10/2018 AMGEN
2018-721 01/26/2018 Newsy
2018-7210 09/10/2018 FDAZILLA


2018-7216 09/10/2018 ELITech Group

2018-7217 09/10/2018 KONIGSTEIN, DAVID

2018-7223 09/10/2018 LANAN, KIMBERLY ANN

2018-7226 09/10/2018 FDA NEWS
2018-7227 09/10/2018 FOI Services, Inc.

2018-7232 09/10/2018 FDA NEWS
2018-7233 09/10/2018 FOI Services, Inc.
2018-7238 09/10/2018 FOI Services, Inc.
2018-7242 09/10/2018 FOI Services, Inc.
2018-7245 09/11/2018 LUITPOLD PHARMACEUTICALS INC
2018-7246 09/11/2018 Dr. Michael Zhadkevich
2018-7247 09/11/2018 Gnosiis International, LLC

2018-7248 09/11/2018 Registrar Corp
2018-7249 09/11/2018 Technology Crossover Ventures

2018-725 01/26/2018 Teleflex Incorporated
2018-7251 09/11/2018 FDAZILLA
2018-7252 09/11/2018 FDAZILLA

2018-7254 09/11/2018 Biomedical Research Institute of America

2018-7256 09/11/2018 FourWorld Capital Management
2018-7257 09/11/2018 Morgan & Morgan, P.A.
2018-7258 09/11/2018 Denio Lourenco
2018-7259 09/11/2018 FOI Services, Inc.
2018-7260 09/11/2018 Deborah Carter
2018-7261 09/11/2018 FDAZILLA
2018-7262 09/11/2018 FDAZILLA
2018-7263 09/11/2018 FDAZILLA
2018-7264 09/11/2018 FDAZILLA
2018-7265 09/11/2018 FDAZILLA
2018-7266 09/11/2018 FDAZILLA
2018-7267 09/11/2018 Journal of Physical Security

2018-7270 09/11/2018 Indivior Inc.

2018-7271 09/11/2018 JP MORGAN
2018-7272 09/11/2018 FDAZILLA

2018-7273 09/11/2018 FDAZILLA
2018-7274 09/11/2018 Axis Capital Limited
2018-7275 09/11/2018 NDA Partners
2018-7276 09/11/2018 FOIA GROUP INC
2018-7277 09/11/2018 FOIA GROUP INC
2018-7278 09/11/2018 FOI Services, Inc.

2018-7279 09/11/2018 FDA NEWS
2018-728 01/26/2018 Micro Therapeutic Research Labs Pvt.Ltd

2018-7280 09/12/2018 Trust International Group LLC
2018-7281 09/12/2018 TekTeam LLC.
2018-7282 09/12/2018 FDAZILLA
2018-7283 09/12/2018 HealthCare Royalty Partners

2018-7284 09/12/2018 PERRIGO COMPANY
2018-7288 09/12/2018 FOI Services, Inc.
2018-7289 09/12/2018 FOI Services, Inc.

2018-7290 09/12/2018 PERRIGO COMPANY
2018-7291 09/12/2018 Beckman Coulter, Inc.
2018-7292 09/12/2018 Cynthia Novella
2018-7293 09/12/2018 FOI Services, Inc.
2018-7294 09/12/2018 Mark Miles reeaserch pharmacist

2018-7295 09/12/2018 NeuroRex
2018-7296 09/12/2018 NeuroRex
2018-7298 09/12/2018 Gabriella Fay
2018-7299 09/12/2018 Zoetis Inc.

2018-730 01/26/2018 Daniel Bernier
2018-7300 09/12/2018 FDAZILLA
2018-7301 09/12/2018 Newsy

2018-7303 09/12/2018 ICIJ
2018-7304 09/12/2018 ARENT FOX LLP
2018-7306 09/12/2018 INSTITUTE FOR PURE & APPLIED KNOWLEDGE

2018-7307 09/12/2018 CHAPPIDI, REKHA


2018-7310 09/12/2018 MY VACCINE LAWYER
2018-7311 09/12/2018 MY VACCINE LAWYER
2018-7312 09/12/2018 NEEDLE SPECIALTY PRODUCTS CORP
2018-7313 09/12/2018 ALSTON & BIRD LLP

2018-7314 09/12/2018 POMERANTZ LLP
2018-7315 09/12/2018 SAEN
2018-7316 09/12/2018 CITIZENS COMMISSION ON HUMAN RIGHTS INTERNATIONAL

2018-7318 09/13/2018 Doe J
2018-7320 09/13/2018 Doe J
2018-7323 09/13/2018 Newsy
2018-7324 09/13/2018 MUCKROCK

2018-7326 09/13/2018 Buzzfeed News

2018-7329 09/13/2018 Southwest Bio-Labs, Inc.
2018-7330 09/13/2018 pradeep dondapati

2018-7332 09/13/2018 FOI Services, Inc.

2018-7333 09/13/2018 Newsy
2018-7335 09/13/2018 Raymond James
2018-7336 09/13/2018 GoransonBain PLLC

University of Miami, Sylvester Comprehensive
2018-7339 09/13/2018 Cancer Center
2018-734 01/26/2018 Dr Ajay Phadke
2018-7340 09/13/2018 Raymond James
2018-7341 09/13/2018 Sunground Risk Control Robot(SGRCR)
2018-7342 09/13/2018 COOK ANIMAL HEALTH
2018-7343 09/13/2018 Beth Beyer
2018-7344 09/13/2018 Beth Beyer

2018-7345 09/13/2018 bioMerieux Inc.
2018-7347 09/13/2018 BIOLOGICS CONSULTING GROUP
2018-7348 09/13/2018 BURDOCK GROUP

2018-7349 09/13/2018 DCM
2018-735 01/26/2018 Morgan Stanley
2018-7350 09/13/2018 Par Pharmaceuticals Inc.
2018-7351 09/13/2018 Evonik Corporation
2018-7352 09/13/2018 FOI Services, Inc.

2018-7353 09/13/2018 HADLEY, KEITH
2018-7354 09/13/2018 DR REDDYS LABORATORIES INC
2018-7355 09/13/2018 REID M01684, R
2018-7356 09/13/2018 WALTERS LAW FIRM LLC
2018-7358 09/13/2018 ASHCRAFT & GEREL LLP

2018-7359 09/13/2018 Doe J

2018-7360 09/13/2018 BRIGHAM & WOMEN'S HOSPITAL, BLOOD BANK
2018-7363 09/13/2018 ST JUDE MEDICAL
2018-7364 09/14/2018 FOI Services, Inc.

2018-7365 09/14/2018 Zimmer Biomet
2018-7366 09/14/2018 Schiff & Company, Inc.

2018-7367 09/14/2018 Alicia Wight
2018-7372 09/14/2018 FOOD SAFETY NEWS
2018-7373 09/14/2018 FOI Services, Inc.
2018-7374 09/14/2018 FDAZILLA

2018-7375 09/14/2018 Viveve, Inc.
2018-7376 09/14/2018 Finkelstein, Andrew G
2018-7377 09/14/2018 FOOD SAFETY NEWS
2018-7378 09/14/2018 TWi Pharmaceuticals, Inc.
2018-7379 09/14/2018 Tonya Porter
2018-738 01/26/2018 Morgan Stanley

2018-7380 09/14/2018 FOIA GROUP INC
2018-7381 09/14/2018 FOOD SAFETY NEWS
2018-7382 09/14/2018 FOIA GROUP INC
2018-7383 09/14/2018 FOOD SAFETY NEWS

2018-7384 09/14/2018 Tonya Porter
2018-7385 09/14/2018 SMITHS MEDICAL ASD INC

2018-7386 09/14/2018 StimAire
2018-7388 09/14/2018 FOOD SAFETY NEWS

2018-7390 09/14/2018 BIOLOGICS CONSULTING GROUP
2018-7392 09/14/2018 FOI Services, Inc.
2018-7393 09/14/2018 FOI Services, Inc.

2018-7395 09/14/2018 Grant DuBois
2018-7397 09/17/2018 ICIJ
2018-7400 09/17/2018 AKIN GUMP STRAUSS HAUER & FELD LLP

2018-7401 09/17/2018 Dawn Firsingparis
2018-7403 09/17/2018 Thompson Coburn LLP, Ms. Eileen E. Boyle Perich

2018-7405 09/17/2018 FOI Services, Inc.

2018-7406 09/17/2018 VERNON & DURAY LLP
Kellogg School of Management, Northwestern
2018-7407 09/17/2018 University
2018-7409 09/17/2018 jonathan sackner-bernstein

2018-7411 09/17/2018 Registrar Corp
2018-7412 09/17/2018 Registrar Corp
2018-7413 09/17/2018 COLSON HICKS EIDSON LAW FIRM
2018-7414 09/17/2018 Review of Ophthalmology
2018-7415 09/17/2018 KTVT-TV
2018-7416 09/17/2018 Registrar Corp

2018-7418 09/17/2018 Joshua Insel
2018-7419 09/17/2018 Zachary En'Wezoh
2018-7420 09/17/2018 CTI Clinical Trial & Consulting Services
2018-7421 09/17/2018 Hedgeye Risk Management LLC
2018-7422 09/17/2018 Nicky Park

2018-7423 09/17/2018 Dan Malcic
2018-7424 09/17/2018 Registrar Corp
2018-7425 09/17/2018 SWARTZ CAMPBELL LLC

2018-7429 09/17/2018 FDAZILLA

2018-743 01/26/2018 Todd Mowl
2018-7431 09/17/2018 Searcy Denney Scarola Barnhart & Shipley, PA

2018-7432 09/17/2018 ICIJ
2018-7433 09/17/2018 Firefly Medical, Inc.

2018-7434 09/17/2018 KC LAW
2018-7438 09/17/2018 GAGE DEVELOPMENT COMPANY LLC

2018-7439 09/17/2018 BIOSCIENCESCORP LLC
2018-744 01/26/2018 FOI Services, Inc.
2018-7440 09/17/2018 ZUSMER, JOANNE

2018-7444 09/18/2018 MUCKROCK
2018-7445 09/18/2018 REED SMITH LLP
2018-7446 09/18/2018 WebMD

2018-7447 09/18/2018 ZetaGen Therapeutics

2018-7449 09/18/2018 FOI Services, Inc.
2018-745 01/29/2018 MYOLYN, LLC
2018-7451 09/18/2018 Wrght Schimmel LLC
2018-7452 09/18/2018 FDAAWARE

2018-7453 09/18/2018 Mark Connolly
2018-7454 09/18/2018 inverse.com

2018-7455 09/18/2018 FOI Services, Inc.
2018-7456 09/18/2018 FOI Services, Inc.
2018-7457 09/18/2018 AzkoNobel Specialty Chemicals

2018-7460 09/18/2018 MPM ADVISORS
2018-7461 09/18/2018 FOOD SAFETY NEWS

2018-7463 09/18/2018 US WorldMeds, LLC

2018-7465 09/18/2018 FDAZILLA
2018-7466 09/18/2018 Hoogland Spine Products GmbH
2018-7467 09/18/2018 FOI Services, Inc.

2018-747 01/29/2018 NICHOLAS & TOMASEVIC LLP

2018-7471 09/18/2018 FOI Services, Inc.

2018-7472 09/18/2018 ET Now
2018-7473 09/18/2018 Taiho Pharmaceutical Co., LTD.
2018-7474 09/18/2018 HARVARD LAW SCHOOL
2018-7475 09/18/2018 FOIA GROUP INC
2018-7476 09/18/2018 Prouty, Jonathon M

2018-7479 09/18/2018 FOI Services, Inc.
2018-748 01/29/2018 MILLER WEISBROD LLP
2018-7481 09/18/2018 Merck Animal Health

2018-7482 09/18/2018 Jerome Farmer
2018-7483 09/18/2018 FDAZILLA

2018-7485 09/18/2018 Dr Ajay Phadke
2018-7486 09/18/2018 ET Now

2018-7487 09/18/2018 GEORGE, BENJAMIN
2018-7489 09/18/2018 LACOVIA AND COMPANY LLC
2018-749 01/29/2018 Court Express
2018-7490 09/18/2018 REUTERS
2018-7491 09/18/2018 UNIV OF TEXAS AT TYLER FISCH COLLEGE OF PHARMACY

2018-7493 09/18/2018 WHITE OAK GROUP LLC

2018-7494 09/18/2018 FLAMINGO PHARMACEUTICALS LTD
2018-7495 09/18/2018 UNIV OF TEXAS AT TYLER FISCH COLLEGE OF PHARMACY

2018-7496 09/18/2018 Eywa Pharma Inc.
2018-7498 09/18/2018 FOI Services, Inc.
2018-750 01/29/2018 WAND-TV

2018-7502 09/18/2018 FOI Services, Inc.
2018-7506 09/18/2018 FDA NEWS
2018-7507 09/18/2018 D Sanon
2018-7508 09/18/2018 FOI Services, Inc.
2018-7509 09/18/2018 FOI Services, Inc.
2018-751 01/29/2018 MILLER WEISBROD LLP
2018-7514 09/18/2018 FDA NEWS
2018-7515 09/18/2018 FOI Services, Inc.

2018-7520 09/19/2018 Corey Nislow
2018-7521 09/19/2018 FOI Services, Inc.
2018-7523 09/19/2018 Ken Emmer
2018-7524 09/19/2018 Michiko Miyashita

2018-7525 09/19/2018 Axar Pharmaceuticals Inc
2018-7527 09/19/2018 Christopher Young
2018-7528 09/19/2018 Actial Farmaceutica
2018-7529 09/19/2018 FOI Services, Inc.
2018-753 01/29/2018 Tracey Helgeson

2018-7530 09/19/2018 OsteoReady LLC
2018-7531 09/19/2018 Premier Biotech, Inc.
2018-7532 09/19/2018 Abbott Molecular Inc.
2018-7533 09/19/2018 AirStrip Technology Inc.
2018-7535 09/19/2018 FOI Services, Inc.

2018-7538 09/19/2018 FOI Services, Inc.
2018-7539 09/19/2018 FOI Services, Inc.

2018-754 01/29/2018 Sanofi Genzyme
2018-7540 09/19/2018 FOI Services, Inc.
2018-7541 09/19/2018 FOI Services, Inc.

2018-7542 09/19/2018 Combe Inc.

2018-7544 09/19/2018 Jamee Cook
2018-7545 09/19/2018 Takeda Pharmaceutical Company Limited

2018-7546 09/19/2018 FOI Services, Inc.
2018-7547 09/19/2018 McDermott Will & Emery LLP
2018-7548 09/19/2018 FOI Services, Inc.

2018-7549 09/19/2018 Vikas Khurana
2018-7550 09/20/2018 BLOOMBERG NEWS
2018-7551 09/20/2018 FOI Services, Inc.

2018-7552 09/20/2018 BLOOMBERG NEWS
2018-7553 09/20/2018 Axis Capital Limited
2018-7555 09/20/2018 Kashiv pharma LLC
2018-7556 09/20/2018 Northwestern Medicine Lake Forest Hospital

2018-7557 09/20/2018 BloombergQuint
2018-7558 09/20/2018 RAY THOMPSON
2018-7559 09/20/2018 FDAZILLA
2018-756 01/29/2018 MUCKROCK NEWS
HSBC Securities and Capital Markets (India) Pvt
2018-7560 09/20/2018 Ltd
2018-7561 09/20/2018 FOI Services, Inc.

2018-7562 09/20/2018 Cuneo Gilbert & LaDuca LLP
2018-7563 09/20/2018 FOI Services, Inc.
2018-7565 09/20/2018 OREXO AB
2018-7566 09/20/2018 Morgan Stanley
2018-7567 09/20/2018 Leahy & Hoste
2018-7568 09/20/2018 Ohio State University
2018-7569 09/20/2018 EMORY SCHOOL OF MEDICINE

2018-757 01/29/2018 Excel Medical Electronics, LLC
2018-7570 09/20/2018 ET Now
2018-7571 09/20/2018 KeraLink International
2018-7572 09/20/2018 Avadel Pharmaceuticals

2018-7573 09/20/2018 FOI Services, Inc.
2018-7575 09/20/2018 THE WASHINGTON POST
2018-7576 09/20/2018 Charvi Patin
2018-7577 09/20/2018 FDA NEWS

2018-7578 09/20/2018 LEWIS AND HARRISON
2018-7579 09/20/2018 Lucas and Cardenas

2018-7580 09/20/2018 Dawn Firsing-Paris
2018-7581 09/20/2018 ET Now

2018-7583 09/20/2018 GEORGETOWN UNIVERSITY
2018-7585 09/20/2018 Synergy Health AST, LLC

2018-7586 09/20/2018 FOI Services, Inc.
2018-7588 09/20/2018 FOI Services, Inc.
2018-7589 09/20/2018 Avanos Medical
2018-759 01/29/2018 MUCKROCK NEWS
2018-7590 09/20/2018 Trophikos, LLC
2018-7591 09/20/2018 CREDIT SUISSE
2018-7592 09/20/2018 CTI Clinical Trial & Consulting Services
2018-7593 09/20/2018 FDA NEWS
2018-7594 09/20/2018 FDA NEWS
2018-7595 09/20/2018 FDA NEWS
2018-7596 09/20/2018 FDA NEWS
2018-7597 09/20/2018 FDA NEWS
2018-7598 09/20/2018 FDA NEWS
2018-7599 09/20/2018 FDA NEWS

2018-760 01/29/2018 FOI Services, Inc.
2018-7600 09/20/2018 FDA NEWS
2018-7601 09/20/2018 FDA NEWS
2018-7602 09/20/2018 FDA NEWS
2018-7603 09/20/2018 FDA NEWS
2018-7604 09/20/2018 FDA NEWS

2018-7605 09/20/2018 FOI Services, Inc.
2018-7606 09/20/2018 FDA NEWS
2018-7607 09/20/2018 FDA NEWS
2018-7608 09/20/2018 FDA NEWS
2018-7609 09/20/2018 FDA NEWS
2018-761 01/29/2018 MUCKROCK NEWS
2018-7610 09/20/2018 FDA NEWS

2018-7612 09/20/2018 NDA Partners LLC
2018-7614 09/20/2018 LOTUS CLINICAL RESEARCH LLC
2018-7615 09/20/2018 Charles River Laboratories, Inc.
2018-7616 09/20/2018 Charles River Laboratories, Inc.

2018-7619 09/20/2018 GREENBERG & TRAURIG ATTORNEYS AT LAW
2018-762 01/29/2018 MUCKROCK NEWS
2018-7620 09/20/2018 THOMPSON COBURN LLP

2018-7622 09/21/2018 Zero Point Zero Productions

2018-7625 09/21/2018 Smart World dba. Steri-Tek
2018-7626 09/21/2018 SHRADER & ASSOCIATES LLP
2018-7627 09/21/2018 FDA NEWS

2018-7629 09/21/2018 FDA NEWS
2018-763 01/29/2018 MUCKROCK NEWS

2018-7630 09/21/2018 Doe J
2018-7631 09/21/2018 jaime lester
2018-7632 09/21/2018 BLOOMBERG NEWS

2018-7633 09/21/2018 Brandon Schilling
2018-7634 09/21/2018 FDA NEWS

2018-7636 09/21/2018 FDA NEWS
2018-7637 09/21/2018 FDA NEWS
2018-7638 09/21/2018 FDA NEWS

2018-7639 09/21/2018 GUILDAY LAW
2018-764 01/29/2018 MUCKROCK NEWS
2018-7640 09/21/2018 Woolls Peer Dollinger & Scher
2018-7641 09/21/2018 FDAZILLA

2018-7642 09/21/2018 P.C.
2018-7643 09/21/2018 STOP ANIMAL EXPLOITATION NOW
2018-7644 09/21/2018 FOI Services, Inc.

2018-7646 09/21/2018 Dolat Capital Market Private Limited
2018-7648 09/21/2018 Murphy & McGonigle, P.C.

2018-765 01/29/2018 ULTRADENT PRODUCTS INC
2018-7650 09/21/2018 Freelancer - Mother Jones magazine

2018-7651 09/21/2018 KCI USA, INC.
2018-7652 09/21/2018 FOI Services, Inc.
2018-7653 09/21/2018 WRDW NEWS 12
2018-7654 09/21/2018 WRDW NEWS 12

2018-7655 09/21/2018 KCI USA, Inc.
2018-7656 09/21/2018 KCI USA, Inc.
2018-7657 09/21/2018 KCI USA, INC.
2018-7658 09/21/2018 KCI USA, INC.
2018-7659 09/21/2018 KCI USA, INC.
2018-766 01/29/2018 MUCKROCK NEWS

2018-7660 09/21/2018 Epstein Becker Green
2018-7661 09/21/2018 Oxford Performance Materials, Inc.
2018-7662 09/21/2018 Joseph McGinnis

2018-7663 09/21/2018 University of Oulu (Finland)

2018-7665 09/21/2018 KCI USA, INC.

2018-7669 09/21/2018 Datex-Ohmeda, Inc.
2018-767 01/29/2018 MUCKROCK NEWS

2018-7670 09/21/2018 Medical Alley Association
2018-7671 09/21/2018 FOI Services, Inc.
2018-7672 09/21/2018 FOI Services, Inc.
2018-7673 09/21/2018 Doe J
2018-7674 09/21/2018 MARLER CLARK LLP, PS

2018-7676 09/24/2018 BURNS WHITE CENTER
2018-7678 09/24/2018 Searcy Denney Scarola Barnhart & Shipley, P.A.
2018-7679 09/24/2018 Searcy Denney Scarola Barnhart & Shipley, P.A.

2018-768 01/29/2018 REED SMITH LLP
2018-7681 09/24/2018 FOI Services, Inc.
2018-7682 09/24/2018 FOI Services, Inc.
2018-7683 09/24/2018 FOI Services, Inc.
2018-7684 09/24/2018 FOI Services, Inc.
2018-7685 09/24/2018 Novocol Healthcare Inc.
2018-7686 09/24/2018 FDAZILLA
2018-7687 09/24/2018 Western University of Health Sciences
2018-7688 09/24/2018 Western University of Health Sciences - Pomona
2018-7689 09/24/2018 WILSON ELSER MOSKOWITZ EDELMAN & DICKER LLP

2018-7694 09/24/2018 FDAZILLA
2018-7695 09/24/2018 FDAZILLA

2018-7697 09/24/2018 TekTeam LLC.
2018-7698 09/24/2018 Weiss Asset Management LP
2018-77 01/03/2018 Folio Consulting Group, LLC
2018-770 01/30/2018 FEops NV
2018-7702 09/24/2018 Mauze Law Firm
2018-7703 09/24/2018 THINK Surgical Incorporated
2018-7705 09/24/2018 YUNGWEN KAO

2018-7707 09/24/2018 RegCon Solutions, LLC on behalf of Substipharm

2018-771 01/30/2018 Imprimis Pharmaceuticals, Inc.

2018-7712 09/24/2018 STETSON UNIV COLLEGE OF LAW
2018-7713 09/25/2018 Shelly Pearce
2018-7714 09/25/2018 ELI LILLY & CO

2018-7717 09/25/2018 FDAAWARE
2018-7718 09/25/2018 GSK Consumer Health, Inc.
2018-7719 09/25/2018 Elekta, Inc.

2018-772 01/30/2018 The Hong Kong Polytechnic University
2018-7721 09/25/2018 FDAZILLA

2018-7722 09/25/2018 FDAZILLA
2018-7725 09/25/2018 DUKE UNIVERSITY

2018-7726 09/25/2018 FOI Services, Inc.
2018-7727 09/25/2018 Centers for Pain Control and Vein Care

2018-773 01/30/2018 FOIA GROUP INC
2018-7731 09/25/2018 Odom & Des Roches LLC

2018-7733 09/25/2018 ADVITECH AND TECHNOLOGIES SA
2018-7736 09/25/2018 BLOOMBERG NEWS
2018-7737 09/25/2018 FDAAWARE
2018-7738 09/25/2018 Doe J

2018-774 01/30/2018 Elementar Americas
2018-7740 09/25/2018 FOI Services, Inc.
2018-7741 09/25/2018 CONTROLLED CHEMICALS INC

2018-7744 09/25/2018 ECOR1 CAPITAL LLC
2018-7745 09/25/2018 WOLF, ELLEN
2018-7746 09/25/2018 SCRIPPS NEWS WASHINGTON BUREAU
2018-7747 09/25/2018 VENABLE LLP
2018-7748 09/25/2018 STERIS CORP

2018-7749 09/26/2018 SafeTherapeutics LLC
2018-7750 09/26/2018 CAS Medical Systems, Inc.
2018-7753 09/26/2018 Doe J
2018-7755 09/26/2018 MBL Bion
2018-7756 09/26/2018 Ceva Animal Health
2018-7757 09/26/2018 University of Toledo Medical Center

2018-7758 09/26/2018 Fein, Such, Kahn & Shepard P.C.
2018-7759 09/26/2018 Surgivisio
2018-776 01/30/2018 ADDITION TECHNOLOGY, INC.
2018-7760 09/26/2018 CNBC Make It
2018-7761 09/26/2018 FOI Services, Inc.


2018-7764 09/26/2018 REUTERS
2018-7765 09/26/2018 FDAAWARE
2018-7766 09/26/2018 Lawrence Yang
2018-7767 09/26/2018 RQRA
2018-7769 09/26/2018 FOI Services, Inc.
2018-777 01/30/2018 C.R. Bard Inc.

2018-7770 09/26/2018 Tom Mullarkey
2018-7771 09/26/2018 DCM
2018-7772 09/26/2018 BRIGHAM & WOMEN'S HOSPITAL
2018-7773 09/26/2018 Lawrence Yang

2018-7774 09/26/2018 LSI SOLUTIONS, INC
2018-7775 09/26/2018 Doe J
2018-7776 09/26/2018 Shannon Simmons
2018-7778 09/26/2018 Trisler Consulting
2018-7779 09/26/2018 FOI Services, Inc.
2018-778 01/30/2018 KATTEN MUCHIN ROSENMAN LLP
2018-7780 09/26/2018 Joseph McGinnis

2018-7781 09/26/2018 WOODMAN, SPENCER
2018-7782 09/26/2018 THORN, JEFFREY
2018-7783 09/26/2018 DUNN GROUP INC

2018-7784 09/26/2018 Doe J
2018-7785 09/26/2018 Buzzfeed News

2018-7787 09/27/2018 NBC NEWS
2018-7788 09/27/2018 Danlei Yan
2018-779 01/30/2018 AZTACH medical device inc
2018-7790 09/27/2018 FDAZILLA

2018-7793 10/01/2018 Adams Clinical
2018-7794 10/01/2018 FDAAWARE
2018-7795 10/01/2018 Claire Tighe
2018-7796 10/01/2018 Claire Tighe

2018-7798 10/01/2018 XTAEGA LLC

2018-780 01/30/2018 Trimedyne, Inc.
2018-7800 10/01/2018 Weinberg Law Firm
2018-7801 10/01/2018 FOI Services, Inc.

2018-7802 10/01/2018 Carolyn Sampson

2018-7804 10/01/2018 Bonnie Pomerantz

2018-7806 10/01/2018 FDAZILLA
2018-7807 10/01/2018 Marsh Regional Blood Center
2018-7808 10/01/2018 Alicia Antiri

2018-781 01/30/2018 FOI Services, Inc.
2018-7811 10/01/2018 Alicia Antiri
2018-7812 10/01/2018 Alicia Antiri

2018-7813 10/01/2018 Teri Santucci
2018-7814 10/01/2018 Alicia Antiri
2018-7815 10/01/2018 Alicia Antiri
2018-7816 10/01/2018 Alicia Antiri

2018-7818 10/01/2018 Dr Ajay Phadke
2018-7819 10/01/2018 Alicia Antiri

2018-782 01/30/2018 Doe J
2018-7821 10/01/2018 Alicia Antiri
2018-7822 10/01/2018 REUTERS

2018-7823 10/01/2018 Xcelience LLC
2018-7825 10/01/2018 FDA Quality & Regulatory Consultants LLC
2018-7826 10/01/2018 FDA Quality & Regulatory Consultants LLC


2018-783 01/30/2018 MEDTRONIC, INC.
2018-7831 10/01/2018 Genomic Health

2018-7835 10/01/2018 PHARMA MAR SA

2018-784 01/30/2018 Sandra Bartlett
2018-7841 10/01/2018 JeniVision Inc.


2018-7845 10/01/2018 (DICE)
2018-7846 10/01/2018 SUZUKEN CO LTD


2018-785 01/30/2018 FOI Services, Inc.

2018-7858 10/01/2018 Prosight Capital
2018-7859 10/01/2018 Prosight Capital

2018-786 01/30/2018 FOI Services, Inc.

2018-7862 10/01/2018 Compliance Specialists LLC
2018-7863 10/01/2018 Resistell
2018-788 01/30/2018 Doe J
2018-789 01/30/2018 Madris Tomes - Employee of FDA/CDHR/OSB/DPS/IAB

2018-791 01/30/2018 ADB Interests, LLC
2018-792 01/30/2018 Device Events

2018-793 01/30/2018 MERGE HEALTHCARE
2018-794 01/30/2018 JONES DAY
2018-795 01/30/2018 JONES DAY

2018-796 01/30/2018 Mumbai
2018-797 01/31/2018 U.S. Right to Know

2018-798 01/31/2018 FOI Services, Inc.
2018-799 01/31/2018 Perkins Coie LLP
2018-8 01/02/2018 Sterne, Kessler, Goldstein & Fox

2018-80 01/03/2018 Registrar Corp
2018-802 01/31/2018 Bryan Sullivan
2018-803 01/31/2018 Burdock Group Consultants
2018-804 01/31/2018 Tremont Therapeutics Consulting

2018-806 01/31/2018 Carissa Rossi

2018-808 01/31/2018 WilMarc Medical
2018-809 02/01/2018 FDAAWARE

2018-81 01/03/2018 Eurofins
2018-810 02/01/2018 Takeda Pharmaceutical Company Limited
2018-811 02/01/2018 Puma Biotechnology, Inc.
2018-812 02/01/2018 FOI Services, Inc.
2018-814 02/01/2018 Patients For Affordable Drugs

2018-816 02/01/2018 The Rosen Law Firm

2018-818 02/01/2018 Aavis Pharmaceuticals
2018-819 02/01/2018 Theresa M Labbe, MD
2018-82 01/03/2018 Gardner Law, PLLC
2018-823 02/01/2018 Doe J

2018-825 02/01/2018 FOI Services, Inc.
2018-826 02/01/2018 BALYASNY ASSET MANAGEMENT
2018-827 02/01/2018 Device Events

2018-828 02/01/2018 Sam Edland
2018-83 01/03/2018 Paritic Inc.
2018-830 02/01/2018 Reuters News
2018-832 02/01/2018 Matt Philippe

2018-833 02/01/2018 Reuters News
2018-835 02/01/2018 Theresa M Labbe, MD
2018-836 02/01/2018 Cadian Capital

2018-837 02/01/2018 Pharmobedient Consulting LLC
2018-838 02/01/2018 MEDICAL UNIVERSITY OF SOUTH CAROLINA
2018-839 02/01/2018 ECOLAB INC

2018-840 02/01/2018 MAZEL EQUITIES NATIONAL ASSOCS
2018-841 02/01/2018 KEYS 22458-017, CLAY
2018-842 02/01/2018 BLANK ROME LLP
2018-844 02/01/2018 KIRKLAND & ELLIS LLP

2018-845 02/01/2018 DOLL 230225, GERALD LEE
2018-846 02/01/2018 BOERSCH SHAPIRO ET AL
2018-849 02/01/2018 RUTGERS SHCHOOL OF PUBLIC HEALTH
2018-85 01/03/2018 MENKES, MICHAEL
2018-850 02/02/2018 SYSMEX AMERICA INC


2018-854 02/02/2018 CONWAY HOMER PC
2018-855 02/02/2018 Bemis Company, Inc.
2018-856 02/02/2018 AccelaPHARMA, LLC
2018-857 02/02/2018 Registrar Corp
2018-859 02/02/2018 Oxford & Wells
2018-86 01/03/2018 Gardner Law, PLLC
2018-860 02/02/2018 Westwood Advisors Incorporated

2018-863 02/02/2018 Aesthetic Exploration
2018-864 02/02/2018 Bemis Company, Inc.
2018-865 02/02/2018 Institute of Pharmacy, Nirma University, India
2018-867 02/02/2018 Alicia Antiri

2018-869 02/02/2018 Med-Pharmex, Inc

2018-87 01/03/2018 Registrar Corp
2018-870 02/02/2018 Imprimis Pharmaceuticals, Inc.
2018-871 02/02/2018 Med-Pharmex, Inc
2018-872 02/02/2018 Debra Bennett
2018-874 02/02/2018 BLOOMBERG NEWS
2018-875 02/02/2018 LEE & HAYES

2018-877 02/02/2018 FOI Services, Inc.

2018-878 02/02/2018 STRYKER ORTHOPAEDICS

2018-88 01/03/2018 Gardner Law, PLLC

2018-884 02/02/2018 Penn Law LLC
2018-886 02/02/2018 Cutera, Inc.
2018-887 02/02/2018 WEST, AMY

2018-888 02/02/2018 Jon Knight
2018-89 01/03/2018 Mark Schafer
2018-890 02/02/2018 Penn Law LLC

2018-892 02/02/2018 NAPP TECHNOLOGIES LLC
2018-893 02/02/2018 RECORDATI RARE DISEASES INC

2018-894 02/02/2018 KUENY, TODD R
2018-896 02/05/2018 Russ Kick

2018-897 02/05/2018 Bloomberg News
2018-898 02/05/2018 STAT
2018-899 02/05/2018 HENDERSON, TITUS
2018-9 01/02/2018 CITADEL LLC
2018-90 01/03/2018 Columbia Journalism School
2018-901 02/05/2018 Doe J
2018-904 02/05/2018 HAW-DU-I FOODS CO., LTD

2018-906 02/05/2018 Bio-Pharm, Inc
Medivators Inc./SPS Medical subsidiary of
2018-908 02/05/2018 Crosstex Inc.
2018-91 01/03/2018 ELLIS, PAM
2018-910 02/05/2018 JANNEY MONTGOMERY SCOTT LLC
2018-911 02/05/2018 CR BARD INC.
2018-912 02/05/2018 Kirkland and Ellis LLP

2018-913 02/05/2018 UNC HEALTH CARE DIABETES CARE CENTER

2018-915 02/05/2018 Quinn Eastman
2018-919 02/05/2018 BAKER & HOSTETLER, LLP
2018-92 01/03/2018 Chardan
2018-921 02/05/2018 EBRC Consulting GmbH

2018-922 02/05/2018 FOI Services, Inc.
2018-923 02/05/2018 Food Industry Counsel LLC
2018-924 02/05/2018 Shegerian & Associates, Inc.

2018-925 02/05/2018 P & L Developments, LLC
2018-926 02/05/2018 Doe J
2018-927 02/05/2018 FOI Services, Inc.
2018-928 02/05/2018 margaret groel
2018-929 02/05/2018 CARDIOVASCULAR BIOTHERAPEUTICS INC

2018-93 01/03/2018 MUCKROCK NEWS
2018-931 02/05/2018 MUSICK PEELER & GARRETT LLP

2018-932 02/05/2018 COOK ANIMAL HEALTH
2018-933 02/05/2018 William Coogan - CARA Therapeutics
2018-934 02/05/2018 Michelle Boucher
2018-935 02/05/2018 Conair Corporation

2018-939 02/05/2018 FOIA GROUP INC
2018-94 01/03/2018 LACHMAN CONSULTANT SERVICES INC

2018-941 02/05/2018 MORGAN LEWIS & BOCKIUS LLP
2018-942 02/05/2018 Wilkes & McHugh, PA

2018-944 02/05/2018 FOI Services, Inc.
2018-946 02/05/2018 Russ Kick
2018-947 02/05/2018 Department of Finance, Insurance, and Real Estate

2018-95 01/03/2018 LABTHERMICS TECHNOLOGIES
2018-950 02/05/2018 DCCC
2018-951 02/05/2018 Doe J
2018-952 02/05/2018 FOI Services, Inc.
2018-953 02/06/2018 PIPER JAFFRAY & CO
2018-954 02/06/2018 CAM

2018-958 02/06/2018 WVMIC

2018-959 02/06/2018 FOIA GROUP INC
2018-96 01/03/2018 Columbia Journalism School
2018-960 02/06/2018 Elucid Bioimaging Inc.
2018-961 02/06/2018 Elucid Bioimaging Inc.
2018-962 02/06/2018 margaret groel
2018-963 02/06/2018 margaret groel
2018-964 02/06/2018 margaret groel

2018-966 02/06/2018 margaret groel
2018-968 02/06/2018 Reuters News

2018-969 02/06/2018 PBS Regulatory for LOBSOR
2018-97 01/03/2018 ANGYAL, DORIS
2018-970 02/06/2018 Prateek Goyal
2018-971 02/06/2018 OrthoPediatrics, Corp
2018-972 02/06/2018 RAY THOMPSON
2018-973 02/06/2018 RAY THOMPSON

2018-974 02/06/2018 RAY THOMPSON
2018-975 02/06/2018 RAY THOMPSON
2018-976 02/06/2018 Reuters News

2018-977 02/06/2018 PBS Regulatory Consulting Group for Axcella
2018-978 02/06/2018 RAY THOMPSON
2018-979 02/06/2018 RAY THOMPSON

2018-98 01/03/2018 GOTOP Medical
2018-980 02/06/2018 RAY THOMPSON
2018-981 02/06/2018 PharmaTech LLC
2018-982 02/06/2018 margaret groel
2018-983 02/06/2018 West Bend Mutual Insurance

2018-984 02/06/2018 PharmaTech LLC
2018-985 02/06/2018 Hong Kong Polytecnic University
2018-986 02/06/2018 Think Investments LP

2018-988 02/06/2018 MARTIN GANOTIS BROWN MOULD & CURRIE PC
2018-989 02/06/2018 KELLEY, MEGAN JEAN
2018-990 02/06/2018 JANTAR GMBH
2018-993 02/06/2018 POINTSTATE CAPITAL LP

2018-994 02/06/2018 BLOOMBERG NEWS
2018-996 02/06/2018 Cherrystone Hill Capital Management LLC
2018-997 02/06/2018 STAT
Subject
SUN PHARMA, BASKA, INDIA - 483 10/01/2017 - 11/22/2017

TITANIUM DIOXIDE - AERS, CAES 9/04 TO 11/17
CORR BETWEEN FDA AND NOXBOX LTD RE NOXIBOXI DEVICE 01/01/2017 -
11/21/2017
CORTICOTRPIN ACTHAR MEDWATCH FAERS 01/01/2010 - 12/31/2016
INDIVIDUAL RECS
NDA 050615 SBA
FCN 1582
FCN 972
LIST OF DRUG INSPECTIONS 02/15/2017 - 11/27/2017
Ultralite Enterprises Form 3801 Product Reports or Supplemental
Reports under 21 CFR 1002.10 and 1002.12
DR REDDY'S, DUVVADA, INDIA - EIR 03/01/2017 - 11/21/2017
CORR BETWEEN FDA AND DEA RE KRATOM RECS RE 36 REPORTS OF DEATH
08/01/2016 - 11/22/2017
EUROPHARMA CO, INC - CORR WITH FDA RE CURAMIN, WARNING LETTER

STERIGENICS, CORONA, CA - EIR 04/18/2017 - 04/18/2017
DR REDDY'S LABORATORY, DUVVADA - EIR 11/01/2017 - 11/22/2017

RECS RE WELLS PHARMACY NETWORK, LLC, OCALA, FL
NEXIUM, PREVACID, PREVACID IV, ETC RECS RE CHRONIC KIDNEY
DISEASE 01/01/2010 - 11/21/2017
NDA 008317 SBA
PREVASID AERS
K160309
NDA 020363
2015-24 2015-25 2015-175 2015-176 ETC
NDA 208630
NUMBER OF ELECTRONIC NICOTINE DELIVERY SYSTEM PRODUCTS
MANUFACTURED IN US LISTED WITH AGENCY AS OF 11/21/17
DIVI'S LABORATORIES, INDIA - EIR 08/01/2017 - 11/21/2017
DR REDDY'S FORM 145 LETTER DUVADDA, INDIA 11/01/2017 -
11/21/2017
K120446
K970685
RECS RE COMBINEWD SAFETY AND EFFICACY OF IMMUNOGLOBULIN
INTRAVENOUS 01/01/2000 - 12/31/2017
1999P-1268
SUN PHARMACEUTICALS, BASKA, INDIA - 483 11/09/2017 - 11/21/2017

COMMUNICATIONS RE MD-2018-002-VPH LIST OF ELIGIBLES FOR FDA-
CDER-17-MP-1989132
BIOCON LIMITED - 483 04/01/2017 - 11/21/2017
K031327
FAP 4M4428
MEDICAL EQUIPMENT SOLUTIONS INC, NORTH KANSAS CITY, MO - 483
ELEKTA INC, MARYLAND HEIGHTS, MO - 483 05/09/2016 - 02/10/2017
ZIMMER BIOMET, WARSAW, IN - 483, RESPONSE 01/01/2014 -
11/22/2017
PHILIPS, CLEVELAND, OH - 483 01/01/2014 - 11/22/2017
INDIVIDUAL RECS
Any and all questions issued by the FDA to Boston Scientific

Corporation regarding Marlex-HGX-030-01 and the answers issued
by Boston Scientific Corporation in response thereto 01/01/2008
- 12/31/2012
HHSF223201400663G
DEN150028
DPremarket Notification Application by Boston Scientific

Corporation for surgical mesh products identified by trade
names Obtryx, Pinnacle, Solyx, Lynx, Uphold, Pinnacle Lite,
Obtryx II, Advantage, Prefyx and Uphold Lite
LE CHATELARD 1802, FRANCE REGISTRATION RECS 05/01/2016 -
11/25/2017
RECS RE PERIPHERAL ARTERIAL TONOMETRY SIGNAL
K162042
EMAILS TO AND FROM APPLE 1/17 TO 11/27/17
DOCKET O1P-0108
PHS EMPLOYEE OF SEAGOVILLE, TX FCI - DISCIPLINARY RECS
DAILY LOG 10/16-20/17
DAILY LOG 10/23-27/17
DAILY LOG 10/30/17-11/03/17
DAILY LOG 11/6-10/17
DAILY LOG 10/16-20/17
DAILY LOG 10/23-27/17
DAILY LOG 10/30/17-11/3/17
DAILY LOG 10/16-20/17
DAILY LOG 10/23-27/17
DAILY LOG 10/30/17-11/3/17
DAILY LOG 10/16-20/17
DAILY LOG 10/23-27/17
DAIILY O LOG 10/30/17-11/3/17
DAILY LOG 10/16-20/17
DAILY LOG 10/23-27/17
DAILY LOG 10/30/17-11/13/17
DAILY LOG 10/16-20/17
DAILY LOG 10/23-27/17
DAILY LOG 10/30/17-11/3/17
DAILY LOG 10/16-20/17
DAILY LOG 10/23-27/17
DAILY LOG 10/30/17-11/3/17
CLODED LOG 10/16-20/17
CLOSED LOG 10/23-27/17
CLOSED LOG 10/30/17-11/3/17
CLOSED LOG 10/30/17-11/3/17
CLOSED LOG 10/30/17-11/3/17
CLOSED LOG 10/30/17-11/3/17
CLOSED LOGS 11/6-10/17
DAIL LOG 11/6-10/17
GENEA BIOMEDX DATE OF REGISTRATION EMD SERONO 08/16/2016 -
11/22/2017
PSILOCYBIN, DIMETHYLTRYPTAMINE, LSD CLINICAL TRIAL RECS
11/21/2007 - 11/21/2017
LIMBREL AERS, MEDWATCH
MEDWATCH 8966611 & 13688650
RLD container labels for SINEQUAN (Doxepin HCl)
NDA 12373
NDA 016851
RECS RE 36 KRATOM RELATED DEATHS
NDA 020126
SCOTT DANZIS CORR TO DDMAC RE TESTOPEL 01/01/2009 - 12/31/2010

LEVAQUIN, CIPRO ADVERSE EVENTS 11/01/2002 - 11/01/2017
AUROBINDO UNIT 10, INDIA - 483 11/01/2017 - 11/24/2017
K980987 K110771
DEATH REPORTS KRATOM 01/01/1900 - 11/14/2017
STATUS OF ANDA
KRATOM AERS 01/01/2015 - 06/30/2017
CORR DDMAC RE LETTER FROM SHELDON BRADSHAW TESTIM ANDROGEL
01/01/2010 - 12/31/2013
K153727
K860812
COGNITIVE RESEARCH CORPORATION, ST PETERSBURG, FL - EIR
07/10/2017 - 11/27/2017
I-2008-P-0200
LUPIN LIMITED - 483, RESPONSE 03/27/2017 - 04/07/2017
K963183
K001408
JEROME STEVENS PHARMACEUTICALS, BOHEMIA, NY - 483 01/01/2017 -
11/27/2017
BIOCON LTD, BANGALORE, INDIA - EIR 05/24/2017 - 11/28/2017
GLENMARK PHARMA, BADDI, INDIA - 483 11/01/2017 - 11/28/2017
K070374
K160669
K162608
FEED, PET FOOD INGREDIENTS AAFCO 2017 11/01/2017 - 11/27/2017

ICON, NORTH WALES, PA - EIR 05/15/2015 - 05/15/2015
NCT01183312
ANDA 208824 TENTATIVE APPROVAL LETTER
AXIS CLINICAL LLC, DILWORTH, MN - EIR 07/31/2017 - 08/04/2017

LIST OF INSPECTIONS Oct 1st - Nov 31st 2017
REPRO-MED SYSTEMS INC, CHESTER, NY - EIR 10/02/2017 -
10/19/2017
NDA 209472 TENTATIVE APPROVAL LETTER
EPIPEN RECORDS
K882963
K121481
K122652
K102409
FOIA requests regarding K050114
2017-6170
2017-9210
2017-9211
2017-9554
INDIVIDUAL RECS
2017-9617
FDA FOIA LOG ABBOTT LABORATORIES 11/01/2017 - 11/28/2017
K102581
K101314
K101786
K102082
FDA RESP TO THE WORLD HEALTH ORGANIZATION (WHO) REQUEST FOR
MEMBER STATE FEEDBACK ON SUBSTANCES UNDER EVALUATION DURING THE
39TH MTG OF THE WHO EXPERT COMMITTEE ON DRUG DEPENDENCE
EIR EXHIBITS
PARKE-DAVIS/PFIZER INC - DILANTIN (PHENYTOIN) AERS, RISK
ASSESSMENTS, SAFETY SIGNAL ANALYSES, ETC
LEVACET, SOMA COMPUND, TALWIN, ETC - RECS
BUSPAR, WELLBUTRIN, EFFEXOR, ETC
SURETEK MEDICAL - MEDICAL REPROCESSED ELECTROSURGICAL
ELECTRODES K052692
MYPLATE PORTIONS LIST, FLA DEPT OF CORRECTIONS CURRENT REGULAR
MENU
FOIA RELEASED EIR 11/01/2017 - 11/30/2017
483 RELEASED UNDER FOIA 11/01/2017 - 11/30/2017
NDA 050615 SBA
IND 51209
K140068 K014099 K151545 ETC
RECS RE STATEMENT RE CHRONIC KIDNEY DISEASE AND PPIS
FCN 865
NDA 021514 ANNUAL REPORT INFORMATION
RECS RE NCT02955264, NCT02089789
IND 62036
ULORIC AERS
IND 113334
VASCEPA IND 01/01/1962 - 12/31/1990
K001275
NDA 007513 SBA
RECS RE PERFLUOROOCTANOIC ACID 01/01/2007 - 11/01/2017
NDA 021585 APPROVAL LETTER
NDA 05060 SBA
NDA 020363 FAMVIR SBA
PHILIPS MEDICAL SYSTEMS, INC, CLEVELAND, OH - EIR 01/01/2017 -
11/27/2017
FEBUXOSTAT VS ALLOPURINOL FOR CARDIOVASCULAR RISK SAFETY TRIAL
11/01/2016 - 11/15/2017
12342563 12342556 12347134 5907731 ETC
FDA FOIA LOG ST JUDE MEDICAL 11/01/2017 - 11/28/2017
ANALYSIS OF GLYPHOSATE AND ACID HERBICIDES - RECS, EMAILS, ETC
06/01/2017 - 11/28/2017
12904567, 13193696, 13159955, ETC
NDA 022023
ANDA 040859
GLENMARK BADDI, INDIA - 483 11/01/2017 - 11/29/2017
CORR WITH ENDOLOGIX INC RE PRE MARKET APPROVAL OF NELLIX EVAS
SYSTEM 01/01/2017 - 11/29/2017
HEPATITIS A CASES HAWAII 01/01/2010 - 01/01/2017
NDA 202090 COMPLETE RESPONSE LETTER
OL LOG - CONGRESS MEMBERS 1/1/13 TO PRESENT
TEVA PHARMACEUTICAL INDUSTRIES - DIAZOXIDE ORAL SUSPENSION NDA
7D7428 SBA
IOVATE, HYDROXYCUT, CREATINE, ETC - CAERS
AMGEN - ROMOSOZUMAB (AMG-785) FDA WORK PAPERS, MEMOS, LTRS, ETC

SOS LTD - HYPERLITE K905168
LOPERAMIDE - MEDWATCH FORMS 3500 2016-2017
ARTHROCARE CORP - ARTHROCARE ENT PLASMA WANDS K033257
SALTO TALARIS K060544 WRIGHT MEDICAL INFINITY TOTAL ANKLE SYS
K123954 TOPEZ TOTAL ANKLE SYS K051023
FLORIA STATE REP MIKE MILLER - CORR 1/1/13 TO 10/16/17
REVERSING EPIGENETIC & OTHER MARKERS OF SENESCENCE BY
TRANSFUSING YOUNG PLASMA TO OLDER HUMAN SUBJECTS
ISOPTIN (VERAPAMIL HCL) INJ NDA 18-485 PRIMACOR (MILRINONE
LACATE) INJ NDA19-436 THORAZINE (CHLORPROMAZINE HCL) INJ
NDA09-149, ETC - LBLG
INTEGRATED BIOMEDICAL CORP - ALGONIX ELECTRO-EQUISCOPE
TECHNICAL RECS, RISK MANAGEMENT FILE
CORR FROM OR TO JOE GROGAN, OFFICE OF COMMISSIONER 01/01/2006
- 01/01/2009
2003-3755
2003-3824
2003-5771
2003-6667
2003-7069
2003-7221
2003-7340
SHILPA MEDICARE, TELANGANA, INDIA - 483 11/21/2017 - 11/30/2017

DAEWOONG PHARMACEUTICAL COMPANY LTD, KOREA - 482 09/01/2017 -
11/30/2017
2003-7997
2003-8486
DR REDDY WARNING LETTERS, 483, EIR ETC 01/01/2011 - 11/29/2017

MOHAMED BIDAIR SAN DIEGO UROLOGY CTR, LA MESA, CA - 483
03/02/2011 - 11/29/2017
RAYMOND BELL, MOBILE MED & DIAG CTR, MOBILE, AL - 483
01/01/2010 - 11/29/2017
GLIADEL IND ETC 01/01/1986 - 12/31/2000

2003-3743
BLOCKED TWITTER ACCOUNTS 12/04/2017 - 12/06/2017
LIMBREL HHE
STAFF WORKING IN CDER DIV OF ANESTHESIA ETC
CAP 8C0075 RECS RE ATTEMPT TO EXPAND USE ULTRAMARINE AS
APPROVED TOPICAL DRUG PRODUCT
RECS RE NATURAL COLORANT INDIGO 01/01/1976 - 11/30/2017
PHILIP MORRIS PRODUCTS SA, SWITZERLAND PHILIP MORRIS
MANUFACTURING AND TECHNOLOGY BOLOGNA SPA, ITALY LABSTAT,
CANADA ETC - EIR
COMPLAINT INFORMATION
ANDA 203351
ANDA 203631
CHALLENGE WAREHOUSING, INC, FORT LAUDERDALE, FL - 483
01/01/2010 - 12/31/2010
ZIMMER BIOMET HOLDINGS, PR - 483, WARNING LETTER, EIR
05/01/2012 - 11/30/2017
RECS RE 510K HEART DEVICES BY HEART TEST LABORATORIES, INC
01/01/2012 - 11/30/2017
K161212
NDA 019123 LABELING
2003-3743
NDA 020974 LABELS
DR AZRA RAZA, RUSH UNIVERSITY IRB - EIR 08/17/2001 - 08/17/2001

2003-8958
DAVID LEIMAN, HOUSTON, TX - EIR 483 ETC
GLENMARK PHARMACEUTICALS, INDIA - 483, EIR, EIR 01/01/2016 -
11/30/2017
INDIVIDUAL RECS
FAP 2286
CYBERONICS P970003, MDR, WARNING LETTERS ETV 07/01/2004 -
11/30/2017
CFSAN CORR RE STANDARD OF IDENTITY FOR NOODLES
INDIVIDUAL RECS
NDA 020049
K160339
CORR BETWEEN JOE GROGAN AND SENIOR POLICY ADVISORS TO
COMMISSIONER OF FDA 01/01/2011 - 01/01/2012
CHIPOTLE MEXICAN GRILL INC - FOOD SAFETY ISSUES REGARDING E
COLI, SALMONELLA, NOROVIRUS, ETC
NDA 209-112 - ORPHAN DRUG EXCLUSIVITY DETERMINATION
DELTA-9-TETRAHYDROCANNIBINOL AND CANNABIDIOL BACLOFEN AND
GLATIRAMER ACETATE FO R INJ - ORPHAN DRUG DESIGNATION
PERFORMANCE ENHANCING DRUGS, DIETARY SUPPLEMENTS
CRF FROZEN FOODS LLC, PASCO, WA - EIR EXHIBITS, ATTACHMENTS
01/01/2012 - 11/30/2017
COUMADIN - SAFETY ALERT, DECISION ANALYSIS, FDA POLICIES, ETC

APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS
33RD TO 36TH EDITIONS
CELLTRION, INCHEON, KOREA - 483 06/01/2017 - 11/30/2017
CELLTRION, INCHEON, KOREA - 483 OR FMD 145 01/01/2015 -
11/01/2015
LEVAQUIN, CIPRO, AVELOX - AERS
2003-9912
BECKMAN COULTER, MIAMI, FL - 483 01/01/2017 - 11/30/2017
K171120
NERLYNX AERS
DR IMRE MOHAR - HHSF223201510597A, HHSF2230140303A, RETAINER
AGREEMENTS, CONSULTING AGREEMENTS
NORTHGATE TECHNOLOGIES, INC, ELGIN, IL - EIR 05/01/2017 -
11/30/2017
SHILPA MEDICARE LTD, INDIA - 483 11/20/2017 - 12/01/2017
NOS WERKS, LOS ANGELES, CA - NITROUS OXIDE EXPLOSION
INVESTIGATION 6/13/12
AMERICAN PHARMACEUTICAL INGREDIENTS, WATERFORD, MI - EIR, 483,
WARNING LETTER 01/01/2015 - 12/31/2015
K9208408 FIRST PARTY
INSTITUTION/DISEASE ORIENTED ADVERTISEMENT GUIDANCE 05/01/1988
- 12/31/1988
CONSUMER COMPLAINT 150674 RECS
PHILIPS ULTRASOUNDS, PHILIPS RESPIRONICS, PHILIPS ELECTRONICS

NORTH AMERICAN CORPORATION ETC - 483 01/01/2013 - 11/30/201
FOIA REQUEST FILES
NDA 021999 SBA
ROHTO PHARMACEUTICAL COMPANY LTD, JAPAN - 483 11/01/2014 -
12/31/2014
2017-6719, 2017-6281, 2016-10412, ETC
SECURITY RECS 10/23/2017 - 10/23/2017
UNION CAMP CORPORATION LETTER TO FDA RE VANILLA HYBRIDS,
RESPONSE 01/01/1990 - 12/31/1999
ORANGE BOOK RECS 01/01/2000 - 12/31/2009
ORANGE BOOK RECS 01/01/1980 - 12/31/1999
CHANGZHOU SUNLIGHT PHARMACEUTICAL CO LTD EIR, 483, CAPA
07/04/2011 - 12/01/2017
XELLIA PHARMACEUTICALS LTD, HUNGARY - EIR, 483, CAPA 12/01/2014
- 12/01/2017
K043401
ASTELLAS PHARMA TECH CO LTD, JAPAN LONZA BIOLOGICS, SPAIN
CILAG AG, SWITZERLAND - 483 09/05/2016 - 05/19/2017
NORTH CHINA PHARMACEUTICAL CO LTD - EIR, 483, CAPA 09/07/2015 -
09/11/2015
NOVA BIOMEDICAL CORPORATION, WALTHAM, MA - 483 04/04/2017
PHILIPS ELECTRONICS NORTH AMERICA, ANDOVER, MA - 483
12/14/2010
AMERICAN HEALTH PACKAGING, COLUMBUS, OH - 483 06/15/2017 OHIO
LAB, CINCINNATI, OH - 483 09/28/2017 FRESENIUS MEDICAL CARE
NORTH, OREGON, OHIO - 483 06/30/2017
K141991
K172520
NDA 050703
BUTTERFLY PEA FLOWER AS COLOR ADDITIVE OR FOOD ADDITIVE
SHILPA MEDICARE, INDIA - 483 11/01/2017 - 12/01/2017
EDGE PHARMACY SERVICES LLC, COLCHESTER, VT - MEETING MINUTES,
RECS FROM MEETING 10/01/2017 - 12/01/2017
ORANGE BOOK RECS 01/01/2006 - 12/01/2008
AMNEAL PHARMACEUTICALS LLC, PATERSON, NJ - 483 10/01/2017 -
10/31/2017
K151511, K151359, K101791, ETC

CORR BETWEEN ALEX AZAR AND ROBERT TEMPLE 01/01/2007 -
12/01/2017
510K INTEGRA, CUSA CLARITY, CUSA NXT, CUSA EXCEL+ ETC
K071066
STAAR SURGICAL COMPANY, MONROVIA, CA - 483 01/01/2007 -
12/01/2017
Bravecto (fluralaner) Chewable Tablets 18 month adverse event
review document compiled by CVM, Division of Veterinary Product
Safety (HFV-240) team.
INVESTIGATION REPORT CDER/OPQ 06/01/2016 - 12/31/2016
SICHUN FRIENDLY PHARMACEUTICAL CO LTD, CHINA - 483, EIR,
RESPONSE
AMRI, ITALY - 483, RESPONSE 02/01/2017 - 05/31/2017
BLA 125522, SBA S 13, 14
K001338
Nonclinical and clinical review information for intravesical

TICE BCG (Manufacturer: Organon Teknika Corp., LLC)
RECS RE JOSEPH JOEY MUNINGER, NEWPORT NEWS, VA COMPLAINT
10/24/2017 - 12/01/2017
LIST OF VCRP PRODUCTS THAT HAVE LISTED TALC AS AN INGREDIENT l

SYN-TECH CHEMICAL & PHARMACEUTICAL CO LTD, TAIWAN - EIR, 483,
CAPA 01/26/2015 - 01/29/2015
LIST OF INSPECTIONS, CITATIONS 12/01/2016 - 12/01/2017
ALEX AZAR CORR WITH JANET WOODCOCK 01/01/2007 - 12/01/2017
DR REDDY DUVAADA, INDIA - EIR 01/01/2017 - 12/01/2017
ALPHA TEKNOVA INC, HOLLISTER, CA - 483 01/09/2017 - 06/21/2017
CHARLES RIVER LABORATORIES PRECLINICAL SERVICES, RENO, NV -
483 05/26/2017
SHILPA MEDICARE, MEDCHERLA, INDIA - 483 11/20/2017 -
12/04/2017
AERS, ADVISORIES, WARNING LETTERS VIVITROL 01/01/2015 -
12/01/2017
PHILIPS MEDICAL SYSTEMS, CLEVELAND, OH - 483 06/01/2017 -
12/04/2017
CC 151151
8158672, 11937951, 13644396 MEDWATCH RECS
NATURAL ESSENTIALS INC, STREETSBORO, OH - INSPECTION RECS
07/01/2016 - 12/04/2017
NDA 205004 SUMMARY REVIEW
VYZULTA SBOA
SUBOXONE AERS, ADVISORIES, WARNING LETTERS 01/01/2015 -
12/01/2017
K171816
NDA 207202
CORR BETWEEN DR LESTER M CRAWFORD AND FORMER HHS GENERAL
COUNSEL ALEX AZAR RE OTC AVAILABILITY OF LEVONORGESTREL, PLAN B
02/25/2002 - 04/28/2006
DAILY LOG 11/13-17/17
DAILY LOG 11/20-24/17
DAILY LOG 11/13-17/17
DAILY LOG 11/20-24/17
DAILY LOG 11/13-17/17
DAILY LOG 11/20-24/17
DAILY LOG 11/13-17/17
DAILY LOG 11/20-24/17
DAILY LOG 11/13-17/17
DAILY LOG 11/20-24/17
DAILY LOG 11/13-17/17
DAILY LOG 11/20-24/17
DAILY LOG 11/13-17/17
DAILY LOG 11/20-24/17
EMAIL BETWEEN JAKE TODD AND MATTHEW HOLMAN 01/01/2017 -
11/30/2017
ENFORCEMENT REPORT DATA
K926508
ANASTHETIC AND ANALGESIC DRUG ADVISORY COMMITTEE MEETING VIDEO
12/7/12
FDA-2008-P-0201
WARNING LETTER SPREADSHEET 10/01/2011 - 11/30/2011
FDA Food and Beverage Recall tonnage for 2016. Entire U.S.
recalled food and beverage recall tonnage, by manufacture
origin, if possible. 01/01/2016 - 12/01/2016
DRUG MASTER FILE SPREADSHEET 01/01/1997 - 12/31/1997

K161194
LOG OF CLOSED REQUESTS FOR 483 2017
MILK DRUG RESIDUE DATABASE MANAGEMENT CONTRACT, FINAL PROPOSAL
12/01/2007 - 12/01/2017
SHILPA MEDICARE TELANGANA, INDIA - 483 12/01/2017 - 12/05/2017

SHILPA MEDICARE LIMITED, JADCHERLA, TELANGANA, INDIA - 483
12/01/2017 - 12/05/2017
RESPONSE FROM FDA TO CENTER FOR SCIENCE IN THE PUBLIC INTEREST

LETTER RE NO ADDED SUGAR LABELS ON 100% JUICE PRODUCTS
RESPONSE TO LETTER SENT BY JUICE PRODUCTS ASSOCIATION RE NO
ADDED SUGAR ON 100% JUICE PRODUCTS GUIDANCE, ETC
ANDA 084612
OFFICE OF LEGISLATION CORR WITH SEN JOHNNY ISAKSON 2016-2881,
2015-5755, 2015-1126
ANDA 040771, ANDA 205592, ANDA 206312
K151426
ECT DEVICE SOMATICS LLC EFFICACY AND SAFETY OF ECT 1997
K141148, K142301, K150360, ETC
ORKAMBI DEATH REPORTS
LIST OF INSPECTIONS 2017
GAMMA GUIDANCE SYSTEM MEDICAL DEVICE 510K
DAEWOONG, KOREA - 483 11/01/2017 - 12/05/2017
K062176
PREVIOUSLY RELEASED 483, RESPONSE, EIR 2017
SHILPA MEDICARE TELANGANA - 483 11/27/2017 - 12/05/2017

PHILIPS MEDICAL SYSTEMS, INC, CLEVELAND, OH - 483 07/17/2017 -
08/18/2017
LIFECORE BIOMEDICAL, CHASAKA, MN - INSPECTION RECS 01/01/2015 -
12/05/2017
FOIA LOG 2017
BIOAGILYTIX, DURHAM, NC - EIR, 483 11/01/2015 - 11/28/2017
NEXIUM, PRILOSEC, PROTONIX, ETC - AER
PRILOSEC, NEXIUM, PROTONIX, ETC - DDMAC FILE
PRILOSEC, NEXIUM, PROTONIX, ETC - NDA, ANDA
PRILOSEC, NEXIUM, PROTONIX, ETC - CLNCL TRIALS, STUDY
PROTOCOLS, PHARMACOVILIGANCE RECS, ETC
K113294
VIDA DIAGNOSTICS, CORALVILLE, IA - INSP 10/3/16
ST JOSEPH HOSPITAL, DR JASON BRADKEY - CMPLNT
ST JUDE MEDICAL AMPLATZER PATENT FORAMEN OVALE OCCLUDER MTG
5/24/16
LUPRON - PEDIATRIC RVWS
BOTULINUM STRAIN USED TO PRODUCE DWP-450 - DOCS
HALLUCINOGEN APPLICATIONS APPROVED & UNAPPROVED 1945 TO 2017

LYRICA CR (PREGABALIN) APRVL NDA 09501
PFIZER - DILANTIN (PHENYTOIN) EFFICACY, LBLG NDA 08-762/S055
NDA 10151/S042
MIRAPEX (PRAMIPEXOLE) LBLG
DAILY LOG SINCE 9/2017
FORMS SEE LIST
FBI FILE FOR DANIEL DUCHAINE
FLUARIX PFS QUAD 2015-16 INJ, 0.5 ML, NDC: 58160-0903-52,

MFG: GLAXO SMITH KLINE, KSH/KSH/KSH/ /KSH. PACKAGE INSERT
GRN 600
INTUITIVE RECS
NDA 020468
HOSPIRA, MCPHERSON, KS - WARNING LETTER MEETING RECS 02/14/2017

ORPHAN DRUG DESIGNATION REQUEST BY BLUEBIRD BIO FOR A CAR T-
CELL THERAPY PRODUCT, NOVARTIS FOR CAR T-CELL THERAPY PRODUCT
BREAKTHROUGHG THERAPY DESIGNATION REQUEST BY BLUEBIRD FOR CAR
T-CELL THERAPY PRODUCT ETC
K172111
K130623
XOLAIR AERS
CINQAIR AERS
DUPIXENT AERS
REC BETWEEN MITCH ZELLER AND ROBERT CALIFF ABOUT FDA PROPOSAL
TO LOWER NICOTINE LEVELS IN COMBUSTIBLE CIGARETTES 03/01/2016 -
01/29/2017
NUCALA AERS
PROVENGE, SIPULEUCEL-T AERS
IMURAN RECS
URBAN MOONSHINE, INC, URBAN MOONSHINE NATURAL PRODUCTS COMPANY,
LLC - RECS, CORRR RE DIETARY SUPPLEMENT PRODUCTS, 12/05/2002 -
12/06/2017
DRUG SAFETY COMMUNICATION DAYTRANA
RUMENSIN AERS
HARBINGER MEDICAL GROUP, LLC, DBA TIDES MEDICAL, LAFAYETTE, LA
- EIR 01/01/2015 - 12/06/2017
HARBINGER MEDICAL GROUP LLC, LAFAYETTE, LA - EIR 01/01/2015 -
12/06/2017
FLU SHOTS - CMPLNTS, LIST OF INGREDIENTS
MISLEADING AND DECEPTIVE PACKAGING FOR FOOD - WARNING LTRS,
LEGAL ACTIONS
PHILIP MORRIS USA - MARLBORO BLEND 27 72S BOX SE0010678
MARLBORO MIDNIGHT MENTHOL 100S BOX SE0010679 MARLBORO RESERVE
100S BOX SE0010680 SUBSTANTIAL EQUIVALENCE RPTS
PHILIP MORRIS USA - DAVE'S CHESTNUT GROVE BLEND BOX SE0013539

DAVE'S AUBRUN BLEND BOX SE0013540 DAVE'S FARMHOUSE BLEND BOX
SE0013541, ETC WITHDRAWN SUBSTANTIAL EQUIVALENCE RPTS
VECTOR TOBACCO INC - USA SILVER 100S BOX SE0009105 USA MENTHOL
100S BOX SE0009106 USA MENTHOL SILVER 100S BOX SUBSTANTIAL
EQUIVALENCE RPTS RVW MEMOS, MTG MINS, ETC
CLOSED FOI REQUESTS 11/27/17-12/1/17
FOI DIALY LOG 11/27/17-12/1/17
FOI DIALY LOG 11/27/17-12/1/17
FOI DIALY LOG 11/27/17-12/1/17
FOI DIALY LOG 11/27/17-12/1/17
FOI DIALY LOG 11/27/17-12/1/17
FOI DIALY LOG 11/27/17-12/1/17
FOI DIALY LOG 11/27/17-12/1/17

GLAXO SMITH KLINE - CHLORPROMAZINE HCL ANDA 9-149 UPSHER-SMITH
LABORATORIES LLC - CHLORPROMAZINE HCL ANDA 84-112, ANDA 84-114,
ETC SBA
INDIVIDUAL RECS
INDIVIDUAL RECS
ENT, MENLO PARK, CA - EIR, 483 10/30/17-11/3/17
TREU-INSTRUMENTE GMBH, NEUHAUSEN, GERMANY EIR 6/29/15-7/2/15

K072899 K122011
GLATOPA, GLATIRAMER ACETATE, COPAXONE - AERS
FCN 675, 704, 983, ETC
Opdivo BLA 125554/S-022: SCCHN Opdivo BLA 125554/S-019: Hodgkin
Lymphoma Opdivo BLA 125554/S-012: ETC
Letter sent by FDA to manufacturers of agglomerated cork
stoppers
INDIVIDUAL RECS
GLATOPA, GLATIRAMER ACETATE, COPAXONE AERS
BERINERT AERS
MSD/ORGANON, NETHERLANDS - EIR 01/01/2014 - 12/31/2014
K122558
SOMATICS LLC THYMATRON ECT EFFICACY AND SAFETY OF ECT FIRST
PARTY K945120 01/01/1997 - 12/30/1997 K945120
REPRO-MED SYSTEMS INC, CHESTER, NY - EIR ATTACHMENTS 10/02/2017
- 10/19/2017
NDA 20733/S-020
REPRO-MED SYSTEMS INC, CHESTER, NY - EIR ATTACHMENTS 06/03/2015
- 12/17/2016
K011369
K141752
ANDA 203133
ANDA 209359
K172856
K060743
K171392
MANUALS, MODULES, GUIDANCE TRAINING FOR INTERSTATE TRAVEL
PROGRAM
BELSOMRA MEDWATCH RECS
Supplement approval letter for ANDA 064144 / S-005 Mitomycin
for Injection
13763148 13672510 13663839 ETC
RECS RE AKORN 01/01/2017 - 12/07/2017
Medwatch reports for Zepatier
BAXTER PHARMACEUTICAL SOLUTIONS, LLC, BLOOMINGTON, IN - EIR,
483
ANDA 203386 APPROVAL LETTER
K162812
Medwatch Reports for Keytruda (pembrolizumab)
Please forward the 2017 (FDA) Federal Employee Viewpoint Survey
results - 3rd level and/or specific to the Office of Criminal
Investigations
FAP 2017-15535, 2014-18969, 2016-16738
AMA LABORATORIES INC - RECS RE FDA RAIDS 04/01/2017 -
04/30/2017
MEDWATCH REC
PURCHASE CARD HOLDER LIST 01/01/2017 - 12/08/2017
VVV & SONS EDIBLE OIL LIMITED, INDIA - SESAME OIL RECS
CARDIOCOMMAND INC, TAMPA, FL BOTON MEDICAL, SUNRISE, FL
BOLTON MEDICAL - 483 02/09/2012 - 05/17/2017
MedWatch Case 13546682 (Grastek)
BAXTER HEALTHCCARE CORPORATION, ROUND LAKE, IL - EIR
02/27/2017 - 03/08/2017
FDA COMMUNICATIONS WITH LAMB WESTON OR SYSCO RE RECALL OF GREEN
CHILE PRODUCT ETC 03/01/2017 - 12/07/2017
ANIDRO, BRAZIL EIR 12/02/2016 - 12/07/2017
GUANGDONG BAIHE MEDICAL TECHNOLOGY CO LTD, CHINA - 483
PFIZER-HOSPIRA, MCPHERSON, KS - 483, EIR, CLOSEOUT LETTER
10/01/2017 - 12/07/2017
GENZYME, LYNNWOOD, WA - 483 03/25/2008 - 08/17/2017 PHILIPS
ULTRASOUND INC, BOTHELL, WA - 483 PHILIPS ELECTRONICS NORTH
AMERICA CORP, BOTHELL, WA - 483
RECS RE KRATOM DEATHS
TOBACCO USER FEE RECS
INTERVIEW RECS
NDA 017794 ANDA 078826, 077396, 078203, ETC
MedWatch Reports for Janumet
INDIVIDUAL RECS
MedWatch reports for Januvia
INTUITIVE SURGICAL INC - OPERATIVE RPT
ADMIRAL FISH FARMS - E COLI CONTAMINATION INVESTIGATION 6/13

ATRIUM MEDICAL CORP, MAQUET CARDIOVASCULAR US SALES LLC,
GETINGE AB - HERNIA MESH PRODUCTS 30900 PROLOOP W/ONLAY, 30908
PROLOOP W/KEYHOLE SLIT ONLAY, ETC 510K SUBMISSIONS
CR BARD INC, DAVOL INC - HERNIA MESH PRODUCTS 0112750 SMALL
PERFIX PLUG, 0112760 MEDIUM PERFIX PLUG, 01222770 LARGE PERFIX
PLUG, ETC 510K SUBMISSIONS
2017-506, 2017-404, 2017-501
NO BONES (OR BONE TREATS) ABOUT IT: REASONS NOT TO GIVE YOUR
DOG BONES - FDA WARNING 11/21/17
INDIVIDUAL RECS - AERS
JOHN C HORTON, LEGITSCRIPT LLC - CONTRACT HHSF223201000071C
ESTEVE QUIMICA, SA - CELRA, SPAIN - 483, EIR, RESPONSE
01/04/2015 - 12/07/2017
DOTTIKON, SWITZERLAND, FARMISPANIA, BARCELONA, SPAIN, BEND
RESEARCH, INC, BEND, OR - EIR, 483, RESPONSE 01/01/2016 -
12/07/2017
LETTER FROM MARTEK TO FDA - DATE AVAILABLE TO PUBLIC ETC
02/01/2000 - 06/20/2002
GSCM VENTURES, INC WARNING LETTER 12/08/2006 - 12/15/2006
EI LLC, PRODUCT QUEST, ENDEV LABORATORIES, KANNAPOLIS, NC - 483
09/01/2017 - 12/08/2017
CHAD V RICE, BARK TO BASICS, OLATHE, KS - EIR 03/20/2017 -
03/22/2017
FCN 178
TARGET ACTION DATES AND GDUFA DATES ETC 11/01/2016 - 11/30/2017

HAND BIOMECHANICS LAB, INC, SACRAMENTO, CA - EIR, 483, CORR
06/22/2017 - 07/05/2017
12/12/2017
K172884
WUXI FORTUNE PHARMACEUTICAL CO LTD, CHINA - 483 7/28/17
Methylergonovine Maleate DESI review (National Academy of
Sciences)
LUPIN, MAHARGSHTRA, INDIA - EIR MOST RECENT
ACETELLION UPTRAVI ORPHAN DRUG DESIGNATION SUBMISSION
03/06/2014 - 12/08/2017
NUPLAZID 13977706 13253365 14032516 ETC
CPT1600663
Technical Project Lead Reports and decision summaries to the

Substantial Equivalence (SE) Orders issued in September 2017
FCN 178, 475, 963
PHIBRO ANIMAL HEALTH CORPORATION, CHILLICOTHE, IL - EIR
09/18/2017 - 09/22/2017
FCN 118
ENTRY NO DPA4-8170724-9
SYNVINC-1 IMPRUVICA - AER
214822, 216683, 214986, ETC - MEDWATCH
SORBIC ACID, SUCCINIC ACID, SODIUM BENZOATE, POTASSIUM SORBATE
- RECS
TRAMADOL - AER
ATRIUM MEDICAL CORP - 30900 PROLOOP W/ONLAY, ETC 510K
CR BARD - SMALL PERFIX PLUG, ETC 510K
SOUTHERN STATES COOPERATIVE, KY GARGILL, IA PITMAN FAMILY
FARMS, CA - PHOTOGRAPHS TAKEN BY INSPECTIONAL PERSONNEL
01/01/2017 - 12/08/2017
DIASEPAM VISCOUS SOLUTION ORPHAN DRUG DESIGNATION RECS
02/25/1991 - 03/31/1992
Import Alert 66-38, Import Alert 66-41 RECS
DOSE RANGING AND PHASE 3 EFFICACY/SAFETY DATA IMURAN
TEND SKIN INTERNATIONAL, DAVIE, FL - EIR 01/09/2001 -
07/30/2010
twenty three (23) Exemption from Substantial Equivalence Final
Orders issued in September 2017
RECS RE COMPLAINT 150526, DEVICE RECS
HAEGARDA AERS
PETER O'DONNELL, MD, UNIVERSITY OF CHICAGO MEDICAL CENTER,
CHICAGO, IL - 483, RESPONSES 12/01/2016 - 02/28/2017
CELLTRION, INC, INCHEON, KOREA - 483 CORR 05/01/2017 -
12/11/2017
EIR INFORMATION
NDA 017871
three (3) Exemption from Substantial Equivalence Final Orders
issued in October 2017
VOX NUTRITION INC, JORDAN, UT NUTRITION FORMULATORS INC,
MIRAMAR, FL - 483, WARNING LETTER 01/01/2007 - 12/11/2017
INTERSECT ENT, MENLO PARK, CA - 483 09/01/2017 - 12/31/2017
HHSF22301001T under HHSF223200850014I
Keytruda BLA 125514/S-16
LISTING OF INSPECTIONS 11/01/2017 - 11/30/2017
one (1) Not Substantially Equivalent (NSE) Order issued in
October 2017
K163484
eleven (11) Substantial Equivalence (SE) Orders issued in
October 2017
K121064
NDA 021187/S-034
GRUNDY COUNTY, TN - OPIOID DISTRIBUTION SINCE 2012
SIQUATCHIE COUNTY, TN - OPIOID DISTRIBUTION SINCE 2012
MURRAY COUNTY, TN - OPIOID DISTRIBUTION SINCE 2012
CHATTOOGA COUNTY, GA - OPOID DISTRIBUTION SINCE 2012
FRANKLIN COUNTY, TN - OPIOID DISTRIBUTION SINCE 2012
JACKSON COUNTY, AL - OPIOID DISTRIBUTION SINCE 2012
BLEDSOE COUNTY, TN - OPIOID DISTRIBUTION SINCE 2012
DEKALB COUNTY, AL - OPIOID DISTRIBUTION SICE 2012
DADE COUNTY, GA - OPIOID DISTRIBUTION SINCE 2012
FULTON COUNTY, GA - OPIOID DISTRIBUTION SINCE 2012
WALKER COUNTY, GA - OPIOID DISTRIBUTION SINCE 2012
WHITFIELD COUNTY, GA - OPIOID DISTRIBUTION SINCE 2012
MARION COUNTY, TN - OPIOID DISTRIBUTION SINCE 2012
CATOOSA COUNTY, GA - OPIOID DISTRIBUTION SINCE 2012
ULTRA SEAL, NEW PALTZ, NY - EIR 11/5-12/14
NICOTINE, FLUTICASONE PROPIONATE - AER
VAERS 711147
ABBOTTS, SYLMAR, CA - EIR, RESP, 483, WARNING LTR 2/17
XARELTO RECS CERTIFIED
METAGENICS - INVESTIGATION RECS, RESPONSES ETC 03/16/2017 -
12/11/2017
DR REDDY RESPONSE TO 493 FOLLOWING NOV 15 WL 11/01/2014 -
12/12/2017
CORR BETWEEN FDA AND EPIC RESEARCH & DIAGNOSTICS RESEARCH INC
RE CLASSIFICATION 01/01/2015 - 12/11/2017
COATING PLACE, INC, VERONA, WI - EIR 02/01/2016 - 04/01/2016

BIOWELL 513(G) RECS 03/01/2017 - 12/12/2017
AKORN PHARMACEUTICALS - 483, ANDA, SUBPOENA 10/19/2017 -
12/12/2017
THRESHOLD OF REGULATION EXEMPTION 2016-002
K152086
CPT#1701355
SPAULDING CLINICAL RESEARCH, LLC, WEST BEND, WI - 483
03/01/2017 - 03/31/2017
PROTON PUMP INHIBITORS - AERS
HEALTH BIOTECH LTD, PUNJAB, INDIA - EIR, 483 2014-2017
SUGAR DADDY LTD, UNITED FRUIT AND PRODUCE CO, BIDART BROS -
LISTERIA OUTBREAK CORR, INVESTIGATIONS 2014-2015
LIVANOVA STOCKERT 3T HEATER-COOLER SYS - MDRS 1/1/16,

NONTUBERCULOUS MYCOBACTERIA INFECTIONS, INDIVIDUAL RECS, ETC
FORMPACK BLISTER MATERIALS SECTION 4.1 DMF15067 - SUBMISSIONS

2017-10118
KLS MARTIN LP - INDIVIDUAL PATIENT SOLUTIONS PLATE K163579
DURAGESIC (FENTANYL) - INITIAL FDA-APPROVED LABEL, WARNING
LTRS, UNTITILED LTRS
YAEL GLAZER - ENTRY NUMBER 9WH10156412 NOTICES FOR REQUEST OF
IINFORMATION (CF28) FDA NOTICE OF ACTION, CBP REDELIVER
NOTICES (CF4647)
FOIA DAILY LOG 2017
RECS RE IMPORTATION OF INJECTION DRUGS IN IDAHO
OTC Volume 060171
ANDA 60014
BIOCON LIMITED EIR
VIAGRA AERS
2003-10105
2003-10115
VITAMIN CORPOPRATION MIRA LOMA, CA - EIR, 483 12/31/2016 -
12/13/2017
Oncologic Drugs Advisory Committee (ODAC) Meeting transcript
for the December 13th, 1994 ODAC meeting
NIVOLUMAB, IPILIMUMAB ORPHAN DESIGNATION RECS
FDA-20005-D-0455
Current approved labeling for Robinul NDA 017558
K072094
2003-10151
2003-10828
RECS RE FOLIC ACID AS A FOOD ADDITIVE IN CORN MASA FLOUR
2003-10148
FDA BAD AD RECS 05/01/2010 - 12/01/2017
HEATER COOLER DEVICES ADVERSE EVENTS 05/01/2015 - 12/13/2017

2003-10986
2003-10821
NDA 012750 SBA
RECS RE CHARACTERIZATION OF BENEFICIAL EFFECTS FROM FISH
CONSUMPTION DURING PREGNANCY IN 2015-2020 DIETARY GUIDELINES
FOR AMERICANS 01/01/2015 - 01/01/2016
IMS TRADING CORP, IMS PET INDUSTRIES, CHINA - CORR, TESTING,
ETC 01/01/2008 - 12/31/2014
DOLE SPRINGFIELD, OH - INSPECTION RECS 01/01/2015 - 12/14/2017

SATO PHARMACEUTICAL CO, LTD, JAPAN - 483 02/08/2016 -
02/12/2016
X12 CO LTD, BULGARIA - 483 09/05/2016 - 09/07/2016
NDA 019732 SBA

MIMEDX CORR WITH FDA RE EPIFIX, AMNIOFIX 11/01/2017 -
12/14/2017
ANDA 208011
CELLEX-C INTERNATIONAL INC, CANADA - 483 01/16/2017 -
01/19/2017
FOSHAN FLYING MEDICAL PRODUCTS CO, LTD, CHINA - 483 02/20/2017
- 02/23/2017
ALAN BARKER, MD, PORTLAND, OR - EIR, 483, CORR 05/22/2017 -
05/31/2017
HASSAN YAISH, SALT LAKE CITY, UT - EIR, 483, CORR 06/26/2017 -
06/30/2017
3M COMPANY, BROOKINGS, SD - EIR, 483, CORR 5/21/15
BAXTER INTERNATIONAL, ROUND LAKE, IL - EIR, 483, CORR 7/29/13

COMMUNICATIONS BETWEEN FDA AND SANOFI AVENTIS RE UNTITLED
LETTER NDA 206538 12/13/2016 - 12/12/2017
RECS RE MEETING OCC AND DIETARY SUPPLEMENT INDUSTRY 08/15/2017
- 12/14/2017
RECS RE MEETING CFSAN OFFICE OF DIETARY SUPPLEMENT PROGRAMS AND
DIETARY SUPPLEMENT INDUSTRY 08/15/2017 - 12/14/2017
K161582
FCN 773
IPSEN BIOSCIENCES, CAMBRIDGE, MA - EIR, 483, RESPONSE 7/17/15

CANGENE BIOPHARMA DBA EMERGENT BIOSOLUTIONS, BALTIMORE, MD -
EIR, 483, RESPONSE 12/20/16
CHARLES RIVER LABORATORIES, WOBURN, MA - EIR, 483, RESPONSE
12/6/16
GRIFOLS BIOLOGICALS, LOS ANGELES, CA - EIR, 483, RESPONSE
10/20/15
MAYNE PHARMA GREENVILLE, NC - EIR, 483, RESPONSE 5/11/12
PATHOLOGY ASSOCIATES MEDICAL LABORATORIES, SPOKANE, WA - EIR,
483, RESPONSE 10/16/12
REGENERON PHARMACEUTICALS, RENSSELAER, NY - EIR, 483, RESPONSE
6/13/14
TEVA PHARMACEUTICALS, HORSHAM, PA - EIR, 483, RESPONSE 1/30/13

UCSF MEDICAL CENTER CLINICAL LABORATORIES, BLOOD CENTER, SAN
FRANCISCO, CA - EIR, 483, RESPONSE 6/12/15
COOK PHARMICA, BLOOMINGTON, IN - EIR, 483, RESPONSE 5/19/17

HUBIE DANJIANGKOU DANO PHARMACEUTICAL CO LTD, CHINA - 483
07/31/2017 - 08/04/2017
DRUG APPROVAL LETTERS 01/01/2000 - 12/01/2017
MP BIOMEDICALS, BURLINGAME, CA- EIR, 483, RESPONSE 3/2/15
FCN 697
FCN 535
ROBERT D WILSLOW, MD, DANBURY, CT - EIR, 483, RESPONSE 5/26/16

GC HANFORD MANUFACTING COMPANY, SYRACUSE, NY - EIR MOST RECENT
12/01/2015 - 12/14/2017
GENERAL MEDICAL COMPANY, OJAI, CA - EIR, 483, RESPONSE
10/30/15
AMAZON.COM KYDC, LLC, LEXINGTON, KY - INSPECTION RECS
01/01/2017 - 12/14/2017
MEDSCIENCES, DELRAY BEACH, FL - EIR, 483, RESPONSE 3/29/16
BIOEQUIVALENCE REVIEWS HIKMA ANDA 065350
NDA 020281
DYNAREX CORPORATION, ORANGEBURG, NY - EIR, 483, RESPONSE
3/2/17
CATACHEM, INC, OXFORD, CT - EIR 09/10/2012 - 09/18/2012
VITACOLOR, WESTMONT, IL - EIR, 483, RESPONSE 1/11/17
ALLISON MEDICAL, LITTTLETON, CO - EIR, 483, RESPONSE 10/12/16

NDI 140, NDI 141, NDI 130
ACTAVIS LABORATORIES UT, SALT LAKE CITY, UT - EIR, 483,
RESPONSE 10/17/14
ETHICON, CORNELIA, GA - EIR, 483, RESPONSE 8/30/13
SAMSUNG SDI AMERICA INC, SAMSUNG SDI CO LTD, SAMSUNG
ELECTRONICS CO LTD, ETC - LITHIUM ION BATTERIES, RISK OF
EXPLOSION, DANGERS OF E CIGARETTES, ETC
SILVER - AERS 2003 TO 2017
3S-PHARMACOLOGOCAL CONSULTATION, BUCHAREST, ROMANIA AIT
BIOSCIENCE, INDIANAPOLIS, IN ALLIANCE PHARMA INC, MALVERN, PA,
ETC - 483S 2013 TO 2016
IN VIVO BIOEQUV, GOOD LABORATORY PRACTICE, IRBS, ETC - 483S
2015, 2016
PULSED ENERGY TECHNOLOGIES - ENERGY PULSER MODEL PER 2000 JR
APRVL RECS
GE HEALTHCARE - MYOVIEW (TECHNETIUM TC-99M TETROFOSMIN KIT) NDA
20-372 APPLICATION, SUPPLEMENTAL APPLICATION
STRAUMANN CO - STRAUMANN EMDOGAIN P30021SS&E, APRVL ORDER LTR,
LBLG, ETC
COPPER RIVER SEAFOOD - VIOLATIONS, CMPLNTS LAST 10 YRS
K153645
RECS RE ESTIMATES OF ANTIMICROBIAL ANIMAL DRUG SALES INTENDED
FOR USE IN DOMESTIC AQUACULTURE 2009-2016
9516682, 11892999, 9236687, ETC
FOIA DAILY LOG 10/14/2017 - 12/15/2017
CBER CORR TO MIMEDX RE AMNIOFIX 12/01/2014 - 12/15/2017
ARROW RELIANCE INC, TUKWILA, WA - 483 01/01/2016 - 12/15/2017

K081459
CONTACT COATING INC, HACKENSACK, NJ - EIR 12/04/2015 -
12/15/2017
SIMILASAN CORP - INVESTIGATIONS, INSPECTIONS RECS 01/01/2000 -
12/15/2017
AESCULAP IMPLANT SYSTEM BIMO INSPECTION, CENTER VALLEY, PA -
EIR, CLOSEOUT LETTER 02/01/2013 - 12/31/2014
K161882 D
RECS RE CC 149309
AESCULAP, INC, HAZELWOOD, MO - EIR, CLOSEOUT LETTER 07/01/2010
- 12/31/2011
OGD SUBSET OF SUBJECTS FROM ENTIRE POPULATION IN PROTOCOL
DATASET FOR BIOEQUIVALENCE TO REFERENCE LISTED DRUG
JOINN LABORATORIES CO LTD, CHINA - 483 01/01/2009 - 12/16/2017

RTI SURGICAL, INC, ALACHUA, FL - 483, CORR 04/01/2017 -
12/31/2017
CONCERN RE NON ORGANIC VEGETABLES
K141668
RECS RELEASED UNDER FOIA SIMILASAN AG 01/01/2000 - 12/15/2017

INDIVIDUAL RECS
K091734
NDA 019057
K073482
K143538
K023183
K934086
NDA 019668
K042784
K903390
K171022
All harmful and potentially harmful constituent reports made by
Philip Morris USA Inc. or related entities to the Food and Drug
Administration with respect to cigarettes
COMPOUNDING PHARMACY INSPECTION RECS 03/01/2015 - 05/11/2017

Methyldopate SBA
K121593
K121484
PRASTERONE FDA REPORT
INTRATHECAL COMPOUNDING SPECIALISTS LLC - INSP 11/17
COFFEY COUNTY LAKE SAMPLES 2017
ENVIRONMENTAL SAMPLES 1/17 TO PRESENT
RDI/RDA
NDA 50-718/S-10 50-718/S-29
MAURICIO BARRERA - TUNA CONTAMINATION AT TORTUGAS MEXICAN
KITCHEN, GALVESTON, TX
CORR BETWEEN FDA & TAULER SMITH REGARDING ENHANCED ATHLETE INC
1/17 TO PRESENT
2017-9594
VAERS RPT SUBMITTED ON 12/13/17 FOR DOB 2/20/56
PHARMACY COMPOUNDING INSPECTION RECS 02/18/2014 - 10/27/2017

ORANGE BOOK 01/01/2011 - 01/01/2016
CAP 2C0294 5C0302
sNDA 204629/S-008 SBA
CAP 7C0283
K161285
P820083, S023, GORE-TEX Suture
All FDA Center for Tobacco Products' reviewer's guides for the
review of PMTAs, including ENDs PMTAs
RECS RE MEETINGS FDA RE GMP, TOBACCO PRODUCT MANUFACTURING
PRACTICES
PURCHASE CARD HOLDER LIST
FSVP IMPORTERS SPREADSHEET 11/01/2017 - 11/30/2017
ZHEJIANG HISUN PHARMACEUTICAL CO LTD, CHINA - 483 08/04/2017 -
12/19/2017
ZHEJIANG HISUN PHARMACEUTICAL CO LTD, CHINA - 483 08/01/2017 -
12/19/2017
RANDALL STOLZ, EVANSVILLE, IN - EIR
CHEYENNE INTERNATIONAL, GROVER, NC NASCO PRODUCTS, MOCKSVILLE,
NC RJ REYNOLDS, TOBACCOVILLE, NC - EIR
SHERMAN'S, GREESNBORO, NC, SANTA FE NATURAL TOBACCO, OXFORD, NC
- EIR
K032677
LIST OF COMPANIES IN VIOLATION OF FSVP 01/01/2017 - 12/19/2017

ENDO PHARMACEUTICALS LIDODERM, OPANA ER FORM 2253 RECS
KRETEK, MOORPARK, CA - EIR ETC
483s issued by the CDER International Operations Operations
Office -- Complex Queue
DOMESTIC TOBACCO, LANCASTER, PA - EIR ETC 12/02/2015attached.

NDA 20-560
WINTAC LTD, BANGALORE, INDIA - 483 04/01/2017 - 12/19/2017
BETTY LOU'S, INC, MCMINNIVILLE, OR - EIR 12/04/2015 -
12/19/2017
FOIA LG ABBOTT, ABBOTT LABS, ABBOTT LABORATORIES 11/01/2017 -
11/30/2017
CADILA - 483 01/01/2014 - 12/31/2014
Drug Master File 29641
K171230, K163099, K141929
COGENT LAW GROUP, COVIDIEN LTD, MEDTRONIC - PARIETEX K982532
CORR 1/198 TO PRESENT
CORR BETWEEN CR BARD K922916 INC AND FDA BETWEEN 1/92 TO
PRESENT
CORR BETWEEN ETHICON INC K915774 & FDA BETWEEN 1/91 TO PRESENT
CORR BETWEEN ETHICON INC K984220 & FDA BETWEEN 1/98 TO PRESENT
EIGHT HOUR FACTOR ANALYSIS REGARDING FENFLURAMINE UNDER CSA
RECS RE EMA PHARMACOVIGILANCE RISK ASSESSMENT COMMITTEE REPORT
SILDENAFIL
SCHAPER & BRUMMER - EIR, 483 01/01/2015 - 12/20/2017
ANDA 208518 EFFECTIVE APPROVAL LETTER
MIDWEST VETERINARY SERVICES, OAKLAND, NE - 483, 482, ETC
07/01/2015 - 12/15/2017
nine (9) Not Substantially Equivalent (NSE) Order issued in
November 2017
11/01/2017 - 11/30/2017 483 Issued by Atlanta DO
CDRH 483 11/01/2017 - 11/30/2017
CHICAGO 483 11/01/2017 - 11/30/2017
DALLAS 483 11/01/2017 - 11/30/2017
DENVER 483 11/01/2017 - 11/30/2017
DETROIT 483 11/01/2017 - 11/30/2017
FLORIDA 483 11/01/2017 - 11/30/2017
K053175
KANSAS 483 11/01/2017 - 11/30/2017
LOS ANGELES DO 483 11/01/2017 - 11/30/2017
MINNEAPOLIS DO 483 11/01/2017 - 11/30/2017
NEW ENGLAND DO 483 11/01/2017 - 11/30/2017
NEW JERSEY DO 483 11/01/2017 - 11/30/2017
NEW YORK DO 483 11/01/2017 - 11/30/2017
PHILADELPHIA DO 483 11/01/2017 - 11/30/2017
SAN FRANCISCO DO 483 11/01/2017 - 11/30/2017
SEATTLE DO 483 11/01/2017 - 11/30/2017
CDER SIMPLE QUEUE 483 11/01/2017 - 11/30/2017
K083597 K112469 K992304
K030573
NDA 16087 LABELING
ZIMMER BIOMET, WARSAW, IN - 483, CORR 10/01/2017 - 12/31/2017

INDIVIDUAL RECS
SBA ANDA 020578 NDA 019726
FDA-2015-P-2676 FDA-2014-P-1400
ten (10) Substantial Equivalence (SE) Orders issued in November
2017
CROWN SEVEN - LITHIUM ION BATTERIES, E-CIGARETTES RISK OF
EXPLOSION, MEMOS, STUDIES, RESEARCH PAPERS, ETC
LG CHEMICAL AMERICA INC, LG CHEM LTD, LG CHEM MICHIGAN INC, ETC
- LITHIUM ION BATTERIES, E-CIGARETTES RISK OF EXPLOSION, MEMOS,
STUDIES, RESEARCH PAPERS, ETC
DANIEL FABRICANT - RECS 10/30/12 TO 8/18/17
DOG BONE TREATS - INJURY RPTS
EMAILS SENT TO OR FROM DANIEL FABRICANT BY CHROMADEX OR ITS
FOUNDER FRANK JAKSCH
2003-11109
2003-15521
2003-11047
200311698
2003-13449
2003-13805
2003-15180
2003-15192
2003-14519
2003-14320
2017-9859
2017-9961
2015-4334
2017-7352
2017-9552
2017-8501
seven (7) Exemption from Substantial Equivalence Final Orders
issued in November 2017
K980548
CENTRAL STATES RESEARCH CENTRE, OAKLAND, NE 482, 483, EIR
06/01/2015 - 12/15/2017
SLEEP STUDIES INSPIRE SLEEP THERAPY
FDA-2015-P-2676 FDA-2011-P-0064 FDA-2011-P-0072 FDA-2011-P-0077
PIRAMEL PHARMA SOLUTIONS INC, LEXINGTON, KY - EIR, 483
08/15/2016 - 08/19/2016
STERIGENICS WILLOWBROOK, IL - EIR ange: 02/04/2015 - 02/28/2015

COMPLAINT 46766
DON LEE FARMS, MANSFIELD, TX - EIR, TESTING RESULTS, RECALLS
ETC 01/01/2010 - 12/22/2017
INNOSPEC ACTIVE CHEMICALS, SALISBURY, NC EIR 08/01/2015 -
09/30/2016
ZIMMER BIOMET PROGRESS UPDATE, FDA RESPONSE, SCHEDULE OF FUTURE
INSPECTIONS 08/01/2017 - 12/20/2017
ARTERIOCYTE DBA COMPASS BIOMEDICAL, HOPKINTON, MA - INSPECTION
RECS 10/27/2017 - 11/10/2017
RECS RE PRE-CONSULTATION OR SUBMITTED MATERIALS RE FOOD
ADDITIVE PETITIONS FOR TRANS FATS, AMENDMENTS ETC
AMAZON.COM KYDC, LLC, LEXINGTON, KY - 483 05/01/2010 -
06/20/2010
COSMETIC SOLUTIONS, BOCA RATON, FL - EIR, 483
K132306
K123487
K151929
RECS RE HUMAN FOOD SAFETY INFORMATION OR ANALYSIS FROM 4/6/87

NDI 999
DEN170022
CMPLNT 149978
REP ED ROYCE - CONGRESSIONAL CORR
RADIANCY INC, ORANGEBERG, NY - EIR 2/22/12-3/1/12

LUPANETA PACK NDA 203-696 - RECS
SATEK USA LLC - NEW DIETARY INGREDIENT NOTIFICATION 6/24/16
RECS RE RIFE DEVICES 01/01/1925 - 12/31/1971
AJANTA PHARMA LIMITED, ROCHE DIAGNOSTICS, GERMANY - EIR, 483
01/01/2015 - 09/20/2017
MGP INGREDIENTS INC, INDIA - RECS RE GRANTS, CONTRACTS
09/04/2012 - 09/22/2017
MARITIME AQUARIUM OF NORWALK INSPECTION RECS, REPORTS
09/01/1995 - 09/01/2017
WALMART, COVINGTON, LA - WARNING LETTER, CIVIL MONEY PENALTY
LETTER 07/14/2017 - 09/25/2017
2017-2231
2017-4278
2017-4575
2017-6043
2017-6065
2017-6072
2017-6139
2017-7012
2017-6164
2017-6283
2017-6791
2017-7183
2017-6856
2017-6968
2017-7313
COMMISSIONER VISITOR LOGS
COMMISSIONER CALENDAR
FOIA LOG
MEDWATCH REPORTS EPIPEN, EPIPEN JR
PEGASUS LABORATOARIES, PENSACOLA, AL - EIR 12/22/2016
IMPORT REFUSAL DATA
INVACARE CORPORATION, GERMANY - 483 05/01/2017 - 09/25/2017

INVACARE WARNING LETTER 05/01/2017 - 09/26/2017
SANOFI PASTEUR - TYPHOID VI POLYSACCHARIDE VACCINE RECALL RECS,
CORR
K100442
DEPUY ATTUNE KNEE DEVICE APPROVAL RECS
CORR WITH NEAL P DUNN 01/01/2017 - 09/26/2017
INFANT FORMULA SERVICES, BROOKLYN, NY - EIR
ANDA RECS
PFIZER INC, WYETH PHARMACEUTICALS INC - PROTONIX AERS, APRVL
RECS, LAB RESULTS, ETC
Foreign Food Canning Establishment numbers (FCE) filed by
Nestle trademark holders Low-Acid Canned Food, Schedule
Identifier Numbers (SID) filed by Nestle trademark holders
SUNOPTA RECALL RECS
INDIZIOR REQUEST FOR MEETING WITH OCC, CDER 06/01/2017 -
09/26/2017
LIFETIME TOXICITY/CARCINOGENICITY STUDIES FD&C BLUE NO 1 IN
RATS AND MICE ETC 09/25/1972 - 10/31/1981
GVK BIOSCIENCES, HYDERABAD, INDIA - INSPECTION RECS MOST RECENT

GP PHARM, SPAIN - INSPECTION RECS 01/01/2015 - 09/27/2015
CHARLES WHITE - CERTIFICATION OF INVESTIGATION, SF75
LIGGETT BRANDS NSE ORDERS
TECHNICAL PROJECT LEAD REPORTS NSE ORDER LIGGETT BRANDS
BERGSTROM NUTRTION, VANCOUVER, WA BULK APOTHECARY, AURORA, OH
- INSPECTION RECS 09/27/2015 - 09/27/2017
ARMONAIR RESPICLICK AERS
AUSTEDO AERS
PRO AIR RESPICLICK AERS
FAERS 12904567 12965126 13097723 ETC
All review memoranda for food contact notifications 438 and 373
CHARLES RIVER LAB RENO, NV - 483, EIR 12/01/2016 - 01/31/2017

INDIVIDUAL RECS
RECS RE OXYCONTIN ADVERTISEMENTS
INGREZZA AERS
Summary Basis of Approval (SBOA) for Mephyton (phytonadione)
Tablets, 5 mg
K992621
K911296
ZECUITY AERS
OFFICE OF THE COMMISSIONER, ASSOCIATE COMMISSIONER FOR EXTERNAL
AFFAIRS - CORR, MEMOS REGARDING REQUESTS FROM MEMBERS OF THE
MEDIA 1/20/17-9/28/17
AUSTEDO AERS
CMPLNT
TEVA PHARMS - EPINEPHRINE AUTO INJECTOR SANOFI - AUVI-Q
EPINEPHRINE AUTO INJECTOR SEN JOE MANCHIN CORR, MTGS, CALENDAR
ENTRIES, ETC 1/1/15 TO 1/1/17
ON-X LIFE TECHNOLOGIES INC - PROSPECTIVE RANDOMIZED ON-X
ANTICOAGULATION CLNCL TRIAL POST APRVL STUDIES
CINCINNATI SUB-ZERO - INFORMATION ABOUT THE USE OF FORCED AIR

THERMAL REGULATING SYSTEMS-LETTER TO HEALTH CARE PROVIDERS
3M - INFORMATION ABOUT THE USE OF FORCED AIR THERMAL
REGULATING SYSTEMS-LETTER TO HEALTH CARE PROVIDERS
MEDICAL DVC RPTS, INFORMATION ABOUT THE USE OF FORCED AIR
THERMAL REGULATING SYSTEMS-LETTER TO HEALTH CARE PROVIDERS
CYMBALTA (DULOXETINE) - OFF-LABEL USES, AERS
INTERVET INC - ORBENIN DC NADA 55-069
GOLDEN CORRAL, CLINTON, MI - INSPS, CORR, FOOD TESTING, ETC
DEREN HUANG MD PHD, AKRON, OH 8/4/16 JERRY R MENDELL MD,
COLUMBUS, OH 8/19/16 SAMIR ARORA MD, GROVE CITY, OH 2/17/17,
ETC - 483S
FDA EVALUATION OF STATE OF CONNECTICUT SHELLFISH PROGRAM
01/01/2017 - 09/17/2017
FDA-1996-E-0293 FDA-1997-E-0123 FDA-2001-E-0443 FDA-1995-E-
0137
SE0003672 SE0003675 SE0003676ETC
ELORAC, INC, VERNON HILLS, IL - EIR 12/15/2014 - 09/26/2017
INSPECTION DATA
483S PREVIOUSLY RELEASED 09/01/2017 - 09/30/2017
EIRS PREVIOUSLY RELEASED UNDER FOIA 09/01/2017 - 09/30/2017
K133443
CANTON LABORATORIES PTV LTD, INDIA - PROFILE, 483, EIR SUMMARY
01/01/2012 - 09/30/2017
COMPLAINTS RE CHEERIOS AND GLUTEN FREE CLAIMS
PUBLIC HEALTH FOCUS FDA AND MARIJUANA: QUESTIONS AND ANSWERS -
RECS RE QUESTIONS 13, 14
GP PHARM, SPAIN - INSPECTION RECS 01/01/2015 - 09/27/2017
CLINICAL TRIAL RECS K113313 K033262
OCALIVA AERS
RECS RE CHANGES TO LABEL GENENTECH BLA 103792
DRUG MASTER FILE SPREADSHEET 01/01/2017 - 06/30/2017
PRINSTON PHARMACEUTICALS VALSARTAN AERS
ANDA 077747
GVK BIOSCIENCES PVT LTD GENERIC DRUGS APPROVED
ANDA 077801
List of samples tested for diclazuril between Jan 1 2014 and
September 28 2017 including sample number, sample description,
and date tested
IMARA RARE PEDIATRIC DISEASE DESIGNATION APPLICATION IMR-687

NDA 022308
K122501 FIRST PARTY
NUTRABIO, MIDDLESEX, NJ - EIR, WARNING LETTER ETC 01/01/2011 -
09/28/2017
List of samples tested for decoquinate between Jan 1 2014 and
and date tested
List of samples tested for robenidine between Jan 1 2014 and
and date tested
List of samples tested for monensin between Jan 1 2014 and
and date tested
CO TRUXTON, INC, BELLMAWR, NJ - 483 04/17/2017 - 06/01/2017
HAYWARD LABORATORIES, STROUDSBURG, PA - 483 06/28/2017 -
07/20/2017
RECS RE ZOLL LIFEVEAT WARNING LETTER 14-PHI-21
List of samples tested for clopidol between Jan 1 2014 and
and date tested
RECS RE DEN120017
List of samples tested for salinomycin between Jan 1 2014 and
and date tested
A list of all FOIA requests closed for 9/1-30/2017
K150625
List of samples tested for maduramicin between Jan 1 2014 and
and date tested
ALVIN A GABRIELSEN JR MD, LAYTON, UT 10/24/16 CORY A DUNNICK
MD, AURORA, CO 2/27/17 JEFFREY L CUTLER MD, DENVER, CO
3/13/17, ETC - 483S
List of samples tested for toltrazuril between Jan 1 2014 and
and date tested
List of samples tested for imidocarb between Jan 1 2014 and
and date tested
List of samples tested for nicarbazine between Jan 1 2014 and
and date tested
List of samples tested for lasalocid between Jan 1 2017 and
and date tested
HHSF223200950014I, HHSFDASOL08ELMS, EXETER GOVERNMENT SERVICES,
LLC-IGF:OT:IGF CVM ETC
MARTIN VALDES MD, MIAMI, FL 5/5/16 GILBERT R WEINER, MIAMI, FL

9/7/16 JOSHUA YANG MD, ORLANDO, FL 3/17/17, ETC - 483S
SE0000357SE0003683 SE0008807ETC
CLOFAZIMINE AERS
MAGELLAN DIAGNOSTICS, BILLERICA, MA - 483 05/10/2017 -
06/29/2017
ROBERT EDELMAN, GARDEN CITY, NY 6/1/16 CHAD A KILGER MD, NEW
YORK, NY 8/11/16 EDWIN P SU MD, NEW YORK, NY 12/14/16, ETC -
483S
SCOTT GOTTLIEB - CALENDAR, TRAVEL RECS 05/01/2017 - 09/28/2017

HAND BIOMECHANICS LAB, INC, SACRAMENTO, CA - 483 06/22/2017 -
07/05/2017
RESPONSE TO LETTER FROM BARBARA KOCHANOWSKI TO ELIZABETH MILLER
02/21/2014 - 11/25/2014
WILLIAM D KOLTUN MF, SAN DIEGO, CA 6/2/16 JOHN LANE MD, SAN
DIEGO, CA 7/26/16 KANG ZHANG MD PHD, LA JOLLA, CA 8/1/16, ETC
- 483S
DR REDDY'S LTD, INDIA - 483 06/12/2017 - 06/16/2017
STEPHAN A GRUPP MD PHD, PHILADELPHIA, PA 4/13/17 MARYL KREIDER
MD, PHILADELPHIA, PA 5/1/17 - 483S
RECS RE NON PUBLIC MEETINGS WITH SCOTT GOTTLIEB
List of samples tested for halofuginone between Jan 1 2014 and
and date tested
CFSAN FOIA REQUESTS 08/29/2017 - 09/28/2017
ORANGE BOOK RECS
EX0000174
PACKAGING GROUP CORP, MICHIGAN CITY, IN - 483 05/23/2017 -
06/06/2017
CORR BETWEEN OFFICE OF INFORMATION AND TECHNOLOGY MANAGEMENT RE

NASA SEWP Bid #67868, FDA Choose Your Own Device Program,Task
order HHSF223201710273W 04/30/2017 - 09/01/2017
P040033
EX0000176
CONTRACT SUPPLEMENT PACKAGING LLC, BOISE, ID - 483 06/13/2017 -
06/16/2017
ACCORD MEDIA LLC, NY, NY - 483
RECS RE PROCESS TO LIFT IMPORT ALERT DIVI'S LABORATORIS LTD
UNIT II
LOUIS FEHRENBACHER MD, VALLEJO, CA 8/11/16 DEWAN ASHEESH, LAS

VEGAS, NV 3/13/17 PAUL HARMATZ MD, OAKLAND, CA 6/16/17 - 483S
ROBERT B MONTGOMERY MD, SEATTLE, WA 11/1/16 SAAD F JAZRAWI MD,
PORTLAND, OR 3/23/17 ENEIDA R NEMECK MD, PORTLAND, OR 4/14/17,
ETC - 483S
RESPONSE TO GSK CITIZEN PETITION
EX0000175
JASON M PERRIN MD, MANNHEIM, GERMANY 3/10/17 GERRIT J BOUMA
MD, AMSTERDAM, NETHERLANDS 3/10/17 STEFAN RATH MD, DEGGENDORF,
GERMANY 3/17/17 - 483S
MEL E LUCAS DO, FLORISSANT, MO 12/12016 PIROOZ EGHTESADY MD,

ST LOUIS, MO 1/19/17 JEAN GREM, OMAHA, NE 4/5/17, ETC - 483S
DONALD L ZOGG MD, ST PAUL, MN - 483 3/1/17
EDWARD F KENT JR MD, SOUTH BURLIGTON, VT - 483 10/14/16
CHARLES JORDAN MD, LEBANON, TN 10/26/16 JITRENDA GANDHI,
MORRISTOWN, TN 6/1/17 - 483S
DAVID E HAINES MD, ROYAL OAK, MI 10/6/16 DAVID DELGADO MD,
INDIANAPOLIS, IN 11/3/16 - 483S
RAKESH PATEL, HOUSTON, TX 10/26/16 ISRAEL HARTMANN MD,
ARLINGTON, TX 10/28/16 STEPHEN E DANIELS DO, AUSTIN, TX
11/3/16, ETC - 483S
J DAVID LENTZ III MD, SNELLVILLE, GA 4/25/16 ROBERT DONALD
HARVEY, ATLANTA, GA 3/24/17 SILVA MARKOVIC-PLESE, CHAPEL HILL,
NC 6/29/17 - 483S
KIERON DUNLEAVY, BETHESDA, MD 10/3/16 PATRICIA ANN ONEAL MD,
WASHINGTON, DC 1/18/17 - 483S
STEPHEN C JENSIK, CHICAGO, IL 6/9/16 PETER O'DONNELL, CHICAGO,

IL 1/19/17 CRAIG DELLA VALLE, CHICAGO, IL 4/10/17 - 483S
SPINAL SOLUTIONS - RECS
FOI DAILY LOG 9/1-30/2017
RECS RE COMPLAINT # 140391
LIST OF FOIA REQUESTS
NERVANA STEM CELL CENTERS, SAC REGENERATIVE ORTHOPAEDICS
INSPECTION RECS 01/01/2005 - 09/29/2017
REMICADE, INFLECTRA, RENFLEXIS APPROVAL RECS
ANDA 202608
BLA 761036/Supplements 3 & 4
ANDA 208607
TRULICITY AERS
FCN 513
Transcript for 11/04/2002 Dermatologic & Ophthalmic Drugs
Advisory Committee Meeting
Reference Standard Sequence Library (RSSL) for Seafood
Identification
MEFEIR PROFESSIONAL FACIAL STEAMER - REGISTRATION, APPLICATIONS
ETC 01/01/2010 - 09/29/2017
GRAS status of menhaden oil, published in Subpart B--Listing
of Specific Substances Affirmed as GRAS
CAREPOINT HEALTHCARE LLC INSPECTION RECS 07/17/2017 -
09/25/2017
PRA HEALTH SCIENCE, LENEXA, KS - 483, EIR, CORR 04/05/2017 -
04/05/2017
FCN 1089, FCN 323
BRAUN WHEELCHAIR LIFTS COMPLAINTS, DEFECTS, ETC
FAERS 13086204, 13097723, 13651412, ETC
Operation Pangea X- LIST OF WEBSITES AND INDIVIDUALS TARGETED

AVANTOR PERFORMANCE MATERIALS, PARIS, KY - 483 10/01/2016 -
10/30/2016
BLA 103792/S5339
PMC BIOGENIX, INC, MEMPHIS, TN - 483 05/01/2014 - 05/31/2014

BIOTECHNOLOGY CONSULTATION BNF 117
PRA HEALTH SCIENCNES EARLY DEVELOPMENT SERVICES, SALT LAKE
CITY, UT - EIR, 483, 482 ETC 03/20/2017 - 03/24/2017
ZHEJIANG HUAHAI PHARMACEUTICAL, CHINA - EIR 05/15/2017 -
09/15/2017
VENETOCLAX AERS
NICLOSAMIDE SAFETY AND EFFICACY DATA
Docket No. 99N-0035
HOSPIRA, MCPHERSON, KS - INSPECTION RECS, RESPONSE 06/01/2017 -
10/03/2017
K981095, K143630, K082556, K163689
BOSTON SCIENTIFIC PRECLINICAL, ARDEN HILLS, MN - 483 09/13/2017
- 09/29/2017
ALERE, SAN DIEGO, CA - EIR 03/12/2012 - 06/27/2012
94N-0418
PMA P160030
BLA 101141, 6/11/71
NDA 009854
COPAXONE REVIEW RECS NDA 020622
SILVER SULFADIAZINE SBA
AMPHASTAR FOIA REQUESTS 10/01/2012 - 10/02/2017
ENDO PHARMACEUTICALS, PAR PHARMACEUTICALS FOIA REQUESTS
10/01/2012 - 10/02/2017
FLAMEL TECHNOLOGIES, ECLAT PHARMACEUTICALS, AVADEL
PHARMACEUTICALS - FOIA REQUESTS 10/01/2012 - 10/02/2017
IMPAX LABORATORIES, COREPHARMA, TOWER HOLDING FOIA REQUESTS
10/01/2012 - 10/02/2017
CAMBREX, HIGH POINT, NC PAULLO MILANO, ITALY CHARLES CITY, IA
ETC 10/01/2014 - 10/02/2017
Docket No. 96P-0482/CCP
ZHONGREN WU, JOANNE WANG CV
Tables of Final Conclusions (plasma donor fatalities) for FY17
NUPLAZID - AER 1/1/15 - 9/29/17
GRAS - GRN 49, 635, 436, 419, ETC
INDIVIDUAL REC
PARSEMUS FOUNDATION - VASALGEL RECS
NSPIRE OUTBREAK
CORR BETWEEN FDA & COSMETIC, TOILETRY & FRAGRANCE ASSOC BETWEEN
1950 TO 1980
SYSCO SOUTH FLORIDA INC - DUNS 194845012 SYSCO METRO NEW YORK
LLC - DUNS 003855640
HP ACTHAR GEL - AER 2011 TO PRESENT
THERMOREGULATION DVCS - CORR 8/30/17
LITHIUM: RISPERDAL PROLIXIN - APRVL
HILLTOP RESEARCH, PETERSBURG, FL - EIR 2/22-3/1/17
2017-7753
PFIZER - LETTERS, PRESENTATIONS RE MCPHERSON, KS FACILITY FEB
2017 TO PRESENT
RECS RE LABELING OF FOOD AS KEFIR ETC 04/01/2016 - 10/02/2017

MEDWATCH 6749915
K012868
AZACITIDINE AERS
LEVEOLEUCOVORIN CALCIUM AERS
CINQAIR AERS
Docket No. 1996-P-0301-CP
NOVARTIS BLA KYMRIAH MODULE 4
RESPICLICK AERS
KYOWA PHARMA, JAPAN - 483 01/01/2017 - 01/31/2017
K150960
K140178
FCN 1756
BUSHU PHARMACEUTICALS, JAPAN - 483 09/01/2016 - 09/30/2016
DSUMITOMO CHEMICAL, JAPAN - 483 09/02/2016 - 09/30/2016
NDA 22122
BIOCON LIMITED, BANGALORE, INDIA - EIR 05/25/2012 - 09/05/2016

GLATOPA AERS
CAMBRIDGE BRANDS, INC CHARMS LLC, TOOTSIE ROLL INC - 483, EIR,
ADVERSE DETERMINATION LETTERS 01/03/2011 - 10/02/2017
ARANESP SAFETY AND EFFICACY INFORMATION ETC
TRANSCRIPT OF TESTIMONY PAULA A MOYNAHAN, MD, RE SCULPTRA
CDRH COMMUNICATION RE MDR SYSTEM - SIGNAL SUMMARY DOCUMENT
WUXI APPTEC WUXI CITY - 482, FMD LETTER 05/01/2017 - 10/02/2017

BIOMET WARSAW, IN - 483 06/16/2014 - 02/10/2016
GLATOPA APPROVAL RECS
PMA P160030
IM HEALTHY SOYNUT BUTTER PRODUCTS RECALL RECS
MEDA MANUFACTURING GMBH, GERMANY - 483, EIR 01/01/2016 -
10/02/2017
Records of action taken against Indian manufacturers,
manufacturing sites and clinical research organisations
K032821
BIOVET JOINT STOCK COMPANY, BULGARIA - EIR 06/19/2017 -
06/23/2017
CORR, CALENDAR APPOINTMENTS, RECS BETWEEN FDA AND APPLE INC RE
DEVICES, SOFTWARE, ETC
COMPLAINT RECS
ANDA 202090
BOSTON SCIENTIFIC CORPORATION 515(I) SUBMISSION 8/14/96
MOMENTA PHARMACEUTICALS GLATIRAMER COMMUNICATIONS WITH FDA
PFIZER, INC COMMUNICATIONS WITH FDA RE WARNING LETTER
02/14/2017 - 12/31/2017
FCN 54
WARNING LETTER SPREADSHEET
DRUG MASTER FILE SPREADSHEET
COMMUNICATIONS BETWEEN FDA AND VAPOR TECHNOLOGY ASSOCIATION,

AMERICAN VAPING ASSOCIATION ETC 11/09/2016 - 12/31/2017
AKORN 483 04/01/2017 - 10/03/2017
AKRON 483 04/01/2017 - 10/03/2017
AKORN 483 01/01/2017 - 10/02/2017
AKORN, INC - 483 10/01/2016 - 10/03/2017
FOIA REQUESTS SUBMITTED BY COOK MEDICAL, GOODWIN PROCTOR
01/01/2013 TO PRESENT
8762291 9138849 9246695 ETC

FCN 351
FCN 47
FCN 476
ZS PHARMA, COPPEL, TX - 483 01/01/2016 - 10/03/2017
LASALLE COUNTY HEALTH DEPARTMENT, PEORIA, IL - TEST DATA,
METHOD FOR SAMPLES 08/21/2017 - 10/02/2017
MEDWATCH 6518306
MYLAN PHARMACEUTICALS, INC, MORGANTOWN, WV LOTUS LABS PVT,
LTD, BANGALORE, INDIA VI-JON, SMYRNA, TN - 483 08/01/2017 -
08/31/2017
COMPLAINT REFERENCED IN NUPLAZID CLINICAL INSPECTION SUMMARY

AKORN RECS 01/01/2017 - 10/03/2017
B BRAUN VENA TECH RECLASSIFICATION SUBMISSION RE CARDIOVASCULAR
INTRAVASCULAR FILTERS
Guidance for the submission of 510(k) premarket notifications
for cardiovascular intravascular filters
AKORN 483 01/03/2017 - 10/03/2017
DR WILLIAM LEWIS COVANCE DALLAS, TX - INPECTION RECS 01/01/2014
- 10/03/2017
K152432
DEPUY SYNTHES ATTUNE KNEE SYSTEM RECS 01/01/2010 - 10/02/2017

CORR BETWEEN FDA AND INTERCEPT PHARMACEUTICALS RE OBETICHOLIC
ACID
MEDICAL DEVICE REGISTRATION AND LISTING 01/01/2012 -
12/31/2016
FOIA REQUEST LOG 08/11/2017 - 10/04/2017
SPREADSHEET OF INSPECTIONNS - ANIMAL FOOD FACILITIES GMP
09/19/2016 - 10/03/2017
NDA 012283
OCALIVA 12904567 12965126 13097723 ETC
OCALIVA 13424267 13651412 13515063 ETC
10077346, 10420055, 10885228, ETC
EAST ORANGE GENERAL HOSPITAL, EAST ORANGE, NJ - MQSA INSPECTION
CERTIFICATION, REPORTS RE MAMMOGRAPHY EQUIPMENT 01/01/2005 -
01/01/2017
ARGININE MEDICATION ERRORS 10/01/2000 - 10/04/2017
IVY, DAVID DUNBAR, MD, AURORA, CO LEVIN, MYRON, AURORA, CO -
483
DIASOL EAST, INC SAN FERNANDO, CA - EIR, 483, CORR 02/21/2017
- 03/17/2017
CASE # 17-36516
CENTURION, HOWELL, MI - EIR 09/09/2015 - 09/21/2015
CENTURION, HOWELL, MI - EIR 03/04/2015 - 03/26/2015
CENTURION MEDICAL PRODUCTS CORPORATION EIR 08/30/2016 -
09/28/2016
NDA 206940 DRAFT LABELING, CORR ETC
NDA 022074 S 4
ORIGINAL FDA REVIEWS ABILIFY, CLOZARIL, FANAPT ETC
RECS REVIEW OFFICE OF NONPRESCRIPTION DRUGS RE LABELING FOR OTC
PROTON PUMP INHIBITORS ETC
BAUSCH AND LOMB, TAMPA, FL - EIR 05/15/2017 - 05/26/2017
ANDA 206094
PALISADES DENTAL LLC - IMPACT AIR 45 HANDPIECE FOR PERIODONTAL

USE K972376 IMPACT AIR 45 HANDPIECE FOR ENDONONTIC USE K972375
CENTURION, YUMA, AZ - EIR 03/20/2017 - 03/22/2017
NDA 020314 SBA
RECS RE REVIEWS OFFICE OF SURVEILLANCE AND EPIDEMIOLOGY CHRONIC
KIDNEY DISEASE AND USE OF PROTON PUMP INHIBITORS ETC
01/01/2010 - 10/04/2017
NDA 019882 SBA
Summary of application dates and application status for cancer
vaccine Vallovax from Batu Biologics located in San Diego
California
2013-5061
CPT1700423
TRULICITY AERS
RECS RE MR JARED WHAT, HI TECH PHARMACEUTICALS 10/01/2017 -
10/04/2017
MYLAN, MORGANTOWN, WV - 483
PFIZER/HOSPIRA - CAPA RECS RE WARNING LETTER, CAPA RECS FILED
BY PORTON BIOPHARMA LIMITED RE WARING LETTER 03/01/2016 -
10/08/2017
LORILLARD NOTICES OF INTENT REGARDING ELECTRONIC ADVERTISING
01/01/2010 - 12/31/2013
INDIVIOR CORR RE MORPHABOND REQUESTING A MEETING ETC
REYNOLDS NOTICES OF INTENT RE ELECTRONIC ADVERTISING
01/01/2010 - 12/31/2013
ANDA 077500 LABEL
CLEOCIN T SBA
CATALENT BELGIUM SA, CALALENT PHARMA SOLUTIONS INC, BRUSSELS,
BELGIUM - EIR 01/29/2013 - 02/12/2013
ITG NOTICES OF INTENT RE ELECTRONIC ADVERTISING 01/01/2010 -
12/31/2013
THALIDOMIDE RECS PREVIOUSLY RELEASED UNDER FOIA 01/01/1955 -
10/09/2017
ANDA 085979
Deficiency Letter issued 10.06.2017 regarding Drug Master File
(DMF) 019777 held by Abbey Color
ANDA: 085368
2013-7458
NADA 011-116 FEED ASSAY METHOD
BREAST IMPLANT ADVERSE EVENTS
BIOGEN CAMBRIDGE, CAMBRIDGE, MA - EIR 01/01/2015 - 12/31/2015

SAVAGE RIVER INC (DBA BEYOND MEAT) - SALMONELLA, LISTERIA
MONOCYTOGENES, LISTERIA SPP FINDINGS, CORR, RECALLS, ETC 2011
TO PRESENT
UNIMARK REMEDIES, INDIA - 483 10/09/2017 - 10/16/2017
10/05/2017
FCN 816
JIANGXI SENCEN HYGIENIC PRODUCTS CO - 483 01/01/2014 -
10/01/2017
CADILA PHARMACEUTICALS LIMITED, INDIA - 483 07/16/2016 -
07/22/2016
NOTICES OF INTENT RE ELECTRONIC ADVERTISING AMERICAN SNUFF
COMPANY 01/01/2010 - 12/31/2013
ANDA 064108 ANDA 075733
NOTICES OF INTENT RE ELECTRONIC ADVERTISING STOKER'S 01/01/2010
- 12/31/2013
RECS RE DECISION TO REMOVE ACTHAR GEL SYNTHETIC FROM LIST OF
DRUGS PUBLISHED IN ORANGE BOOK
SUN PHARMACEUTICALS INDUSTRIES LIMITED, HALOL, INDIA - 483
VYXEOS, SPINRAZA, INGREZZA ETC AERS
IMPOSSIBLE FOODS INC - INGREDIENT SAFETY, SOY ROOT NODULES,
GRAS RVW COMM, ETC
BUTTER FLAVORS, DIACETYL, MICROWAVE POPCORN, ETC - CORR, PHONE
LOGS, EMAILS, ETC
PRADAXA - AERS 2010 TO PRESENT
US PHARMACOEIA - REVISION TO PHARMACEUTICAL GLASS STANDARDS
2016-3315
JUSTIN GOODMAN, WHITE COAT WASTE PROJECT - FOIA REQUESTS 8/1/16
TO 10/4/17
ASTRAZENECA - LIDOCAINE OINTMENT NDA 08-048 PI, LBLG
CMPLNT FOR INJUNCTION, CONSENT DECREE - MIRA VIOLATIONS OF GMP
REGULATIONS NOTICE OF ADVERSE FINDINGS LTR 1986, ETC
COUNTY LIFE CO - CMPLNTS
BOTTLED WATER CMPLNT
VERIFICATIN THAT BOEHRINGER IGELHEIM FILED AN ADVERSE EVENT RPT
FOR PRADAXA
ELITE LABS - RECS
FOOD PROCESSORS- 483S 1/17 TO PRESENT
CONGRESSIONAL CORR 1/20/17 TO PRESENT
DRUG RECALLS 1990 TO 2010
PUMA BIOTECHNOLOGY - NERLYNX (NERATINIB) AERS 1/17 TO PRESENT

OPDIVO (NIVOLUMAB) - AERS 12/10 TO PRESENT
KEYTRUDA (PEMBROLIZUMAB) - AERS 9/12 TO PRESENT
TECENTRIQ (ATEZOLIZUMAB) - AERS 5/14 TO PRESENT
AJINOMOTO WINDSOR INC - READY-TO-EAT CHICKEN MEMOS, RPTS, LAB
TESTS, ETC
NATIONAL STEAK AND POULTTRY - READY-TO-EAT CHICKEN 11/23/16
RECALL RECS,
FDA CORR WITH AMGEN RE JUNCOS, PR FACILITY
LIST OF MEDICAL DEVICE COMPANIES REGISTERED IN COSTA RICA,
DOMINICAN REPUBLIC
Data used for recommendation given in the 9/6/2017 FDA Safety
Communication regarding sodium polystyrene sulfonate
AKORN 483, WARNING LETTER 03/01/2017 - 10/05/2017 PHILIPS,
CLEVELAND, OH CONVATEC
PHILIPS MEDICAL SYSTEMS, CLEVELAND, OH ESPERANZA ARCE-NUNEZ,
MIAMI, FL GADDAPOTHARAM, INDIA ETC EIR 10/15/2013 -
08/18/2017
K881813
CORR BETWEEN FDA AND MEDTRONIC RE PUERTO RICO FACILITIES 1/1/15
TO PRESENT
AMBIOPHARM, NORTH AUGUSTA, SC CHINA MENLO PARK, CA ETC - 483
01/01/2010 - 06/01/2017
CORR BETWEEN AMGEN AND FDA RE HURRICANE IRMA, MARIA
ONDANSETRON, PROMETHAZINE, DIPHENHYDRAMINE ETC AERS
CORR BETWEEN FDA AND MEDTRONIC RE HURRICANE IRMA, MARIA
PROFICIENT RX, LP - REGISTRATION, LABELER CODE, LISTINGS ETC
PHILIPS HEALTHCARE, CLEVELAND, OH - INSPECTION RECS 07/01/2017
- 08/31/2017
SUN PHARMACEUTICALS LTD, DADRA, INDIA - EIR 10/02/2017 -
10/09/2017
K163407
CLARIS INJECTIBLE LIMITED, INDIA - 483 07/27/2017 - 08/31/2017

NDA 009986 NDA 009766
K092503
K152111 K041623 K143191
SAMPLE SUMMARY 1020490
BLA 125472 S 24 SBA
NDA 020652
NDA 011683
CASE 12663751, 13346308, 13296768, ETC
AZRA RAZA MD - INVESTIGATION
MIMEDX.COM - RECS
SAMPLE OF BALANCED LOW RESIDUE DIET LOW FAT INTOLERABLE DIET,
VEGETARIAN DIET
SMOKIN JOES SE0004629, SE0004632, SE0004615, SE0004618
SE0004816
ASCOR (ASCORDIC ACID) NDA 09-112 SBA
SHELF LIFE EXTENSION PROGRAM - ACETIC ACID, ACETYCSTEINE,
ARGININE HYDROCHLORINE POWDER, ETC
FDA BLUEPRINT FOR PRESCRIBER EDUCATION FOR EXTENDED RELEASE &
LONG ACTING OPIOID ANALGESICS (CERTIFIED)
AKORN INC - 483 SINCE 10/16
KRAFT HEINZ CO - IMPORT ENTRIES THAT IDENTIFY THE FOREGIN
SUPPLIER VERIFICATION PROGRAM IMPORTER USING DUNS NUMBERS
080248592, 079320220 5/30/17-8/31/17
RECS RE NESTLE WATERS NORTH AMERICAN ARROWHEAD 04/04/2017 -
04/18/2017
ADCO BILLING SOLUTIONS - LABELER CODE FORMS, PRODUCT LISTINGS,
REGISTRATIONS ETC
RECS RE DE NOVO CLASSIFICATION NO BRAINPULSE MODEL 1100
SPRUCE HAVEN FARM AND RESEARCH CENTER, UNION SPRINGS, NY - EIR
01/02/2009 - 10/06/2017
DEN160018 PEAR THERAPEUTICS, INC.
UC DAVIS, TULARE, CA - EIR 01/02/2009 - 10/06/2017
PHILIPS ULTRASOUNDS INC, BOTHELL, WA PHILIPS VISICU,
BALTIMORE, MD SPECTRANETICS, FREMONT, CA - 483
BIO AGRI MIX LP, ONTARIO, CANADA - EIR 01/02/2016 - 12/31/2016

BIOVET PESTERA BULGARIA - EIR 07/01/2013 - 11/30/2017
SHADONGQILU, CHINA - EIR 08/01/2011 - 05/06/2015
PRECISION SCIENCE, PHOENIX, AZ - 483 01/01/2009 - 12/31/2011

SEATTLE GENETICS - EIR, 483 06/09/2015 - 10/06/2017
RECS RE SAMPLE 1021377
PRECISION SCIENCE, PHOENIX, AZ - EIR, 483 01/02/2014 -
12/31/2016
K163431 NOTES, MEMOS, COMM
ZOETIS ITALIA SRL - 483 01/02/2016 - 10/06/2017
INDIVIDUAL RECS
VENCLEXTA ANALYTICAL METHODS
MW5065617 RECS
CAERS REPORTS
ADB INTERESTS, LLC, ASHLEY BLACK, ADB INNOVATIONS, PEARLAND, TX

- INSPECTIONS, CORR, RECALL ETC 08/01/2017 - 10/09/2017
BLA 761044
FOIA LOG ABBOTT LABORATORIES 09/19/2017 - 10/02/2017
K170568
K170155
JUAN MANUAL RODRIGUEZ DEBARMENT RECS
SAFETY ANNOUNCEMENT
COMPLETE RESPONSE LETTER DR REDDY'S LABORATORIES LTD ANDA
BUPRENORPHINE/NALOXONE
CORR WITH DR GOTTLIEB RE HURRICANE
SPECTRUM MANUFACTURING CORP, GARDENA, CA - EIR 01/01/2014 -
10/01/2017
SPECTRUM MANUFACTURING CORP, NEW BRUNSWICK, NJ - EIR
01/01/2014 - 10/01/2017
PHARMATECH LLC, DAVIE, FL - EIR 01/02/2012 - 10/09/2017
FAERS 13612028
PHILIPS HEALTHCARE, PHILIPS MEDICAL SYSTEMS, PHILIPS MEDICAL
SYSTEMS PUERTO RICO ETC 483 01/01/2015 - 12/31/2017
NDA 206977
NDA 019439
FOOD INDUSTRY COUNCIL, WILWAUKEE, WI - INSP
MEDICAL DVCS REGISTERED IN COSTA RICA & DOMINICAN REPUBLIC 2007
- 2017
STRYKER LETTER REGARDING FORCED AIR THERMAL REGULATING SYS
ANDA 75-23 SBA
K030947 K121048 K140472 ETC
K964622 K980866
AZRA RAZA MD ST LUKES MEDICAL CENTER - INVESTIGATIONS,
INSPECTIONS ETC 01/01/1990 - 10/10/2017
COMPLETE RESPONSE LETTER MYLAN NV, BIOCON LTD MYL-1401H
510K PULSE BIOSCIENCES PULSETX SYSTEM, INTERACTIVE REVIEW,
SUBSTANTIVE REVIEW ETC
KCI USA, SAN ANTONIO, TX - EIR 04/01/2017 - 10/01/2017
Correspondence regarding Eden Creamery/Halo Top products
AKORN - 483, WARNING LETTERS 01/01/2017 - 10/10/2017
KBI BIOPHARMA, BOULDER, CO - INSPECTION RECS
NDA 019625/S-024
ANDA 206936 ANDA 091646
K780393 P790028 P800032
NDA 050717 SBA, REVIEWS
K920438, K922997, K935778
NEUSOFT MEDICAL SYSTEMS CO, LTD, CHINA PHILIPS MEDICAL
SYSTEMS, CLEVELAND, OH PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
- 483 09/11/2008 - 02/04/2016
FDA-1999-P-1855
MYL-1401H COMPLETE RESPONSE LETTER
CONCERTA PK DATA
MYLAN, BIOCON COMPLETE RESPONSE LETTER PEGFILGRASTIM
ANDA 07-8711
K163399
ADVERSE EVENTS TROTEC LASER GMBH
INDIVIDUAL RECS
INDIVIDUAL RECS
STRYKER - AERO-C ANTERIOR CERVICAL INTERBODY AND FIXATION SYS
RECALLS, NOTICES, VIOLATIONS, ETC
K1222252
MEDWATCH Adverse Event
RECS RE BHT IN FOOD PRODUCTS
VERTEX PHARMACEUTICALS, INC, CAMBRIDGE, MA - EIR 02/01/2015 -
10/31/2015
DR STEPHANE DE BOTTON, EIR AG221-C-001 PROTOCOL
FDA DRAFT STRATEGIC PLAN FY 2019, PERFORMANCE PLAN
DEN160001 DEN140019
UNIMARK REMEDIES LIMITED, INDIA - 483 09/20/2017 - 09/30/201

FOIA LOG ST JUDE MEDICAL 09/19/2017 - 10/02/2017
CHIEF PHARMACY OFFICER, UNIVERSITY OF MICHIGAN MEDICAL CENTER,

ANN ARBOR, MI - 483, EIR, CORR 06/06/2016 - 06/29/2016
LOUISVILLE REPRODUCTION CENTER, LOUISVILLE, KY - 483, EIR, CORR
06/07/2017 - 06/15/2017
MICRO THERAPEUTIC RESEARCH LABS, INDIA - 483, WARNING LETTER,
EIR ETC 10/01/2010 - 10/13/2017
GRUPP STEPHAN, CHILDRENS HOSPITAL OF PHILADELPHIA,
PHILADELPHIA, PA - 483, EIR, CORR 03/31/2017 - 05/13/2017
KUNDRANDA, MADAPPA (BANNER HEALTH), GILBERT, AZ - 483, EIR,
CORR 02/27/2017 - 03/13/2017
KNOWLES SURGERY CENTER, LOS GATOS, CA - 483, EIR, CORR 2/2/17
UNIVERSITY OF VIRGINIA SCHOOL OF MEDICINE, CHARLOTTESVILLE, VA

- 483, EIR, CORRD 03/06/2017 - 03/09/2017
GROAH, SUZANNE, MEDSTAR NATIONAL REHABILITATION - 483, EIR,
CORR 03/28/2017 - 04/04/2017
MB INDUSTRIA CIRURGICA LTDA, PAULISTA, PE, BRAZIL - 483
03/13/2017 - 03/16/2017
TUBILUX PHARMA SPA, ITALY - 483 12/01/2016 - 12/09/2016
ZIZHU PHARMACEUTICAL CO LTD, CHINA - 483 11/28/2017 -
12/01/2016
Silicone Devices Affected by WithdRawal of Dow Coming Silastic
Materials Alternative Review Procedure Guidance
UCSF BENIOFF CHILDREN'S HOSPITAL, OAKLAND, CA - EIR 09/05/2017
- 10/12/2017
LAVEEZA BHATTI, MD, BEVERLY HILLS, CA - EIR, 483, CORR
10/27/2016 - 12/16/2016
OPTION CARE ENTERPRISES, INC BANNOCKBURN, IL - EIR, 483, CORR
09/01/2016 - 09/21/2016
K081858
LIST OF HARMFUL AND POTENTIALLY HARMFUL CONSTITUENTS
NDA 018342 SBA
CDER 21ST CENTURY REVIEW PROCESS, DESK REFERENCE PROCESS
PHARMARON, CHINA - 483
FOIA LOG 01/01/2015 - 10/11/2017
RECKITT BENCKISER, FORTH WORTH, TX - EIR, 483, CORR 3/4/13
NELSON LABORATORIES, SALT LAKE CITY, UT - EIR, 483, CORR
2/26/16
PRESERVATION SOLUTIONS, ELKHORN, WI - EIR, 483, CORR 8/31/15
RICERCA BIOSCIENCES, PAINESVILLE, OH - EIR, 483, CORR 5/29/15

POLAR PRODUCTS, STOW, OH - EIR, 483, CORR 3/23/17
ISO-TEX DIAGNOSTICS, ALVIN, TX - EIR, 483, CORR 7/10/15
MAXILON LABORATORIES, AMHERST, NH - EIR, 483, CORR 3/7/17
GRIFOLS PLASMACARE, MILWAUKEE, WI - EIR, 483, CORR 9/9/16
FCN 1478
AURISCO PHARMACEUTICAL CO LTD, CHINA - EIR 11/01/2013 -
11/30/2013
AFOXOLANER, FLURALANER, SAROLANER AERS
BIOGEN, CAMBRIDGE, MA - EIR 06/15/2015 - 07/15/2015 see
attached email
BACHEM AMERICAS, TORRANCE, CA - EIR, 483, CORR 2/25/16
AKORN, DECATUR, IL - EIR, 483, CORR 6/10/16
K943801
ANDA 086195
K171540
K150486
K160295
NDA 011752
NDA 022406 NDA 022439
2017-508, 2017-785, 2017-290
APPLE WATCH - HEART RATE FEATURE REGULATORY STATUS
MRK S WILLNER MD, NORTH MIAMI RESEARCH, MIAMI, FL - 483, EIR
7/14/08
JAMIESON, WINDSOR ON, CANADA - FORM 3500A, 3500B 7/1/17 TO
9/30/17
PARAGON VISION SCIENCES, MESA, AZ - EIR 2016
2017-7753
TRIMETAZIDINE NDA
SEASPINE, CALRSBAD, CA - EIR 11/17/16
PHARMACIA - CLINDAMYCIN PHOSPHATE NDA 50-600 SBA
PIZZA RANCH INC - E COLI OUTBREAK 2015 TO 2016
SMOKIN JOES - SE 0004615, 4618, 4629 ETC UNREDACTED
2Q17 CASES IN AERS SEE ATTACHED
INVOKANA NDA 20-4042 DAPAGLIFLOZIN NDA 20-2293 EMPAGLIFLOZIN
NDA 20-4629 RVWS
MAI HYDROGEL IMPLANT FOR SCLERAL BUCKLING 510K
DAIL LOG 9/11-15/17
FAP OA 4226
RECS FROM JAMES KLETT, PHOENIX TO FDA RE WARNING LETTER RECS
RE WARNING LETTER
2016-8809
2017-3749
2017-6702
2017-6768
2017-6787
2017-7187
2017-7421
2017-7856
2017-7962
2010-6282
2017-5281
2010-6283
XIAN LIJUN PHARMACEUTICAL CO, CHINA - EIR 01/01/2014 -
10/12/2017
AUGMENTIN ABBREVIATED ENVIRONMENTAL ASSESSMENT, FONSI
DR HOGOP KANTARJIAN, MD ANDERSON, HOUSTON, TX - EIR
DR EYTAN STEIN MEMORIAL SLOAN KETTERING CANCER CENTER, NEW
YORK, NY - EIR
ABILIFY, GEODON, SEROQUEL ETC AERS
NDA 012750
REPRO-MED SYSTEMS, INC, DBA RMS MEDICAL PRODUCTS, CHESTER, NY -
EIR 06/03/2015 - 02/26/2016
INSULIN, GLUCAGON AERS
NDA 019614 SBA
ANDA APPROVAL LETTERS
SHAKLEE CORPORATION - CORR WITH FDA RE NUTRITIONAL SUPPLEMENTS
01/01/2010 - 10/13/2017
DIASOL INC, NJ - EIR, 483, CORR 05/08/2017 - 06/15/2017
KAMRAN AYUB, OAK LAWN, IL - EIR, 483, CORR 05/18/2015 -
07/08/2015
ZIMMER INC - EIR, 483 01/01/2011 - 12/31/2014
FOIA LOGS 07/27/2016 to 10/16/2017
K001781
Any and all mandatory and voluntary medical device reports with
respect to Medtronic Universal Cannulated Screws
UPDATE OF CDER ANDA SPREADSHEET 08/01/2017 - 10/20/2017
Custom Device Annual Reports for Materialise
INDIVIDUAL RECS
K061065
K131686 K143213
EPIGENOMICS, GERMANY - EIR 06/26/2017 - 06/29/2017
8/28/02 MEETING MINUTES CDER
ANDA 077414
RECS RE DIAGEO BULLEIT FRONTIER WHISKEY BULLEIT WHISKEY
2017-6354 FOLLOW UP RECS

GP PHARMA SA - RESPONSE TO CDER 01/01/2015 - 12/31/2015
K110486
IDT BIOLOGIKA, GERMANY - EIR 01/01/2016 - 12/31/2016
RECS RE CANDY MADE WITH CANNABIDIOL
NDA 018342 LABELING PACKAGE INSERT
CORR TO NATIONAL ANIMAL SUPPLEMENT COUNCIL FROM CVM RE
REGULATION OF DIETARY SUPPLEMENTS IN ANIMALS
UPDATE TO SPREADSHEET OF CDER NDAS
Threshold of Regulation (TOR) Exemption No. 2016-002, including

all chemistry, toxicology, and environmental review memoranda
that were developed by FDA in support of TOR 2016-002
ELITE LABORATORIES, NORTHVALE, NJ - INSPECTIONS, WARNING
LETTERS 01/04/2016 - 10/12/2017
AKORN, COPIAGUE, NY - 483 07/31/2017 - 08/04/2017
FARMERS RICE COOPERATIVE, CALIFORNIA - REPORTS, AGREEMENTS,
GRANTS, ETC 01/01/2006 - 12/31/2015
CORR BETWEEN FDA AND JANSSEN, ETHICON, JOHNSON & JOHNSON RE
INVOKANA 01/01/2009 - 10/13/2017
RECS RE DANIEL MCCHESNEY AND PURINA PET FOOD RE BEYOND THE
BOWEL SYMPOSIUM 09/01/2016 - 09/30/2017
RECS RE FDA PRIORITY REVIEW PANEL AND CARL JUNE RE KYMRIAH
01/01/2016 - 10/13/2017
RECS RE FDA PRIORITY REVIEW PANEL AND NOVARTIS RE KYMRIAH
01/01/2016 - 10/13/2017
FDA/CBER/APLB Notice of Violation Letters
AMA LABORATORIES, NEW CITY, NY - 483 01/01/2014 - 10/13/2017

RECS RE DRUGS APPROVED BASED ON FOREIGN CLINICAL STUDIES
01/01/2010 - 10/13/2017
PHILIPS MEDICAL SYSTEMS NEDERLAND BV, ETC - INSPECTION RECS
10/01/2016 - 10/01/2017
ANDA 072736, ANDA 072735 , ANDA 072734, ETC LABEL, PACKAGE
INSERT
K140866
LUPIN, INDORE, INDIA - 483 01/01/2017 - 10/31/2017
NDA 019853 LABELING SUPPLEMENT
FOIA DAILY LOG 06/01/2017 - 10/13/2017
NDA 018686 SBA
INDIVIDUAL RECS
B. BRAUN MEDICAL, IRVINE, CA - 483 01/01/2007 - 10/14/2017
FOOD CONTACT SUBSTANCE NOTIFICATIONS
FAERS CASE REPORTS
LIST OF INSPECTIONS 10/15/2016 - 10/15/2017
2017-7509 REQUEST LETTER ONLY
ANGIO DYNAMICS INC K151724
ANGIO DYNAMICS K061733
ZIMMER BIOMET INC, WARSAW, IN - EIR 9/12/16 TO 11/22/16
CORR FROM REP RYAN COSTELLO 1/15 TO PRESENT
MANUFACTURER, DISTRIBUTOR OF OPIOIDS - MEMOS, A/C MTG MINS,
SAFETY RECS, ETC (CERTIFIED)
NSAID - EFFICACY
BIOCON LTD PEGFILGRASTIM COMPLETE RESPONSE LETTER 10/09/2017 -
10/10/2017
NDC LIST
MS CONTIN ORIGINAL SCIENTIFIC STUDIES 01/01/1995 - 12/31/1995

PHILIPS, CLEVELAND, OH BOTHEL, WA ANDOVER, MA - 483
10/01/2010 - 10/31/2017
GRIFOLS IND STUDY POCLEIX BABESIA ASSAY G
OCALIVA AERS
FAERS REPORTS
2017-7823
K130631
AMGEN, BOULDER, CO - 483 04/11/2000 - 05/09/2007
Ethyl Esters of Fatty Acids for Dehydration of Grapes to
Raisins GRAS 6G0312
LTV SERIES 950 VENTILATOR AERS 01/01/2007 - 09/01/2015
95 percent confidence intervals around the median calculated
from the NHANES 2003-2008 consumption data for soup, used to
determine whether to update the RACC for soup
FAERS CASES
OXYCONTIN SCIENTIFIC STUDIES FOR APPROVAL
K844630
BOB COSMAN CO INC DBA GOSMAN'S FISH MARKET INC - RECS, WARNING
LETTER, INVESTIGATIONS
INSPECTIONS DATABASE
K163118 K150313
ANDA 061212 SBA
ANDA 204403 SBA
K163614
K013597 K062438
NDA 012283 ANDA 086831
ANDA 203690
K160602
NUPLAZID AERS
NERATINIB AERS
BORTEZOMIB IND
FEDERAL EMPLOYEE VIEWPOINT SURVEY RECS 10/01/2017 - 10/17/2017

NDA 207648
K022995
FDA/CDER Certificates of Pharmaceutical Products (CPPs) from

the application numbers: 08-10371-17 and 09-11408-17 CERTIFIED
BIOGEN MA, CAMBRIDGE, MA - 483, EIR 09/22/2015 - 09/26/2015
K101535
K061451
VALBENAZINE AERS
INAD 012183
2017-7776
PRODUCT QUESTION MANUFACTURING LLC, HOLLY HILL, FL - EIR
02/09/2015 - 10/17/2017
CORR BETWEEN FDA AND PURINA RE COMPLAINT 150560
STATE NOTIFICATIONS
PARAGON BIOTECK, INC - 483 03/21/2013 - 10/17/2017
K090996
ZOETIS ITALIA SRL - EIR 01/02/2015 - 01/02/2016
PLASMA BIOLOGICAL SERVICES, BIOLOGICAL SERVICES, COLUMBIA, MO -
483 01/01/2010 - 10/17/2017
SORIN GROUP GERMANY - EIR 04/11/2011 - 04/13/2011
DATASETS ON SALES OF FERTILIZERS CONTAINING PHOSPHOGYPSUM ETC
01/01/2012 - 10/01/2017
K052596
K012445 K951531
K153591
TYSON FOODS INC. SEDALIA, MO NEW HOLLAND, PA SPRINGDALE, AR,
ETC - RECS 2013 TO PRESENT
K122252
SAVE MART COMPANIES - FOREIGN SUPPLIER VERIFICATION PROGRAM
IMPORTER USING DUNS NUMBERS 007874480, 011502858, 062192260,
ETC
NUTRICIA, NUTRICIA NORTH AMERICA, SHS INTERNATIONAL LTD -
NEOCATE REGULATORY ACTION, REGULATORY EXEMPTION
PHOTO ID 17WA003943
AMNEALPHARMS - DICLOFENAC SODIUM 1% TOPICAL GEL ANDA 208-077
SBA
ISRS 13100207, 13343982, 12607845, ETC

INDIVIDUAL RECS
PHARMACEUTICAL, BIOLOGICS, MEDICAL DVC MFG FACILITIES, ETC IN
AND OUTSIDE THE US - 483S 9/1-30/17
FOI DAILY LOG 2017
EMBRIA HEALTH SCIENCES LLC, ANKENY, IA DIAMOND V MILLS, CEDAR
RAPIDS, IA - INSPS
CYNOSURE INC - AFFIRM WITH XPL HANDPIECE AND ER YAG LASER MODEL
K080006
ENFIT ENTERAL PRODUCT STUDIES - CORR, STUDIES, CONTRACTS, ETC
1/1/14 TO PRESENT
ANALYTICAL RESULTS 98 SAMPLES LEIGH AND MACMAHON 2017
INDIVIDUAL RECS
INTUITIVE SURGICAL ION FLEXIBLE CATHETER, FLEXIBLE TUBE 510K
RECS
K112278
SAMSUNG BIOLOGICS CO LTD, KOREA 01/01/2016 - 483
RADICAVA UNREDCATED RECS
LOG OF CORR WITH REP MIKE MILLER 01/01/2013 - 10/17/2017
INDIVIDUAL RECS
VENLAFAXINE AERS
INDIVIDUAL RECS
SIMPLY NATURAL FOODS, COMMACK, NY - EIR 0/01/2015 - 10/10/2017

FDA 2830 forms for 2010
IMBRUVICA OPD RECS
STATUS OF PERSONNEL CMPLNT
RECS RE AQUABOUNTY TECHNOLOGIEGS ACQUISITION BELL FISH COMPANY
ETC
FAP 0M4181
IMRUVICA- NDA 205552 SBA
DIASOL, INC, SAN FERNANDO, CA - 483, EIR, CORR 06/06/2017 -
06/21/2017
XIFAXAN AERS
FLORIDA ATLANTIC UNIV - GRANTS, PROPOSALS FOR GRANT 2010 TO
2017
FAP 1M4727
PROCADIA XL APPROVAL PACKAGE RECS
NDA 009190 SBA
NUMBER OF PEOPLE IN OREGON WHO HAVE BEEN PRESCRIBED
PERSCRIPTION MEDICATION FOR DEPRESSION AND OR ANXIETY IN 2005
AMOUNT PRESCRIBED IN 2015-2016
LOUIS BARLETTA - CORR 1/3/11 TO PRESENT FOI RESQUESTS
REGARDING LOUIS BARLETTA 1/3/11
OXYCONTIN APPROVAL LIST OF FDA EMPLOYEES
CPT1700804
NDA 020262 AERS
DEN130051
FDA SOL-17-1180187
All Human Drug labelers registered annually at FDA for period
1990 through 2017
7145692 3837774 6230330 ETC
GELEST, INC, MORRISVILLE, PA - 482, 483, RECALLS ETC 10/01/2014
- 10/19/2017
KELYNIAM GLOBAL INC, CANTON, CT - EIR, 483, CORR 05/10/2017 -
05/30/2017
YOU BARS, MONTEREY PARK, CA - EIR 10/01/2015 - 10/10/2017
FLORIDA DEPT OF CORECTIONS - CMPLNT FORMS
DOG AND CAT PET FOOD, PET TREATS - AERS 1/10 TO PRESENT
K130164
K100384
K100415
INDIVIDUAL RECS
BECTON DICKINSON, COLUMBUS, NE - EIR 01/01/2014 - 10/19/2017

01/01/2017 - 10/19/2017 FOIA LOGS
52-08 ALERT
K161237
K163070
INDIVIDUAL RECS
PAROMOMYCIN, DESI LOG ETC

BLUE BELL CREAMERIES - INSPECTION RECS, CORR 10/01/2016 -
10/19/2017
MEETING TRANSCRIPTS
FDA PROCUREMENT OF CLOUD CONTENT MANAGEMENT SOFTWARE FROM BOX -
CONTRACT, EVALUATION OF VENDORS
WEST-WARD/HIKMA - COLUMBUS, OH WEST-WARD/HIKMA, CHERRY HILL,
NJ ETC - CORR, INSPECTIONS 03/31/2017 - 10/19/2017
SYNTHO CHILE LTDA, CHILE - CORR, INSPECTIONS 01/01/2016 -
10/19/2017
K152319, K131861, K141822, ETC
SYNTHON, CHILE - INSPECTION RECS 01/01/2015 - 10/19/2017
RECS RE KITE PHARMACEUTICAL KTE-C19
CONSUMER COMPLAINT PFANSTIEHL INC
2016-3554
ABBEY COLOR, INC 1/20/15
STRYKER STANDARD VIEDO CART WITH MONITOR INSP RECS, APRVL RECS
ADEQUAN APPLICATIONS, STUDIES
PROFICIENT RX - INSPECTION RECS
FDA Food Code 2013 in a machine readable comma separated values
(CSV) format
JOHN E BAILEY, JR - SALARY RECS 11/01/1992 - 01/01/2003
INDIVIDUAL RECS
CORR RE MEETINGS BETWEEN CFSAN AND PLANT BASED FOODS
ASSOCIATION RE LABELING OF PLANT BASED FOODS
Information and records concerning the public meeting entitled
Role of Naloxone in Opioid Overdose Fatality Prevention held on
Thursday, April 12, 2012
PATENT EXCLUSIVITY FOR NDA

OMONTYS RECALL ETC
ANDA 90589 COMMUNICATIONS
K142417
GLENMARK PHARMACEUTICALS LIMITED, INDIA - GMP CERTIFICATE FOR
INSPECTION OR EIR SUMMARY 12/12/2016 - 07/31/2017
INDIVIDUAL RECS
K974654, K042380, K030808, ETC
K112870 REMOVAL RECORDS
DIETARY SUPPLEMENT AERS
IMBRUVICA MEDICAL REVIEW RECS
Submissions to FDA requesting, and FDA's responses granting
or denying, a labeling exemption under 21 C.F.R. 101.100(g)
FOIA LOG 10/01/2016 - 10/01/2017
K153489
Bob Gosman Co. Inc., redacted HACCP records for fresh tuna
01/01/2017 - 10/01/2017
K162042
LIST OF GMP INSPECTIONS 21 CFR Part 111 - 01/01/2017 -
09/30/2017
METHADONE HYDROCHLORIDE TABLETS WARNING, ETC
SOUTHERN STATES COOPERATIVE, CAMPBELLVILLE, KY ETC EIR
09/19/2016 - 10/23/2017
MYLAN CORR WITH FDA RE ANDA 091646 ANDA 206936 ETC
PRIORITY REVIEW VOUCHERS HUMAN DRUGS, NME 01/01/1992 -
10/23/2017
NDA 011287
NEULASTA COMPLETE RESPONSE LETTER
RECS RE NOTIFICATION FOR NEW DIETARY INGREDIENT 953 AND HIGHER

ANDA 206936 ANDA 206921 ANDA 206767 ETC
FAERS RECS
SUPERDIMENSION INREACH 510K
SPINRAZA/NUSINERSEN IND RECS 01/01/2000 - 12/23/2016
VERAN'S SPIN SYSTEM 510K
NOVARTIS, MORRIS PLAINS, NJ - 483 12/02/2016 - 06/30/2017
BIDART BROS CALIFORNIA LISTERIA RECS 01/01/2014 - 10/23/2017

INDIVIDUAL RECS
K161332
BRAVECTO COMPLAINT RECS
Discontinued Drug Product List 01/01/2005 - 01/01/2016
K032301
K042901
K993951
METFORMIN AERS
K132936
QPSI, FLORENCE, NJ - EIR 10/01/2015 - 10/10/2017
BIO BOTANICA, HAUPPAUGE, NY - EIR 10/01/2015 - 10/10/2017
RECS RE GREEN CHILI CONCEPTS, LLC, LAS CRUCES, NM - INSPECTION
RECS ETC 01/01/2017 - 10/24/2017
CFSAN FOIA REQUEST 09/29/2017 - 10/24/2017
COMM BETWEEN NATURMED DBA VIBRANT LIVING, CAMP VERDE, AZ RE
ALL DAY ENERGY GREENS 01/01/2014 - 12/31/2016
ZENGAR INSTITUTE, NEUROPTIMAL CASE #535605 RECS RE CLAIMS
K162205
RESHAPE MEDICAL, SAN CLEMENTE, CA - EIR 11/01/2016 - 11/03/2016

K172881
COMMAND MEDICAL PRODUCTS, ORMOND BEACH, FL - EIR
2004-15759
YICHANG SANXIA PHARMACEUTICAL CO LTD, CHINA - 483 7/15/16
ZONALON - Doxepin Hydrochloride Cream - Topical 5% Mylan
Pharmaceuticals SBA
XULANE AERS
CINCINNATI SUB ZERO, CINCINNATI, OH - EIR 01/18/2017 -
10/24/2017
2017-7365, 2017 - 7367, 2017 - 7368, ETC
ACCELERATED ANALYTICAL LABS INC, MILWAUKEE, WI - EIR 05/25/2017
- 10/24/2017
FCN No. 1770 DIAM BOUCHAGE SAS
2012-2084
ALEXION PHARMACEUTICALS, SMITHFIELD, RI BIOGEN INC, CAMBRIDGE,
MA - 483 06/22/2015 - 07/21/2017
FDABF-GRAS-385 FDABF-GRAS-238
PPI CLASS REVIEWS, FAERS ETC
NDA 019698 LABELING
NDA 009866 SBA
ANDA 078702 SBA
NDA 209112
US Patent No. 8,703,823 B2 IND

ANDA 204383
NDA 020544 ETC
CLARIS INJECTABLES LIMITED, AHMEDABAD, INDIA - 483 01/01/2015 -
12/31/2015
NDA 50-578, SUPPL-61
All Adverse Event reports associated with Octagam 10%
NDA 21-572/S-023
NDA 209112
CLARIS INJECTABLES LIMITED, AHMEDABAD, INDIA - 483 01/01/2016
- 12/31/2016
SBOA for: Bumetanide Tablets, 2 mg - from Sandoz
CHIPOTLE MEXICAN GRILL INC - FOOD SAFETY ISSUES RELATED TO E
COLI, SALMONELLA, NOROVIRUS TRANS, MEMOS, EMAILS, ETC
ANESTHETIC AND ANALGESIC DRUG PRODUCTS A/C - TRANS 11/24-25/14

ASBESTOS IN TALC - RPTS, STUDIES, TESTING, ETC 1940 TO 1990
TESTING OF TALC, SOAPSTONE, OR SIMILAR MINERALS TO DETERMINE
ASBESTOS CONTENT
RIDGE PROPERTIES, LLC, DBA PAIN RELIEF NATURALLY, SALEM, OR -
EIR, 483, CORR 02/28/2017 - 03/16/2017
L'OREAL - NEW REVITALIFT TRIPLE POWER CONCENTRATED SERUM
TREATMENT - CMPLNT, RPT
MAGELLAN DIAGNOSTICS, INC, NORTH BILLERICA, MA - EIR, 483, CORR
05/10/2017 - 06/29/2017
K040980
UVLRX THERAPEUTICS, INC, OLDSMAR, FL - EIR, 483, CORR
03/27/2017 - 04/04/2017
PHARMACEUTICAL, BIOLOGICS, MEDICAL DVC MFG FACILITIES, ETC IN
AND OUTSIDE THE US - 483S 8/1-31/17
K113572
COGMEDIX, WORCESTER, MA - 483 01/01/2013 - 12/31/2013
INDIVIDUAL RECS
K113728
VARIAN IX, TRILOGY 6MN BEAMS - INVESTIGATION, CMPLNT 5/17 TO
8/17
PPD BIOANALYTICAL LAB, DABNEY ROAD, RICHMOND, VA PPD PHASE 1,
AUSTIN, TX PPD GMP LAB, MIDDLETON, WI - EIR
2017-7246
LIST OF PENDING FOIA REQUESTS 01/20/2017 - 10/29/2017
BECTON DICKINSON & CO, SPARKS, MD 8/4/17 WILLIAM H THEODORE,
BETHESDA, MD 8/8/17 - 483S
RXQ COMPOUNDING LLC, ATHENS, OH 8/8/17 DIAMOND WIPES
INTERNATIONAL INC, BUCYRUS, OH 8/9/17 - 483S
OPTION CARE, HOUSTON, TX 8/2/17 ALCON RESEARCH LTD, FORT

WORTH, TX 8/4 LINCARE INC, LITTLE ROCK, AR 8/22/17, ETC - 483S
CME AMERICA LLC, GOLDEN, CO 8/1/17 ZYNEX MEDICAL INC, LONE
TREE, CO 8/8/17 SYNCARDIA SYSTEMS LLC, TUCSON, AZ 8/18/17 -
483S
RANIR LLC, GRAND RAPIDS, MI 8/16/17 ATS MANUFACTURING LLC,
ELKHART, IN 8/18/17 - 483S
PROSUN INTERNATIONAL LLC, SAINT PETERSBURG, FL 8/4/17 HORIZON
PHARMACEUTICALS INC, RIVIERA BEACH, FL 8/5/17 HECTOR S
RODRIGUEZ MD, CORAL GABLES, FL 8/10/17- 483S
ILLINOIS TOOL WORKS INC, OLATHE, KS 8/4/17 KATALYST SURGICAL
LLC, CHESTERFIELD, MO 8/7/17 CUSTOM RX LLC, WICHITA, KS
8/15/17, ETC - 483S
MR INSTRUMENTS INC, MINNETONKA, MN 8/2/17 EDEN PRAIRIE, MN
8/18/17 - 483S
ENERCON, GRAY, ME 8/3/17 ADVANCED INSTRUMENTS LLC, NORWOOD, MA
8/4/17 MEM INC, MADISON, CT 8/9/17, ETC - 483S
OSTEOTECH INC, EATONTOWN, NJ - 483 8/10/17
SMITH & NEPHEW INC, MEMPHIS, TN 8/2/17 BIOMEDICAL RESEARCH

FOUNDATION OF NORTHWEST LOUISIANA, SHREVEPORT, LA 8/9/17 - 483S
INTELLEWAVE LLC, VALLEY STREAM, NY 8/2/17 POLYMEDCO INC,
CORTLANDT MANOR, NY 8/3/17 DAVID H HYMAN MD, NEW YORK, NY
8/1/17, ETC - 483S
BAYER HEALTHCARE LLC, MYERSTOWN, PA 8/11/17 ASHUTOSH P JADHAV
MD PHD, PITTSBURGH, PA 8/1117 - 483S
IMPAX LABORATORIES INC, HAYWARD, CA - 483 8/23/17
SURGIMARK INC, YAKIMA, WA 8/8/17 BZ MEDICAL INC, PORTLAND, OR
8/15/17 CADWELL INDUSTRIES INC, KENNEWICK, WA 8/16/17, ETC -
483S
RECS RE Docket Number FDA 2011-P-0741
EMAILS BETWEEN THOMAS J ARISTA AND MASSOUD MOTAMED RE CLARIS

INJECTABLES LIMITED, INDIA INSPECTION 07/26/2017 - 08/11/2017
Intuitive Surgical for the da Vinci Sp (single port) system,
particularly related to 510k filings
NUVARING RECS RE RISK OF THROMBOSIS
CPT1700444
7R01FD005406-02PHASE I STUDY OF VIRALYM-A FOR THE TREATMENT
OF ADENOVIRUS DISEASE - IND16258 (11/13/2014) KAKARLA, SUNITHA
VIRACYTE, LLC
NDA 018450
SOHAIL M KHAN, MD, LYNN HAVEN, FL - EIR, 483, CORR 7/14/17
AEROSOL AND LIQUID PACKAGING, INC, BALTIMORE, MD - EIR
04/01/2014 - 12/30/2016
BENTLEY LABORATORIES, LLC, EDISON, NJ - EIR 06/05/2017 -
08/01/2017
PHARMAVITE LLC, OPEKILA, AL - COMM, REPORTS ETC 01/01/2016 -
10/26/2017
FDA communications with Altria Group/Philip Morris
INSPECTIONS DATA
K040836
DESYREL PACKAGE INSERTS, LABELS, MEDICATION GUIDES ETC
BIO-RECOVERY MEETING WITH FDA TRANSCRIPT
Cohort Identification and Analysis tool (CIDA) and propensity
score matching (PSM) tool used in the Mini-Sentinel "PROMPT:
Mirabegron Surveillance" study
510K's: K935380 K060341 ETC
INVAGEN PHARMACEUTICALS, HAUPPAUGE, NY - 483 04/02/2016 -
04/30/2016
HILL TOP RESEARCH, ST PETERSBURG, FL - EIR 05/03/2017 -
05/15/2017
LRM PACKAGING, SOUTH HACKENSACK, NJ - EIR
THEM PACKAGING, MARLTON, NJ - EIR 10/01/2015 - 10/01/2017
FDA EXPORT CERTIFICATES PRODUCTS EXPORTED TO IRAQ
FOS for Beuthanasia D NADA # 119-807
K802146
YESCARTA BLA CORR, RECS
ACTIENT, AUXILIUM, ENDO, RYE, NY - EIR 01/29/2016 - 10/27/2017

HAACP INSPECTIONS RECS FOR FRESH TUNA, BOB GOSMAN, CO
01/01/2007 - 10/22/2017
LENALIDOMIDE AERS
OCREVUS AERS
ITG BRANDS, LLC SANTA FE NATTURAL TOBACCO COMPANY, SHERMAN'S
1400 BROADWAY NYC LIMITED RECS RE WARNING LETTERS 06/01/2015 -
10/27/2017
Food Contact Notification 1761
JAMES HERMEX, DBA MOE'S ROE, GARDEN, MI - HACCP PLANS,
INSPECTIONS, ETC 11/01/2012 - 01/31/2014
RECS RE CANNABIDIOL, CBD AS DIETARY SUPPLEMENT, ETC 01/01/2015
- 10/27/2017
BEVESPI AEROSPHERE, STIOLTO RESPIMAT, UTIBRON NEOHALTER ETC -
PRECLINICAL PHARMACOLOGY AND TOXICOLOGY STUDIES
K170082
RECS RE TESTING OF POWDERED INFANT FORMULA MED JOHNSON ZEELAND,
MI CRONOBACTER SAKAZAKII 08/01/2017 - 10/27/2017
MEDTRONIC, EATONTOWN, NJ - EIR 2013
NDA 209022 XHANCE
K171120
RPT1013 RPT996
LOPERAMIDE AERS
KITE PHARMA, EL SEGUNDO, CA - EIR 04/29/2017 - 10/29/2017
SORIN GROUP DEUTSCHLAND GMBH - STOCKERT HEATER COOLER SYS LIVA
NOVA PLC - RECS 1/15 TO PRESENT
DAPTOMYCIN NDA 08-385 SBA
INDUCTION FOR THE FDA BLUEPRINT FOR PRESCRIBER EDUCATION FOR
EXTENDED RELEASE & LONG ACTING OPIOD ANALGESICS (CERTIFIED)
2013
PHARMACIA & UPJOHN CO - CLEOCIN T N050615 TEDOR PHARMA INC -
CLEOCIN T N050600 - MED RVW, CHEMISTRY RVW, LBLG
AMIODARONE IICI - LBLG 3/1/12
ELMIRON NDA 20-193 SBA
ZOLOF - AER
CTP1300318, CTP1300432
APTAR STELMI SAS - 483 1/14 TO PRESENT
2017-759, 2017-243, 2017 LOG
CORR BETWEEN FDA & OMEROS CORP
GLAXO OPERATIONS UK LTD, BARNARD CASTLE, UK IBI ISITUTO
BIOCHIMICO ITILIANO GIOVANNI LORENZINI, APRILLA, ITALY
TATEYAMA KASEI CO LTD, IMIZU, JAPAN - 483 7/1-31/17
BIOMET UK LTD, BRIDGEND, UK TELEMED, VILNIUS, LITHUANIA
BURNSHIELD PTY LTD, GERMISTON, SOUTH AFRICA - 483 8/1-21/17
JIANGSU YONGAN OHARMACEUTICAL CO LTD, HUAIAN, CHINA DOTTIKON
EXCLUSIVE SYNTHESIS AG, DOTTIKON, SWITZERLAND YICHENG CHEMICAL
CORP, CHANGZHOU, CHINA - 483 7/1-31/17
WE GOT NUTTS LAB RESULTS 01/30/2017 - 10/30/2017
Docket No. 80N-0042
SAGE COMFORT CLEANSING WASHCLOTHS RECALL RECS 09/01/2016 -
02/28/2017
K012044 FIRST PARTY
NDA 020193 SBA
NDA 016020
STEM CELL TRIAL RECS
NDA 020214 NDA 020551
CHARACTERIZATION OF SEQUENCE AND IMPURITY OF HP ACTHAR GEL
ANDA 090132
K160226
VMF 6113
DR EYTAN STEIN, MEMORIAL SLOAN KETTERING CANCER CENTER,
LEUKEMIA SERVICES, NEW YORK, NY ETC - 483, EIR MARCH 2017
EDWARDS LIFESCIENCES, SINGAPORE - EIR 07/10/2017 - 07/14/2017

13948587 13960237 13974349 ETC
MERIDIAN MEDICAL TECHNOLOGIES, INC, BRENTWOOD, MO BRENTWOOD
ANIMAL HEALTH, AUGUSTA, GA CIMBAR PERFORMANCE MINERALS,
CHATSWORTH, GA - 483 01/30/2017 - 03/31/2017
ACZONE APPROVAL RECS
Food Contact Notification (FCN) 1770
AZRA RAZA MD, NY - INSPECTIONS, INVESTIGATIONS ETC 10/01/1990 -
10/30/2017
FCN 1770
13583398 13620972 13646063 ETC
NDA 008975 CORR
NDA 0098554
GREEN CHILE'S TESTING RECS

DMF 4181 CORR
CORR NDA 008372
BEVESPI AEROSPHERE SBA
GARRY J RASER, DYNAMIC ESSENTIALS INC, LAKE MARY, FL -
INVESTIGATIONS RECS
2012-7550
IMPORT RECS
STERIS, QUEBEC, CANADA - EIR 6/17
HILL TOP RESEARCH, ST PETERSBURG, FL - EIR 5/17
CMPLNT 150951, OTHER ENFAMIL INCIDENTS
LOG 2012 - 2017
LOG 2015
IMPRIMIS PHARMACEUTICALS INC - SAMPLE 965775 8/14/17
POLICIES ON BRADED & GENERIC DRUG MANUFACTURERS DUTIES TO
UPDATE DRUG INSERTS, WARNING LBLB, PRECAUTIONS, RESPONSIBILTY
TO SEND WARNING LTRS, ETC
VACCINE - AER
BOHEMIAN MINERAL & CELERY NO 5835
HEALTH FACILITIES INC, WEST VIRGINIA - EIR, 483, WARINING LTRS
1/98 TO PRESENT
K170300
A list of all FOIA requests closed for 10/1-31/2017
EIRs for Merck, West Point, PA
Results of inspection of Southport Distribution in New Jersey
dated October 2015
EIRs for Novartis, East Hanover, NJ
K081656 K071328 K063505 etc
2012-3285
INSPECTION DATA 09/01/2017 - 10/31/2017
EIR, 483 etc for 06/2016 inspection of Merck, West Point, PA

THE MEDICINES COMPANY EIR 12/02/2016 - 12/31/2016
NDA 007707
K915417
EASTMAN CHEMICAL COMPANY, KINGSPORT, TN - EIR, 483, CAPA JULY
2016
INDIVIDUAL RECS
Clinical Study Report for TRIUMPH (CSR 04001) - Soliris
(eculizumab Alexion) PNH study including Listings 16.2.5.1.1
and 16.2.5.1 - BLA 125166
PREVIOUSLY RELEASED 483 10/01/2017 - 10/31/2017
PREVIOUSLY RELEASED EIR 10/01/2017 - 10/31/2017
COOK MEDICAL - ENTUIT SECURE ADJUSTABLE CASTROINTESTINAL SUTURE

ANCHOR SET FDA GUIDELINES, INSTRUCTIONS, APRVL RECS, ETC
STAAR SURGICAL CO - RESP TO WARNING LTR 5/21/14
NDA 204-412/S006 - SBA
PHILIP MORRIS - APPLICATION FOR MODIFIED RISH ORDER FDA
COMPREHENSIVE ROADMAP TO NICOTINE AND TOBACCO
HEALTH FACILITIES INC, WV - EIRS, 483S, WARNING LTRS 1/1/98
NOOTROPIL, BREINOX, DINAGEN, ETC - EMAILS, MEMOS, WHITE PAPERS,
ETC 1/1/03 TO 8/15/17
COLURACETAM - WHITE PAPERS, EMAILS, NEW DIETARY INGREDIENT
NOTIFICATIONS, ETC 1/1/12 TO 8/15/17
NUTRISYSTEM - COMM WITH REPRESENTATIVES OF THE COMPANY 1/1/15
TO 10/30/17
HAMPTON CREEK INC - CORR 6/20/17-8/21/17
BRIAN WAINSTEIN, AXIO LABS, GENXL - INVESTIGATION RECS
DIETARY SUPPLEMENTS - CAERS 1/1/10 TO PRESENT
ANDROGEN RECEPTOR MODULATORS - CAERS 1/1/08 TO 10/31/17
KRATOM - NEW DIETARY INGREDIENT NOTIFICATIONS 3/21/17-10/30/17

CMPLNTS FILED BY DIETARY SUPPLEMENT OR PHARMACEUTICAL COMPANIES
AGAINST OTHER COMPANIES FOR SELLING SELECTIVE ANDROGEN RECEPTOR
MODULATORS 1/1/31/15 TO 10/31/17
CMPLNTS FILED BY CONSUMERS OF DIETARY SUPPLEMENTS AGAINST ANY
OTHER COMPANY FOR SELLING SELECTIVE ANDROGEN RECEPTOR
MODULATORS 1/15 TO 10/17
EPIPEN RECS 01/01/2012 - 11/02/2017
K112955
K984058 K040298 K051799 ETC
MPI, MATAWAN, MI - 483, EIR 01/01/2010 - 11/01/2017
K150462
SHENZHEN ORIENTAL PHARMACECUTICAL CO LTD - EIR 06/01/2016 -
10/07/2016
LOG OF CORR FDA AND REP DAN DONOVAN 05/12/2015 - 11/01/2017
CTP Reviewer Guides for substantial equivalence reports
K083153
NUPLAZID AERS
MITSUYA MORITA, MD, JAPAN - EIR, 483 01/16/2017 - 11/01/2017

NDA 11287/S26
RECS RE WHETHER DECELLULARIZED DERMIS IS SUBJECT OR REGULATION
AS HUMAN CELL, TISSUE, AND CELLULAR AND TISSUE BASED PRODUCTS
ETC
RECS RE WHETHER CRYOPRESERVED VEINS OR ARTERIES ARE SUBJECT TO
REGULATION AS HUMAN CELLS, TISSUES AND CELLULAR AND TISSUE-
BASED PRODUCTS ETC
ORANGE BOOK CUMULATIVE SUPPLEMENT
FORM 483 LAST TEN YEARS 11/01/2007 - 11/01/2017
Request for Pre-Market Notification of US Botanicals for S-

adenosylmethionine (SAMe) (synthesized from methionine and
adenosine triphosphate) - Report 19 as Dietary Supplement and
any other related information
MEWATCH 13406446, 13456118, 13456244, ETC
CHEMISTRY MEMO FCN 971
ANDA 205878 SBA
FDA-2002-E-0121 FDA-1996-E-0366 FDA-1985-E-0285 ETC
OCALIVA FAERS
K940422
K092283
K152055
NDA 012462
HHSF22301001T HHSF223200950007I
ABBOTT LABORATORIES FOIA LOG 10/17/2017 - 10/30/2017
AMANTADINE AERS
K172414
NDA 007335 LABELING RECS
FIRST PRIORITY INC, ELGIN, IL - EIR 04/19/2017 - 04/25/2017
SIEMENS MEDICAL SOLUTIONS USA, INC - RF-OPAQUE BLANKET FOR
MAGNETOM SYS K913869
AstraZeneca LP - PRILOSEC (0MEPERAZOLE), NEXIUM (ESOMEPRAZOLE)
AERS
TAKEDA PHARMACEUTICAL COMPANY LTD - PREVACID (LANSOPRAZOLE),

DEXILANT (DEXLANSOPRAZOLE) AERS, CORR, WARNINGS, ETC
VASCEPA - NDA 202-507 UNREDACTED APRVL RECS
ZYPREXA - LBLG, RECS
DEEP VENOUS TEHEROMBOSIS & PULMONARY EMBOLISM IN USERS OF
TESTOSTERONE REPLACEMENT THERAPY PRODUCTS
PURDUE PHARMA LP - OXYCONTIN (OXYCODONE HCL) ER NDA 20-553
ADVERTISING, PROMOTIONAL, EDUCATIONAL RECS
FOOD CONTAMINANT, INGREDIENT FOOD SCIENCE AND RESEARCH, ANIMAL
HEALTH, HEALTH STUDIES, ETC PERTAINING TO THE PRESENCE,
OCCURRENCE, AND USE OF PERFLUROCTANOIC ACID IN ANY PRODS,
ANIMALS, FOOD, DRUGS 1/1/2007 TO 11/1/2017
FRESENIUS - KABI PLUS AUTO TRANSFUSION MEDICAL DVC SYS
EPIPEN RECS RELEASED TO BLOOMBERG NEWS 11/2/2017
CELGENE CORP - ORPHAN DRUG DESIGNATION FOR LENALIDOMIDE
REVLIMID (REVIMID) APPL RECS, CORR, ASSESMENT/RVW, ETC 2001 TO
2006
2017-2915
ENTRY #D0108554128 - NOTICES FOR REQUEST OF INFORMATION (CF28)
FDA NOTICE OF ACTION CBP REDELIVER NOTICES (CF-4647)
PET TREATS/CHEWS (DRIED CHICKEN MEATS WRAPS BOVINE
SKIN/RAWHIDE) - ENTRY HH7-0310260-3 PET TREATS/CHEWS(DRIED
CHICKEN BRAST STRIPS) - ENTRY HH7-0310225-6 RECS
ANDA 209019
IRESEARCH TRIANGLE INSTITUTE HHSF223201400007I EASTERN
RESEARCH GROUP, INC. HHSF223201400008I
PIRAMEL PHARMA SOLUTIONS, LEETCXINGTON, KY - EIR, 483, WARNING
LETTER
SAFC, ST LOUIS, MO - EIR, 483, WARNING LETTER ETC 11/01/2012 -
11/01/2017
K081509 K090240 K120561 UNREDACTED
ANTHEM BIOSCIENCES, INDIA - EIR, 483, WARNING LETTER ETC
11/01/2012 - 11/01/2017
SHERPA CLINICAL PACKAGING, SAN DIEGO, CA - EIR, 483, WARNING
LETTER ETC 11/01/2012 - 11/01/2017
ANDA 209018
VACUNDA & DESIGN CORR WITH FDA RE WARNING LETTER
K081509 K090240 K120561 UNREDACTED
Z-2618-2010 RECS
DIVI'S LABS UNIT II 482, 145 LETTER DEC 2016
Z-2619-2010
K110732
REPRO-MED PRODUCTS, CHESTER, NY - EIR 06/03/2015 - 12/17/2016

C.H. Robinson Worldwide PRIOR NOTICE RECS
SUPERIOR FISH GUYS, CANADA - INSPECTION RECS, CORR, ETC
11/01/2012 - 01/31/2014
ACCELERATED ANALYTICAL LABORATORIES, INC, MILWAUKEE, WI - EIR,
483, CORR 05/08/2017 - 05/12/2017
DHF or Design History File for Conceptus Inc and Bayers Essure
sterilization device
CORR RE CELLIANT HOLOGENIC LLC
BLA 103782 BLA103941
NDA 016990 SBA
FOIA daily log 9/1/17 - 11/3/17
ISOMETHEPTENE MUCATE - APRVL LTR 1948, LBLG, ANNUAL RPTS
LIVANOVA PLC - STOCKERT 3T HEATER-COOLER DVCS LAB STUDIES 2015
TO PRESENT INDIVIDUAL RECS
CPT1700068
AMERISOURCEBERGEN, MCKESSON, CARDINAL HEALTH - STATISTICS,
RPTS, DATA SETS, ETC SUPPLIED TO THE DEA 2007 TO PRESENT
OPANA EXTENDED RELEASE (ER) - APRVL AND DENIAL RECS
EPIPEN, EPIPEN JR FOIA REQUEST 01/01/2012 - 11/03/2017
BAKERY BARN, INC, PITTSBURGH, PA - EIR 11/01/2014 - 11/01/2017

SIMON BEHAR MED RED UNLIMITED, MIAMI, FL - 483 04/01/2008 -
11/03/2017
NUPLAZID AERS
LONG ISLAND RADIOLOGY - VIOLATION OF MAMMOGRAM QUALITY STANDARD
ACT 01/01/2000 - 10/31/2017
FEDERAL MEDICAL DEVICE REPORTING REGS 01/01/1983 - 04/11/1996

2017-4261, 2017-5615, 2017-6618, 2017-7197, 2017-8382, 2017-
8605,2017-8614, 2017-8711
RECS RE KELLOGS INVESTIGATION
RECS RE INVESTIGATION OF EXPLOSION AT CORBION, GRANDVIEW, MO
03/10/2015 - 12/31/2015
K163474
SUN PHARMA, DADRA, INDIA DIVIS LABS, UNIT 2, BIOCON, BANGALORE
- EIR 10/01/2017 - 11/06/2017
LENNY & LARRY'S INC, LOS ANGELES, CA - 483 MOST RECENT
K122801
FCN 1349, 100, 71, 592, 462
ENDOCHOICE, ALPHARETTA, GA - EIR 12/16
CLEANLINESS CMPLNTS AT FLORIDA STATE PRISON
PIPELINE FLEX PREMARKET APRVL P100018
FDA-ORA-17-MP-19995620-MK RECS
INTERSECT ENT INC, MENLO PK, CA - 483 7/17 TO PRESENT
CMPLNT 149495
APTALIS PHARMA US, BIRMINGHAM, AL - EIR, 483, CORR 8/29/13
ELITECH GROUP, LOGAN, UT - EIR, 483, CORR 5/27/15
CADENCE SCIENCE, CRANSTON, RI - EIR, 483, CORR 1/25/17
ROSWELL PARK CANCER INSTITUTE, BUFFALO, NY EIR, 483, CORR
1/23/14
ZYNO MEDICAL, NATICK, MA - EIR, 483, CORR 8/11/16
SELF REPORTED FLAVOR STATUS FOR ALL VARIETIES OF BLACK & MILD
JAZZ
FLOWERS BAKING COMPANY OF THOMASVILLE, INC, - WARNING LETTER,
RESPONSE, EIR, ETC 01/01/2003 - 12/31/2004
PATENT DATA ETC
FRAMEWORK THERAPEUTICS LLC SODIUM ALUMINOSILICATE ORPHAN
DESIGNATION RECS
RECS RE JUST FOR MEN PRODUCTS CAERS, CORRECTIVE ACTIONS
RECS RE FOOD INTEGRITY IMPORTED FROM CANADA, INVESTIGATION
RECS, MAPLE SYRUP 11/05/2007 - 11/06/2017
ANGELINI PHARMA, GAITHERSBURG, MD - EIR, 483, CORR 3/17/15
Package Insert, container labels, and drug listings for
Atabrine, Atebrin or quinacrine 2HCl
SPARHAWK LABORATORIES, INC CONSENT DECREE
FDA-2011-N-0513 LETTER TO JANE AXELRAD
NEMECEK, ENEIDA, MD, PORTLAND, OR - EIR, 483, CORR 04/05/2017
- 04/14/2017
YANIK, GREGORY, MD, ANN ARBOR, MI - EIR, 483, CORR 04/03/2017
- 04/11/2017
MYRON LEVIN, MD, AURORA, CO - EIR, 483, CORR 04/05/2017 -
04/21/2017
PRAXAIR DISTRIBUTION, DETROIT, MI - EIR, 483, CORR 1/12/17
KIERON DUNLEAVY, BETHESDA, MD - EIR, 483, CORR 10/3/16
K161642
GILEAD SCIENCES, FOSTER CITY, CA - EIR, 483, CORR 10/9/13
BRIGHAM AND WOMEN'S HOSPITAL, BOSTON, MA - EIR, 483, CORR
8/15/14
FCN 1507, 1390, 1184, ETC
NDA 012462
ANDA 085762
ANDA 040357
DSM PHARMACEUTICALS GREENVILLE, NC - EIR 07/05/2007
PFIZER, GROTON, CT - 483 9/22/17
K102567 K161579
Copies of 483s issued by CDER's International Operations office

APPROVAL LETTERS NDA 021146 SUPPL-17 SUPPL-18
RECALL DATA
Roche Athena Protocol for HPV BD HPV Protocol #BDS-USHPV for
Study Protocol for HPV-GT Viper Assay
INSPECTIONS CLASSIFICATION SPREADSHEET
DRUG MASTER FILED SPREADSHEET
METHOCANBOMOL, ORPHENADRINE, SALOCYCLAMIDE PENTAZOCINE,
CORISOPRODOL, MEPROBAMATE - APRVL
MEDICAL IMAGING DRUGS ADVISORY MTG 9/8/17
INDIVIDUAL RECS
CORR WITH IBM CORP RE WATSON HEALTH PRODUCTS BETWEEN 1/14 TO
10/21/17
ATTACHED DOCUMENT RED RIBBON CERTIFIED
STEMIMMUNE, SAN DIEGO, CA - EIR, 483, CORR 8/4/17
RECS RE FULL COMPLIANCE WITH EO 13771 04/01/2017 - 11/06/2017

RECS RE MERCURY POISONING LINKED TO SKIN PRODUCTS 3/12 ETC
DRG INSTRUMENTS, GERMANY - 483 10/24/2016 - 10/28/2016
FIRSON CO, LTD, KOREA - 483 11/03/2016 - 11/11/2016
MYLAN LABORATORIES, INDIA - 483 09/05/2016 - 09/14/2016
RECS RE FLUOROQUINOLONE ANTIBIOTICS 01/01/2014 - 11/06/2017
REFERENCES CITED IN 28 Fed. Reg. 2850
RECS RE CHANGES TO SAFETY INFORMATION ON THE LABELS OF STATINS
01/01/2012 - 05/26/2012
VADASTAXIMAB TALIRINE AERS
KETOTIFEN FUMARATE AERS
2002-9017
2002-10749
2002-9245
2002-11900
2002-12010
2002-13184
2002-13189
2002-13324
2002-13716
2004-13760
NDA 20645
DKT 2004N-0050
RECS RE MEETING WITH NSPIRE, HAIN CELESTIAL RE SALMONELLA
ALMOND BUTTER RECALL 06/06/2013 - 12/30/2015
LUPIN WARNING LETTER 11/05/2017 - 11/07/2017
CHARTER OF FDA
LUPIN WARNING LETTER 11/06/2017
FOIA LOG ABBOTT, ABBOTT LABS, ABBOTT LABORATORIES 10/01/2017 -
10/31/2017
WILLIAM C DOMB, DMD, UPLAND, CA - EIR, 483, CORR 09/18/2014 -
10/16/2014
K163586
LUPIN, LTD, GOA, INDORE - WARNING LETTER, 483
2017-8568
B BRAUN MEDICCAL, INC, IRVINE, CA ALLENTOWN, PA BAXTER
HEALTHCARE, MARION INC ETC - EIR
NDA 207103, S-004
K162466
K161768
NDA 011522
INCIDENT REPORT RECS
K101995 K152258
MERIDIAN MEDICAL TECHNOLOGIES, MO - 483 02/01/2017 - 11/07/2017

K170330
NDA 019897
INDIVIDUAL RECS 01/05/2015 - 11/06/2017
NDA 209501
SUN PHARMACEUTICAL INDUSTRIES LIMITED, DADRA, INDIA
03/01/2017 - 10/28/2017
ANDA 206391 ANDA 203693
2017-8773
CPT 1700386
FOI DAILY LOG 9-25-29-17
CLOSED FOI REQUESTS 9-25-29-17
FAERS REPORTS REFERENCED IN ARTICLE BY CARMEN CHANG
FDA-1987-P-0172 NITROPRESS APPROVAL LETTER
LIST OF 483S
HATFIELD QUALITY MEATS, HATFIELD, PA - INSPECTION RECS
01/01/2015 - 01/01/2017
FDA-2011-N-0513
MEETING RECS, CORR RE PROPOSED RULE TO REVOKE HEALTH CLAIM THAT
SOY PROTEIN REDUCES RISK OF HEART DISEASE
DELTA SYNTHETIC CO LTD, TW SIEGFRIED EVIONNAZ, CH - EIR
11/01/2014 - 10/29/2017
ARDENT MILLS, LLC, ALBANY, NY - EIR 10/19/2016 - 11/10/2017
COVANCE, CHANTILLY, VA - 483 01/01/2015 - 01/01/2017
RICHARD STONE, BOSTON, MA - EIR 01/02/2017 - 11/03/2017
DEN150028
SBA NDA 019787 NDA 019488 NDA 019810
BLA 125514/S-14
LUPIN LTD, GOA, INDIA - WARNING LETTER 11/06/2017 - 11/06/2017

ADVANCE PHARMACEUTICAL INC, HOLTSVILLE, NY NEW YORK BLOOD
CENTER, LONG ISLAND CITY, NY CIRCULATORY TECHNOLOGY INC,
OYSTER BAY, NY - 483 03/09/2010 - 09/29/2017
DIOCTO LIQUID SAMPLES, ADVERSE EVENTS 01/02/2017 - 11/08/2017

14038121 13964379 14011926 ETC
13998937 13909302 13863067 ETC
K170597
CHARLES RANDALL, MD, SAN ANTONIO, TX - EIR, 483, CORR
07/24/2015 - 08/18/2015
WEST-WARD PHARMACEUTICALS CORP - RECS, CORR RELATED TO 2/3/12
WARNING LTR
MULTISTATE OUTBREAK OF SHIGA TOXIN PRODUCING ESCHERICHIA COLI
IM HEALTH BRAND SOY NUT BUTTER 12/01/2016 - 11/06/2017
BLA 125031 / S-180
TALC RECS 01/01/1970 - 01/01/1990

CLINICAL TRIAL RECS
NDA 50416 NDA 50417
LYNPARZA, ZEJULA, NIRAPARIB ETC AERS
INDIVIDUAL RECS
K933717
Summary basis of approval for NDA 016087
2017-3663
K081960, K143630, K163689
2017-3465
JOEL BLOCK, MD, RUSH PRESBY ST LUKES MED CTR, CHICAGO, IL - 483
07/01/2001 - 11/30/2001
K162640
FCN 1789
ANDA 204052 APPROVAL LETTER, LABELING
ANDA 202605 APPROVAL LETTER, LABELING
FRESENIUS KABI USA - BORTEZOMIB NDA 205-004 SBA
K143033
2017-5861
2016-8577
2017-3506
2017-3812
FDA FOIA LOG ST JUDE MEDICAL
INDIVIDUAL RECS
MYLAN, CATALENT PHARMA - AMNESTEEM WARNINGS, CITATIONS, CO
RESPS 2002 TO 2014
GO LYTLELY NDA 19-001/S025 NULYTELY NDA 19-797 - AERS, LBLG,
WARNINGS, ETC
DURAGESIC FENTANYL TRANSDERMAL PATCH - WANRINNGS 6/21/13,
PUBLIC HEALTH ADVISORY, DRUG SAFETY PODAST, ETC
ZIMMER INC, SIMMER BIOMET INC - M/L TAPER PROSTHESIS K060040
MDRS, INVESTIGATIONS, RECALLS, ETC 2006 TO PRESENT
FRESENIUS KABI USA - BORTEZOMIB NDA 205-004 APRVL LTR 11/6/17

CHIPOTLE - FOOD SAFETY VIOLATIONS, FOOD-BORNE OUTBREAKS LTRS,
EMAILS, MEMOS, ETC 1/16 TO PRESENT
NEW INFANT FORMULA NOTIFICATIONS - STUDIES, RPTS, WITHDRAWAL,
ETC 2/10/14 TO PRESENT
WILLIAM SNELSON, THERESA WEITZEL RUSSELL, JOHN BOLEN -
REFERENCES, QUESTIONS
RECS RE THE RELIANCE ON THE INTERNATIONAL COUNCIL FOR

HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR
HUMAN USE GUIDELINES RELATED TO REGULATORY ENFORCEMENT
DECISIONS FOR FOOD RECS RE TOLUENE AND RESIDUAL SOLVENT IN
FOOD ETC
ARKRAY INC, JAPAN - EIR MAY 2016
Copy of the disclosable portions of the Technical Lead Reports
and decision summaries for the three Exemption from Substantial
Equivalence Final Orders issued in August 2017
COMMUNICATIONS BETWEEN FDA AND TEVA PHARMACEUTICALS RE ANDA
071523, LABELING ETC 01/01/2008 - 12/31/2013
manufacturers and importers of tobacco products for which a

user fee was received during the fourth quarter of fiscal year
2017, and (2) any and all of the manufacturers and importers of
tobacco products for which a user fee was assessed during the
fou
FSIS RECS
Monthly District 483 Requests
Technical Project Lead Reports and decision summaries for all

Non-Substantial Equivalence (NSE) Orders issued in the
following months: October 2016, December 2016, February 2017,
March 2017, April 2017, May 2017, July 2017, and August 2017
RECS CONSIDERATION OF OR RELIANCE UPON THE INTERNATIONAL

COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR
PHARMACEUTICALS FOR HUMAN USE GUIDELINES FOR DIETARY
SUPPLEMENTS RECS RE LEVELS OF TOLUENE AS A RESIDUAL SOLVENT IN
DIETARY SUPPLEMENTS ETC
PACIFIC NATURALS WARNING LETTER 04/27/2011 - 04/28/2011
Copy of the disclosable portions of the Technical Project Lead

Reports and decision summaries for all of the Substantial
Equivalence (SE) Orders issued in June 2017 and August 2017
1R13FD006142-01
GRAS notice documents for Rheolex LM and/or glucomannan
manufactured by Shimizu Chemical Corporation ETC
K932786
TRULICITY, TALTZ, ADCIRCA ETC AERS
K173298
CLINOGENT, INDIA - 483 2009
BLUE APRON, LINDEN, NJ - INSPECTIONS ETC 01/01/2011 -
11/10/2017
K140849
WL GORE AND ASSOCIATES, FLAGSTAFF, AZ SANTA CLARA, CA - EIR
04/11/2016 - 05/31/2017
K911101
P110033
NDA 20648
K124043
Case Number 5787006 Hydrocodone/APAP (Vicodin) Adverse Drug
Event report
NDA 208470 SBA
NDA 020908/S13 SBA
FDA-1988-E-0427 FDA-1986-E-0429 FDA-2006-E-0262 ETC
NDA 020216/S60
PHILIPS MEDICAL SYSTEMS, INC CLEVELAND, OH - 483
CORR BETWEEN COMMISSIONER SCOTT GOTTLIEB AND COMPANIES IN
PUERTO RICO 09/01/2017 - 11/10/2017
Case number 6045299 Adverse Drug Event report for Ocycodone

CORR BETWEEN SCOTT GOTTLIEB AND PHARMA-BIO 09/01/2017 -
11/10/2017
LIST OF APPROVED COMBINATION MEDICAL DEVICES 01/01/2017 -
11/10/2017
ALCHYMARS ICM, INDIA - 483 09/08/2017 - 11/16/2017
RECS RE CITIZEN PETITION GARY RUSKIN 04/09/2015 - 11/10/2017

K131681 K072254 K891008 ETC
ONYX BRANDS, ACETONE NAIL POLISH REMOVER - RPTS RE FIRE,
EXPLOSION 11/10/2002 - 11/10/2017
PREDICTIVE BIOTECH, INC, SALT LAKE CITY, UT - EIR, 483, NOTES
ETC 10/15/2017 - 11/13/2017
CHILCHOTA ALIMENTOS SA DE CV DWPE RECS 01/07/2008 - 09/18/2009

CHAMPLAIN VALLEY CREAMERY, MIDDLEBURY, VT CABOT CREAMERY CO-
CO, MONTPELIER, VT GRAFTON VILLAGE CHEESE CO, GRAFTON, VT ETC
- INSPECTION RECS LAST FIVE YEARS
ANDA 089586 SBA
JOHN M PAGEL, FRED HUTCHINSON CANCER RESEARCH CENTER EIR
09/28/2014 - 11/06/2014
JANA MEDICAL 510K 06/03/1992 - 08/01/1993
INDIVIDUAL RECS
GEORGE TAUB PRODUCTS & FUSION CO INC, JERSEY CITY, NJ -
INSPECTION RECS 04/03/2017 - 06/16/2017
ANDA 089804
ANDA 089743
ANDA 084114
K862912 K873356 K894477
K163142
BK080022
GLENMARK, BADDI, INDIA - 483 11/01/2017 - 11/13/2017
CALIFORNIA RANCH FOOD COMPANY, INC, VERNON, CA - 483 AMGEN,
THOUSAND OAKS, CA - 483 11/21/2016 - 05/16/2017
The Premarket Tobacco Product Application (PMTA) Reviewers
Guide The Substantial Equivalence for Tobacco Products (SE)
Reviewers Guide
Background Document for Meeting of Advisory Committee for
Reproductive Health and Drug Safety and Risk Management
Advisory Committee
PRILOSEC FAERS
COMMUNICATIONS RE FDA PROPOSAL TO REVOKE AUTHORIZATION OF THE

USE OF HEALTH CLAIMS ON THE RELATIONSHIP BETWEEN SOY PROTEIN
AND CORONARY HEART DISEASE ETC 01/01/2007 - 11/30/2017
BAXTER HEALTHCARE CORP, JAYUYA, PR EIR
B BRAUN MEDICAL INC, IRVINE, CA - EIR 11/13/2013 - 03/03/2015

K171392
REVLIMID, ESBRIET, JAKAFI, ETC FAERS
ASPIRE BARIATRICS INC, KING OF PRUSSIA, PA - EIR 08/10/2017 -
08/31/2017
INDIVIDUAL RECS
TWITTER ACCOUNTS BLOCKED BY FDA
2016-698
BALBOA CAFE MILL VALLEY, MILL VALLEY, CA - EIR
KRATOM - EVALUATION
CORR TO & FROM SCOTT GOTTLEIB REGARDNG KRATOM
PREDICTIVE BIOTECH, SALT LAKE CITY, UT - 483, EIR
TARO PHARMACEUTICALS - DAPSONE GEL ANDA 09-506 SBA
G & W LABORATORIES INC - INDOMETHACIN ANDA 73-314 SBA
CORR BETWEEN FDA & DOLE, CASTLE & COOKE - INVESTIGATION 1/00 TO
PRESENT
EXACTECH INC - OPTETRAK TOTAL KNEE SYS K932690, K932776,
K933494, ETC
ENTRY NO HH7-0310225-6 HH7-0310260-3
MOU CITED IN ANNUAL PESTICIDE RESIDUE TESTING RPT BY FDA
RESTICIDE VIOLATIONS 2012-2017
CHLORPROMAZINE HYDROCHLORIDE FEDERAL REGISTER DETERMINATION
THAT PRODUCT WAS NOT DISCONTINUED OR WITHDRAWN FOR SAFETY OR
EFFICACY REASONS
LIST OF FDA APPROVED STENTS 01/01/1980 - 11/13/2017
EMAIL, CORR, COMMUNICATION BETWEEN FDA AND ZIMMER BIOMET INC RE
483 ISSUED 11/22/16 08/01/2017 - 11/13/2017
NDA/BLA IMPOSED REQUIREMENT/COMMITMENT
CORR, COMMUNICATION BETWEEN FDA AND STARKEY LABORATORIES, INC,
STARKEY LABS INC, STARKEY LABORATORIES LLC, RE DEVICE
APPROVALS, DEVICE RECALLS 1/1/14 TO PRESENT
Records related to PFGE match or whole genome sequencing on
Listeria from 2012 to 2017
2016-2881, 2015-5755, 2015-1126
GENUS LIFESCIENCES INC, ALLENTOWN, PA - 483 09/25/2017 -
09/29/2017
FDA-2014-P-1302 FDA-2014-P-1400
HOSPIRA INC, MCPHERSON, KS - 483 10/01/2017 - 11/13/2017
GOLD COAST TRADING COMPANY, BRONX, NY - RECS RE CONFISCATION OF
ITEMS 10/03/2017 - 11/29/2017
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE SBA
DIXIE DEW, ERLANGER, KY - INSPECTION RECS 01/01/2017 -
11/10/2017
2015-418, 2015-417, 2014-4160
NDA 205004
SMITH & NEPHEW, ANDOVER, MA - EIR 11/08/2016 - 11/09/2016
TFH PUBLICATIONS, NEPTUNE, NJ - EIR 06/02/2017 - 07/31/2017
PRODUCT QUEST MANUFACTURING LLC, HOLLY HILL, FL - EIR
02/09/2015 - PRESENT
E-PHARMA TRENTO SPA, ITALY - 483 01/25/2017 - 01/27/2017
K112423
CPT1700360
K171004
FULVICIN P/G (ULTRAMICOSIZE GRISEOFULVIN) ANDA 61-996 FULVICIN
U/F (GRISEOFULVIN) ANDA 60-569
RTI BIOLOGICS INC, ALACHUA, FL - RECALLS, WARNINGS, VIOLATIONS,
ETC 2000 TO 2017
REP MIKE BOST - CONGRESSIONAL CORR 1/1/15 TO 11/13/17
IDE G010002 AND/OR IRB 4281 - MDRS FORM 3500A SUBMISSIONS FOR
ANY ZENITH BRAN PRODUCT, FLEXOR BRAND PRODUCT, ETC
BIOMET - MAGNUM MALLORY PRESS-FIT ACETABULAR COMPONENT AND
FEMORAL HEAD 58 MM MDRS, RECS
MYDAYIS NDA 22-063
P820088
KRATOM - AERS, CAERS, RISKS, ETC
OTTO BOCK HEALTHCARE LP, SALT LAKE CITY, UT - EIR 01/01/2015 -
11/14/2017
CPT 1701010
BAXTER HEALTHCARE CORP, MOUNTAIN HOME, AR - EIR 07/16/2010 -
08/14/2015
K080964
SWEDISH MATCH - CORR, EXHIBITS, ETC SWEDISH MATCH GENERAL SNUS
PRODUCTS
CVM, AAFCO CONTRACTS, GRANTS MEETING MINUTES RE PET FOOD LABEL
MODERNIZATION 01/01/2015 - 11/14/2017
K122432
K103767
NDA 21-023
RECS RE DEATHS ASSOCIATED WITH KRATOM 01/01/2010 - 11/14/2017

K103547
ADVERSE EVENTS KRATOM RELATED DEATHS 11/14/2001 - 11/14/2017

LUPIN LIMITED, INDIA - 483 04/07/2017 - 11/14/2017
PHILIPS, CLEVELAND, OH - 483 AUGUST 2017 05/01/2017 -
11/01/2017
CONSULTING AGREEMENTS BETWEEN FDA AND PHYSICIANS ON RETAINER
BASIS 11/01/2007 - 11/14/2017
ADVERSE EVENTS ALL DAY ENERGY GREENS

RECS RE PRIORITY REVIEW VOUCHERS NOT GRANTED 01/01/2008 -
11/15/2017
TORRENT PHARMA, INDIA - 483, LETTER 04/01/2017 - 11/02/2017
LIST OF HOSPITALS, MEDICAL FACILITIES THAT USED A LIVANOVA PLC
STOCKERT HEATER-COOLER DEVICE DURING OPEN HEART SURGERY
01/01/2012 - 11/15/2017
K171120
FCN 972
BAXTER HEALTHCARE CORPORATION, MARION, NC - EIR 08/31/2012 -
01/24/2014
ESSURE CAPA DOCUMENTATION 11/01/2007 - 11/01/2014
BAXTER HEALTHCARE CORPORATION, CLEVELAND, MS - EIR 03/06/2013
- 03/27/2015
CDER FOIA LOG 12/31/2016 - 10/31/2017
B. BRAUN MEDICAL INC, ALLENTOWN, PA 05/21/2009 - 09/21/2015

ANDA 086101
PANJIN HETIAN FOOD CO LTD - RECS RE IMPORT ALERT BROWN RICE
PROTEIN POWDER 01/01/2017 - 05/31/2017
NDA 208385
OXYCONTIN RELATIONSHIP WITH CEREBRAL HEMORRHAGE, HIKMA LIMITED,
GUIDELINES ETC 01/01/1982 - 11/15/2017
SPECIALTY ENZYMES AND BIOTECHNOLOGIES, CHINO, CA - EIR
11/04/2015 - 11/10/2017
11/15/2017
RTI SURGICAL INC, ALACHUA, FL - EIR, 483, CORR 4/28/17
OCTAPHARMA PLASMA INC, OMAHA, NE - EIR 03/23/2017 - 03/24/2017

ANDA 207218
K870027
IBRUTINIB AERS
MARTHA MCSALLY - CORR 1/3/15 TO PRESENT
BAUSCH & LOMB - CRYSTALENS ACCOMMODATING POSTERIOR CHAMBER
INTRAOCULAR LENS P030002 CORR, PRIOR REQUESTS, REVIEVER FILES,
ETC
ZIMMER INC, ZIMMER BIOMET HOLDINGS INC - M/L TAPER PROSTHESIS

K060040 M/L TAPER WITH KINECTIV TECHNOLOGY K081007, K071856
IMMOBILE STERILE AND IMMOBILE A/C/ STERILE K941940 - FORM 3881
INDICATION FOR USE (IFU)
ABON PHARMS - CLOFARABINE INJ ANDA 204-029 180-DAY EXCLUSIVITY

NIKKISO CO LTD - DBB-06 HEMODIALYSIS DELIVERY SYS K091978
NIKKISO CO LTD - DBB-06 HEMODIALYSIS SYS K152938
B BRAUN AVITUM AG - DIALOG WITH ADIMEA OPTION K083460
WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD - REVEX (NALMEFENE
HCL INJ) NDA 20-459 MOR
PRAXAIR INC, PRAXAIR DISTRUBITION INC, PRAXAIR HEALTHCARE
SERVICES INC - CMPLNTS 2016, 2017
483s issued by the Detroit District Office 09/01/2017 -
09/30/2017
483s issued by the CDRH International Operations Office
09/01/2017 - 09/30/2017
483s issued by the Chicago District Office 09/01/2017 -
09/30/2017
483s issued by the Cincinnati District Office 09/01/2017 -
09/30/2017
483s issued by the Dallas District Office 09/01/2017 -
09/30/2017
483s issued by the New Jersey District Office 09/01/2017 -
09/30/2017
483s issued by the Seattle District Office 09/01/2017 -
09/30/2017
483s issued by the New Orleans District Office 09/01/2017 -
09/30/2017
483s issued by the New York District Office 09/01/2017 -
09/30/2017
483s issued by the Baltimore District Office, 9/1-30/17
BK080042
483s issued by the CDER International Operations Office
LONZA, CAPSUGELS, COHASSET, MN GREENWOOD, SC BEND, OR ETC -
483 01/01/2017 - 11/14/2017
483s issued by the CDER International Operations Office, 9/1-
30/17
CATALENT WOODSTOCK, IL - 483
DAEWONG PHARMACEUTCIALS, KOREA - 482 09/01/2017 - 11/15/2017

NDA PLUMIAZ COMPLETE RESPONSE LETTER
RECS RE SAN BERNADINO NOTIONAL FOREST, NESTLE WATERS NORTH
AMERICA, ARROWHEAD
483s issued by the Denver District Office 09/01/2017 -
09/30/2017
PROSUN INTERNATIONAL LLC, SAINT PETERSBURG, FL - EIR, 483, CORR
8/01/2017 - 08/04/2017
FDA Drug Establishment Current Registration Database
Local sharing amounts that have been seized in the Food and
Drug Administration's participation in the Department of
Justice's Equitable Sharing Program
483s issued by the San Francisco District Office 09/01/2017 -
09/30/2017
GLE GESELLSCHAFT FUR LICHTTENSHNISCHE ERZUEGNISSE, BGERMANY -
483 07/25/2016 - 07/29/2016
483s issued by the Minneapolis District Office 09/01/2017 -
09/30/2017
K033590 K060183
483s issued by the Florida District Office 09/01/2017 -
09/30/2017
483s issued by the New England District Office 09/01/2017 -
09/30/2017
483s issued by the Los Angeles District Office 09/01/2017 -
09/30/2017
CHONGQING PHARMA RESEARCH INSTITUTE CO. LTD, CHINA - 483
05/16/2016 - 05/19/2016
483s issued by the Philadelphia District Office 09/01/2017 -
09/30/2017
VISTA PHARMACEUTICALS LIMITED, INDIA - 483 09/19/2016 -
09/23/2016
SE0014067
NDA 208552
ANDA 085372 SBA
FAERS 14016890 13557584 13557248 ETC
K083292
NDA 019194
P060028 / PAS004
NDA 12373 REPORT
NDA 012283
VIBERZI AERS
K152033 K153754
BAXTER PHARMACEUTICALS SOLUTIONS, LLC, BLOOMINGTON, IN - 483

NDA 020908/S13 SBA
QIDONG DONGYUE PHARMACEUTICAL CO LTD, CHINA - EIR 03/21/2016 -
06/20/2016
WUXI APPTEC, SHANGHAI - 483 01/01/2017 - 02/28/2017
OFFICE OF COMMISSIONER CORR WITH ALEX AZAR 01/01/1996 -
08/31/2001
Certified copies of communications enclosing a FDA Notice to
PTH IND Holders dated on or about December 11, 1998, and
accompanying Information for Holders of INDs for PTH Products
FOIA REQUEST LETTERS GRANTED 01/01/2015 - 01/01/2017
INDIVIDUAL RECS
ACUTE HEPATITIS AND LIVER FAILURE FOLLOWING THE USE OF A

DIETARY SUPPLEMENT INTENDED FOR WEIGHT LOSS OR MUSICLE BUILDING
CLW FOODS INC - SALMONELLA, LISTERIA MONOCYTOGENES, LISTERIA

SPP CONTAMINANTS CORR, RECALLS, ETC 2013 TO PRESENT
PROPORTION FOODS LLC - SALMONELLA, LISTERIA MONOCYTOGENES,
LISTERIA SPP CONTAMINATS CORR, RECALLS, FINDINGS OF FOREIGH
OBJECTS IN FINISHED PRODUCTS, ETC 2013 TO PRESENT
DEXILANT, PREVACID - AERS 1989 TO PRESENT
RED CHAMBER CO, STANFORD COLD STORAGE INC, ORIENT FISHERIES,

ETC - VIOLATIONS, INVESTIGATIONS, CITATIONS 1/00 TO PRESENT
KRATOM - STUDIES
NDA 018831
K162513 K163253 K171544
CW170012
CORRECTIVE ACTION RESPONSE LETTER RE 483 DEPUY ORTHOPAEDICS
INC, WARSAW, IN 08/01/2017 - 11/17/2017
483s issued by Atlanta DO 10/01/2017 - 10/31/2017
483s issued by the Baltimore DO 10/01/2017 - 10/31/2017
483s issued by the Chicago DO
483s issued by the Cincinnati DO 10/01/2017 - 10/31/2017
483s issued by the Los Angeles DO 10/01/2017 - 10/31/2017
483s issued by the Dallas DO 10/01/2017 - 10/31/2017
483s issued by the Denver DO 10/01/2017 - 10/31/2017
483s issued by the Kansas City DO 10/01/2017 - 10/31/2017
483s issued by the Minneapolis DO 10/01/2017 - 10/31/2017
483s issued by the New England DO 10/01/2017 - 10/31/2017
AMERICAN SPECIALTY PHARMACHY DBA ASP BARES - EIR
P120005/S041
ACE ENDICO, BREWSTER, NY - EIR EXHIBITS, ATTACHMENTS 09/28/2017
- 10/20/2017
ANDERSONBRECON INC, ROCKFORD, IL - INSPECTION REPORT
03/20/2017 - 03/24/2017
K172604 CW170012
CW170004
NDA 009149 LABELING
NEXIUM FAERS
DEXILANT FAERS
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED - EIR
03/14/2016 - 03/31/2017
483 issued by the New Jersey DO 10/01/2017 - 10/31/2017
483s issued by the New Orleans DO 10/01/2017 - 10/31/2017
483s issued to the New York DO 10/01/2017 - 10/31/2017
483s issued by the Seattle DO 10/01/2017 - 10/31/2017
483s issued by the San Francisco DO 10/01/2017 - 10/31/2017
483s issued by the CDRH International Operations Office
10/01/2017 - 10/31/2017
483s issued by the CDER International Operations Office --
Simple Queue 10/01/2017 - 10/31/2017
483s issued by the CDER International Operations Office --
Complex Queue 09/01/2017 - 09/30/2017
K963816 K963817K971873 ETC
K093204, K100213, K101267, ETC
NDA 018485 LABELING
2017-8736 - REQUEST LETTER ONLY
2017-8545
2017-8615
2017-8587
2017-8691
CPT1700693
FDA CORR WITH FTC RE LEGITSCRIPT 01/01/2007 - 11/15/2017
2010-8225, 2010-8985, 2011-1138 ETC
HHSF223201300481A
NDA 019436 LABELING
NDA 007335 LABELING
PHILIPS SONICARE POWERUP TOOTHBRUSH RECS 01/01/1980 -
11/17/2017
REFUSE TO FILE LETTERS, COMPLETE RESPONSE LETTERS
NDA 016727 LABELING
NDA 010742 LABELING
9337961 9496351 9635984 ETC
PARK AVENUE STEM CELL THERAPY, NY, NY - INVESTIGATION RECS
10/12/2017 - 11/17/2017
INVAGEN PHARMACEUTICALS, CENTRAL ISLIP, NY - 483 05/01/2017 -
05/31/2017
REPORTS RE 36 KRATOM DEATHS 11/16/2000 - 11/16/2017
DAVID LORTSCHER, MD, SAN DIEGO, CA - INSPECTION RECS 09/01/2016
- 11/19/2017
SUN PHARMACEUTICALS, BASKA, INDIA - 483 11/01/2017 - 11/19/2017

8 ANDA approval letters
2002-13829
2003-2759
2002-16736
200214687
200215074
2002-16299
2002-16721
2003-806
2003-2547
2003-2347
Epipen FOIA requests
ENZYME TECHNICAL ASSOCIATION SUBMISSION TO FDA ON ANTIFOAMS AND
FLOCCULANTS 4/10/98
FOIA DAILY LOG 1/1/12 TO 8/1/12
P820088
MARGUERITE M KOHLHEPP MD, SUNCOAST EYE CENTER - MEDICAL HEALTH

ALERTS, EMAILS AVASTIN - MEDWATCH WARNINGS 2011, ETC
INDIVIDUAL RECS
MERIDIAN MEDICAL, BRENTWOOD, MO - EIR
AMG 785 APPROVAL RECS
NDA 208645
DEXLANSOPRAZOLE, LANSOPRAZOLE, OMEPRAZOLE, ETC - AERS 1989 TO
PRESENT
NDA 209191
APRIOMED, LONDONBERRY, NH SWEDEN - EIR 06/14/2017 - 11/20/2017

NDA 018057
STELARA (USTEKINIMAB) BLA 761044 - RVWS, APRVL RECS
ANICARE PHARMACEUTICALS PRIVATE LIMITED, INDIA - 483 MOST
RECENT
TOKUHOM CORPORATION, JAPAN - 483 11/01/2016 - 11/30/2016
OHTA, ISAN, JAPAN - 483 10/01/2016 - 10/31/2016
NDA 208385
ANDA 075547
ANDA 206936
ANDA 091646
ALTRIA - SUBSTANTIAL EQUIVALENCE FOR STN SE0012340, SE0012344,
SE0012346
SUMITOMO DAINIPPON, OITA, JAPAN - 483 02/01/2017 - 02/28/2017

TRYCINALONE ACTONIDE - AERS, MEDICAL CONDITIONS, EXTENDED USE,
ETC
ALKEM, BADDI, INDIA - 483 09/01/2017 - 11/20/2017
SCUTELLARIA BAICALENSIS AND ACACIA CATECHU (SENEGALIA CATECHU)
- AERS, CAERS
RECS RE CMS 495212 08/14/2016 - 05/15/2017
CPT1700445
CPT1700446
K150682
NDA 019966
CPT1700448
CPT1700447
K173305
COMMUNICATIONS BETWEEN FDA AND CELGENE CORP RE GED-0301
BLUEGRASS DAIRY AND GOODS, INC, GLASGOW, KY - EIR 11/02/2016 -
11/20/2017
K170210
DR REDDY'S LABORATORIES FORMULATION MANUFACTURING, DUVVADA,
INDIA - 483 11/15/2017 - 11/21/2017
K160364
ANDA 091640
K052659 K063204 K111010
NDA 21248
MEETING MINUTES SCOTT GOTTLIEB AND AMERICAN DIABETES
ASSOCIATION 10/30/2017
GELATIN CAPS - CAERS, AERS 9/04 TO 11/17
SUN PHARMA, UNIMED TECHNOLOGY, BASKA, INDIA - 483 11/01/2017 -
11/22/2017
CITRATED ZINC BISGLYCINATE - CAERS, AERS 9/04 TO 11/17
EPIPEN ADVERSE EVENTS
INDIVIDUAL RECS
INDIVIDUAL RECS
CELLTRION WARNING LETTER 01/01/2018 - 02/02/2018
FOIA LOG DEC 2017
LOG OF CLOSED REQUESTS FOR 483S 2017
PREVIOUSLY RELEASED 483, RESPONSE, EIR 12/31/2017 - 02/01/2018

K153660 K162309
LIST OF INSPECTIONS DEC 2017
CREGANNA MEDICAL, SYNERGY HEALTH, IRELAND - INSPECTION RECS
OLIVER-TOLAS HEALTHCARE PACKAGING, FEASTERVILLE, PA - EIR,
483, RECALL 05/23/2013 - 02/01/2018
EMICIZUMAB AERS
EDWARDS LIFESCIENCES - CARPENTIER EDWARDS PEIMOUNT MAGNA MITRAL
EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE MODEL
7300TFX MDRS
INVEGA LABELS
SUMITOMO CHEMICAL, JAPAN - 483 12/01/2017 - 12/31/2017
MOD-PAC CORPORATION, BUFFALO, NY - DEIR, 483, RECALL 02/15/2016
- 02/01/2018
WUXI APPTEC CO LTD, CHINA INTAS PHARMACEUTICALS LIMITED, INDIA
MALLADI DRUGS & PHARMACEUTICALS LTD, INDIA - 483 08/12/2013
- 09/08/2017
K882048
9176633 11742651 EXPAREL
ENFORCEMENT REPORT RECS 10/01/2011 - 02/01/2018
DRUG ESTABLISHMENT REGISTRATION SPREADSHEET 01/01/2018 -
01/31/2018
MEDOLAC LABORATORIES, LAKE OSWEGO, OR - INSPECTION REPORT
08/02/2017 - 08/31/2018
LOGS OF CONGRESSIONAL CORR
2017 NST 715 0614
CELLTRION INC - EIR, WARNING LETTER 01/01/2017 - 02/01/2018

TECFIDERA LABELS
MAQUET CARDIOPULMONARY AG GERMANY RECS RE OXYGENATOR
DISCONNECT ISSUE - REPORTS ETC 01/01/2012 - 02/01/2018
RECS RE FIELD SAFETY NOTICES, RECALL NOTICES MAQUET
CARDIOVASCULAR LLC ETC 01/01/2012 - 12/31/2014
ACTELION COMPLETE RESPONSE LETTER - RESPONSE 01/01/2010 -
12/31/2010
K150078 STUDIES
HARMLESS HARVEST THAILAND - CORR RE WARNING LETTER 11/13/2015 -
02/01/2018
DRUG ESTABLISHMENT REGISTRATION RECS
RYE FRESH, INC, CUPFUL PRODUCTS AS YOGURT, KEFIR 01/01/2014 -
02/01/2018
FLORIDA SUPPLEMENT CORP, HOLLYWOOD, FL - EIR 11/8-12/16/10
DMF SPREADSHEET
ANDA 208077
CTX LIFE SCIENCES PVT. LTD, INDIA - 483 01/01/2018 -
02/01/2018
FDA SOCIAL MEDIA MONITORING POLICY, PRIVACY IMPACT ASSESSMENT

NDA 008578
LIST OF INSPECTIONS JANUARY 2018
AUROBINDO UNIT IV, AURONEX - 482, FMD-145 11/02/2017 -
02/01/2018
LOG OF CLOSED REQUESTS FOR 483 JANUARY 2018
FOIA LOG JANUARY 2018
COMPLAINT RECS 01/23/2018 - 01/31/2018
APPLICATION FORMS
ODYSSEY FOODS, LLC, SEATTL, WA - 483 06/29/2017 - 07/11/2017

COLEMAN PEANUT COMPANY, SOUTH PRICE GEORGE, VA ETC - 483
05/13/2010 - 12/11/2017
OAK RIDGE PRODUCTS, LLC, MCHENRY, IL ETC - 483 05/05/2009 -
10/26/2017
JM SMUCKERS LLC, SCOTTSVILLE, KY ETC - 483 03/11/2010 -
05/16/2017
RECS RE DENIALS OF EXPANDED ACCESS IND 11/01/2011 - 02/01/2018

ROSEMARK BAKERY INC, ST PAUL, MN ETC - 483 05/02/2016 -
09/22/2017
SARANAC BRAND FOODS, INC, SARANAC, MI - 483 11/02/2015 -
11/28/2017
MOCON INC, MINNEAPOLIS, MN - EIR, 483, RECALL 06/20/2013 -
02/01/2018
NYC NEW YORK COLOR BIG BOLD VOLUME BY THE LASH, BLACK -
REGISTRATION, GMP CERTIFICATE
PRODUCTS AFRICANA, INC, PLAINFIELD, NJ ETC - 01/10/2017 -
08/22/2017
FOIA LOG 1/1/12-8/1/12
MILTENYI BIOTEC GMBH, GERMANY ETC - 483 05/18/2015 -
05/29/2015
ARCHER DANIELS MIDLAND COMPANY, FRANKFORT, IN ETC - 08/17/2015
- 12/04/2017
LIST OF INSPECTIONS
AMNEAL PHARMACEUTICALS OF NY, BROOKHAVEN, NY ETC - 483
11/15/2016 - 12/11/2017
ANDA 208532 EXCLUSIVITY RECS
HOSPIRA HEALTHCARE SRIPERUMBUDUR, INDIA - INSPECTION RECS
06/26/2016 - 02/01/2018
RECS RE RARE PEDIATRIC DISEASE DESIGNATION FOR SPARK
THERAPEUTICS LUXTURNA
K132987
IMPORT RECS
ZIMMER BIOMET INSPECTION RECS 07/07/2017 - 02/06/2018
K162594
PAYMENTS TO TRUMP HOTEL INTERNATIONAL 09/01/2016 - 02/07/2018

ANDA 090368
FDA AND ITG BRANDS - CORR, COMM, FILINGS ETC
2017-7898
SUBSYS AERS
DEXCOM, SAN DIEGO, CA, PHOENIX, AZ - EIR, 483, CORR 01/01/2017
- 02/02/2018
NDA 012791
AMERICAN PHARMACEUTICAL INGREDIENTS LLC, WATERFORD, MI
RECIPHARM PHARMASERVICES PRIVATE LIMITED, INDIA ETC 483
-12/01/2017 - 12/31/2017
PANACEA BIOTEC LIMITED, BADDI, INDIA RELIANCE LIFE SCIENCES
PVT LTD, INDIA - 483 12/01/2017 - 12/31/2017
K781693
CONTRACT BETWEEN STATE OF SOUTH CAROLINA AND FDA FOR TOBACCO
INSPECTIONS 01/01/2013 - 12/27/2017
6226292 6235927 6346333 AERS
GOTLANDSSNUS AB - SUBMISSIONS TO CTP, CORR ETC
ANDA 209207, 074937, 074916 SBA
CLINICAL TRIALS FOR DRUGS, BIOLOGICS WITHDRAWN, TERMINATED,
SUSPENDED ETC
LETTERS FROM FDA TO SPONSORS, MANUFACTURERS OF OTC LOPERAMIDE

CORR RE WARNING LETTER TO MEDTECH PRODUCTS RE MURINE EAR DROPS
FOR EARACHE RELIEF 09/19/2013 - 11/06/2014
ELLIQUENCE LLC, BALDWIN, NY - EIR 11/12/2013
483, EIR, RESPONSE RELEASED JAN 2018
EIR, 483, RESPONSE RELEASED DEC 2017
RECS RE DIDLAKE INC ETC, PERSONNEL RECS 09/21/2009 - 12/27/2017

CARESTREAM HEALTH INC INTERNATIONAL R&D FACILITY, CHINA -
01/15/2018 - 02/09/2018
BIORELIANCE, LTD, UK ETC - 483 03/14/2016 - 09/27/2017
ANDA 206394 TENTATIVE APPROVAL
FAERS GRASTEK 13927546
STERILMED, INC., PLYMOUTH, MN STRYKER CORP., TEMPE, AZ - EIR,
483 01/01/2010 - 02/05/2018
DRUG LISTING REQUIREMENTS RECS SECTION 510 OF FDCA RE
HYDROCORTISONE ACETATE SUPPOSITORIES BIO-PHARM INC
FAERS CASE 14330609,14257279,14141420, ETC
RECS RE SAMPLE 1030816.
483S RELEASED UNDER FOIA 01/01/2018 - 01/31/2018
DYNAVAX, GERMANY - EIR 01/01/2016 - 12/31/2016
K161470
DYNAVAX, GERMANY PRE-APPROVAL EIR 06/01/2017 - 06/30/2017
PFIZER, QUILLIVANT XR COMMUNICATIONS RE CURRENT MANUFACTURING
DELAY 10/01/2017 - 02/05/2018
LIST OF 483S 01/01/2018 - 01/31/2018
ATLANTA 483 12/01/2017 - 12/31/2017
BALTIMORE 483 12/01/2017 - 12/31/2017
CHICAGO DISTRICT 483 12/01/2017 - 12/31/2017
CIN DISTRICT 483 12/01/2017 - 12/31/2017
DALLAS DISTRICT 483 12/01/2017 - 12/31/2017
DENVER DISTRICT 483 12/01/2017 - 12/31/2017
DETROIT DISTRICT 483 12/01/2017 - 12/31/2017
DQ8432, product name Quattro II ADVERSE EVENTS
K070475, K091405, K103088 ETC
FLORIDA DISTRICT 483 12/01/2017 - 12/31/2017
KANSAS DISTRICT 483 12/01/2017 - 12/31/2017
LOS ANGELES DISTRICT 483 12/01/2017 - 12/31/2017
MINNEAPOLIS DISTRICT 483 12/01/2017 - 12/31/2017
NEW ORLEANS DISTRICT 483 12/01/2017 - 12/31/2017
NEW ENGLAND DISTRICT 483 12/01/2017 - 12/31/2017
NEW JERSEY DISTRICT OFFICE 12/01/2017 - 12/31/2017
NEW YORK DISTRICT 483 12/01/2017 - 12/31/2017
PHILADELPHIA DISTRICT 483 12/01/2017 - 12/31/2017
SEATTLE DISTRICT 483 12/01/2017 - 12/31/2017
ANDA 080198
CDER 483 12/01/2017 - 12/31/2017
HILL COUNTRY BAKERY, SAN ANTONIO, TX - 483 06/01/2014 -
06/30/2014
CDER 483 12/01/2017 - 12/31/2017
CDRH 483 12/01/2017 - 12/31/2017
PURDUE PHARMA SURVEILLANCE RESLTS, DRUG UTILIZATION PATTERNS
07/01/2012 - 02/05/2018
SAIED ASBAGH CV 02/05/2018
BNF 000145
REISDORF BROTHERS INC FARM STORE & FEED MILL, NORTH JAVA, NY -
CONTAMINATED HORSE FEED INVESTIGATION RECS, INSP RPTS,
EXHIBITS, ETC 2016
EIR RELEASED UNDER FOIA 01/01/2018 - 01/31/2018
RECS WITH ENTRY WU6-3030682-3/11/1/ for SEA CUCUMBER, OTHER
AQUATIC SPECIES
NDA 208944 ORPHAN PRODUCT RECS, DRUG APPROVAL RECS
CARDIOLOGS ECG ANALYSIS PLATFORM K170568
INSP CLASSIFICATION DATABASE, INSP CITATIONS DATABASE 1/94 TO
PRESENT
BUTTERFLY NETWORK K163510, CLARIUS K163138
FDA POLICY FOR MONITORING OF THE OFFICIAL FDA SOCIAL MEDIA
ACCOUNTS
FDA POLICY FOR FDA EMPLOYEES PERSONAL USE OF SOCIAL MEDIA
ACCOUNTS
KRATOM - WHITE PAPERS, ANALYSIS, LAB TESTS, ETC
KRATOM - EIGHT FACTOR ANALYSIS CONDUCTED IN RESPONSE TO A DEA
REQUEST
INVOKANA (CANAGLIFLOZIN) - AERS, INVESTIGATION RECS
MAQUET CARDIOVASCULARLLC, MAQUET MEDICAL SYSTEMS USA, MAQUET
CARCIOVASCULAR US SALES LLC - SAFETY NOTICES, RECALL NOTICES
MEMOS, INSPS, ETC
K964280
PROFICIENTRX, THOUSAND OAKS, CA - EIR 10/20-22/15
RECS RE ADVERSE EVENTS RE 44 REPORTED DEATHS OF KRATOM
01/01/2009 - 02/06/2018
FCN 1458
K091978
510K SUMMARY SIMPLEX HV CEMENT ETC 01/01/2000 - 02/07/2018

K172819
REMSIMA AERS
TOBACCO USER FEE RECS
K141281
NDA 18651/S011
CDER/OPQ/OTR Potency Analysis of Sumatriptan 100mg tablets, Dr
Reddys Laboratories Limited FY18-002-DPA-T ETC
ANDA 085966 LABELING
NDA 20-505/S-002
RECS BETWEEN FDA AND US SMOKELESS TOBACCO LLC
DEL MONTE FRESH PRODUCE, NA, PLANT CITY, FL ETC - 483
03/31/2014 - 12/08/2017
SLEEPMED INC, PEABODY, MA - EIR 09/01/2014 - 09/30/2015
DRUG LISTING HYDROCORTISONE ACETATE SUPPOSITORIES
FOIA LOG 10/06/2017 - 02/06/2018
THYNC GLOBAL INC USA 513(G) RESPONSE ETC 02/01/2013 -
02/15/2015
BACHEM AMERICAS, INC, TORRANCE, CA - EIR 10/25/2016 -
11/11/2016
ARKEMA INC FCN 406
K171669
HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTD, CHINA - 483, EIR,
RESPONSE 04/01/2016 - 12/31/2017
NDA 021348 COMPLETE RESPONSE LETTER
EMPLOYEES STATIONED IN INDIA 01/01/2009 - 02/07/2018
2018-663
FRESHBEV IIC, NEW HAVEN, CT - INSPECTIONS, FILINGS 01/01/2012 -
PRESENT
WELLSTAR DOUGLAS HOSPITAL MAMMOGRAPHY CENTER, WELLSTAR HOSPITAL
IMAGING CENTER, DOUGLASVILLE, GA - INSPECTION RECS 01/01/2010
- 02/01/2018
ANDA 208788 ANDA 210194
VK100, BONWRX, SILICON USED IN SPINE - COMMUNICATIONS,
ANALYSES, ETC 09/15/2006 - 12/31/2017
NDC 0409-6664-02
TRADE COMPLAINT RECS
COMMUNICATIONS BETWEEN FDA AND APPLICANTS RE SUPP NDA XARELTO
FOR NEW DOSING REGIMEN
NDA 008372
KRATOM AERS
AMA LABORATORIES, NEW CITY, NY - INSPECTION RECS 01/01/2015 -
02/01/2018
BIONDILLO'S BAKING COMPANY LLC, CHICAGO, IL - 483 01/09/2018 -
01/10/2018
LOPERAMIDE AERS
UNITED THERAPEUTICS CORPORATION, TRIANGLE PARK, NC - EIR
09/25/2013 - 09/27/2013
NIPOCURE LAWSUIT - EVIDENCE, EMAILS, DATA ETC 02/01/2007 -
11/01/2016
SCIENTIFIC RECORDS, EVIDENCE, EMAILS ETC RE DECISION TO BLOCK

NJOY AND OTHER E-CIGARETTE IMPORTERS 01/01/2007 - 04/30/2010
MEDWATCH 7153890
EPIPEN, EPIPEN JR CHEMISTRY OR LABELING SUPPLEMENTS, APPROVALS
2012-1795 2012-1888 2012-7014 2012-8257 2015-2958 2016-
2438 2016-6857
K072764
K170568
K760171, K770879, K772055, ETC
2018-214
K062339
NDA 021660
NDA 050467
K121447 K120196
NDA 020541
NDA 017970
RECS RELEASED UNDER FOIA RE TRP COMPANY, INC 01/01/2000 -
02/08/2018
BRAVECTO AERS
RECS RE APPROVAL OF TRILOSTANE
NICOPURE LAWSUIT - RECS
SINECATECHINS, CROFELEMER - DMF
DR PETER LENAHAN, NOVARTIS, EAST HANOVER, NJ - EIR
STUART LABORATORIES, MABEL, MN - RECS 2006 TO PRESENT
CLNCL TRIAL - DATA
FAP 2303
FAP 2304
ETHACRYNIC ACID, TELOR OPTHALMIC PHARMACEUTICALS INC - RECS,
CLNCL STUDIES
CORR BETWEEN FDA & REP DAVE BRAT 11/4/14 TO PRESENT
SKULL CLAMP - INTEGRA LIFE SCIENCES CORP MED SUN RPT
TRADING CORP, BROOKLYN, NY - EIR, 483, WARNING LTRS 2014 -
1017
CORR BETWEEN FDA & REP ANDY BARR 1/13 TO 2/6/18
FAP 2299
VAERS RPT 655398
DOXOFYLLINE - ROBERTS PHARMACEUTICALS EFFICACY
ARZYTA LLC, CHASKA, MN ETC 483 02/04/2009 - 10/06/2017
REGISTRATION DATA
TONIC WORLD CENTER SA DE CV COMMERCIAL BRANDS, MEXICO - IMPORT
ALERTS, WARNING LETTERS ETC 01/01/2008 - 02/06/2018
EXPAREL 9176633 10359058 10449119 ETC
FDA-2007-P-0053 FDA-2007-P-0054 RESPONSES TO PETITIONS
XCELIENCE LLC, TAMPA, FL - EIR, EXHIBITS 07/03/2017 -
07/17/2017
INTERTEK, PITTSFIELD, MA - EIR, 482, 483 ETC 05/28/2013 -
02/08/2018
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION, ANDOVER, MA ETC
- 483 08/18/2015 - 10/24/2017
KASHINATH G YADALAM, MD, LAKE CHARLES, LA ETC - 483 09/26/2011
- 11/09/2017
LISTING OF ACTIVE INGREDIENTS IN DRUGS 01/02/1962 - 02/10/2018

RECS RE CVM AND DECHRA LTD 11/02/2017 - 02/08/2018
NDA 020541
BAYER HEALTHCARE PHARMACEUTICAL MIRENA IUS MEDWATCH REPORT
06/01/2011 - 02/08/2018
LETITIA ROBINSON CALENDAR TRAVEL RECS
FDA EXPORT CERTIFICATES FOR DRUGS ETC WYETH PHARMACEUTICALS
LEXAPRO, ESCITALOPRAM AERS, INACTIVE INGREDIENTS
BIOLASE, IRVINE, CA - EIR 04/04/2017 - 04/06/2017
FLURALANER, AFOXOLANER, SAROLANER AERS
LIST OF API MANUFACTURER REGISTRATION DATES UQUIFA MEXICO ETC
01/01/1960 - PRESENT
Ninth Annual Report on Delays in Approvals of Applications
Related to Citizen Petitions and Petitions for Stay of Agency
Action for Fiscal Year 2016
NDA 012141
NDA 020726
NDA 020753
DEN140033
INSIGHT PHARMACEUTICALS, LLC WARNING LETTER CORR 09/13/2013 -
09/22/2014
CAP TOMATO LYCOPENE EXTRACT, TOMATO LYCOPENE CONCENTRATE
K172935
CORR BETWEEN HHS AND FDA RE DEEMING, COMMENTS TO DOCKET ETC
12/01/2011 - 12/27/2017
NATPARA 13663133 13663135 13695703 ETC
INDOCO REMEDIES, GOA, INDIA - 483 01/15/2018 - 01/19/2018
NATPARA 13187260 13500157 13500165 ETC
ARICEPT NONCLINICAL STUDY RECS
HEAVY METAL TESTING DATA 01/01/2013 - 12/31/2014
K082538 K111976 K162740
NDA 205552
FOIA REQUESTS 01/01/2017 - 02/09/2018
BLA 761042/S-001
KLOCKNER PENTAPLAST OF AMERICA, INC, GORDONVILLE, VA - EIR,
483, 482 09/01/2013 - 02/09/2018
K043555
HALYARD HEALTH, ALPHARETTA, GA - EIR MOST RECENT
POREX FILTRATION GROUP OF FAIRBURN, FAIRBURN, GA - EIR, 482,
483 09/03/2013 - 02/09/2018
AMANTADINE HYDROCHLORIDE ORPHAN PRODUCT DESIGNATION RECS
CERTIFICATES TO FOREIGN GOVERNMENTS FOR US FIRMS ETC 01/01/2000
- 02/09/2018
CADILA HEALTHCARE, MORAIYA, INDIA - 483 02/01/2018 - 02/09/2018

DAILY LOG 1/8-12/18
DAILY LOG 1/29/18-2/2/18
DAILY LOG 1/8-12/18
HHSF223200850014I, HHSF22301001T
DAILY LOG 1/2918-2/2/18
DAILY LOG 1/29/19-2/2/18
DAILY LOG 1/8-12/18
DAILY LOG 1/29/18-2/2/18
SAVIOR LIFETEC, TAIWAN - 483, FMD 145 11/01/2017 - 12/25/2017

DAILY LOG 1/8-12/18
DAILY LOG 1/29/18-2/2/18
DAILY LOG 1/29/18-2/2/18
DAILY LOG 1/29/18-2/2/18
SELENOMETHIONINE FOOD ADDITIVES 01/01/1998 - 12/28/2017
BRADSTREET WELLNESS CENTER, BUFORD, GA - 483 ETC 01/10/2010 -
02/10/2018
MOUSE SURROGATE ANTIBODIES MURINE EPIDERMAL GROWTH FACTOR
RECEPTOR 01/01/1992 - 01/01/2018
HEMLIBRA CASE REPORTS
ARROW RELIANCE INC, TUKWILA, WA - EIR 06/01/2016 - 12/31/2017

PREVALENCE OF CONDITIONS AS REPORTED BY DRUG MANUFACTURERS
REQUESTING ORPHAN DRUG DESIGNATIONS
ZITHROMAX FAERS 4136943, 3307405, 6648045, ETC
2017-9885
CLOSED FOIA REQUESTS 1/8-12/18
SAVIOR LIFETEC MIAOLI CITY - 483, FMD 145 11/01/2017 -
12/28/2017
CLOSED FOIA REQUESTS 1/29/18-2/2/18
LIFECORE BIOMEDICAL, CHASKA, MN - EIR 02/01/2017 - 08/31/2017

I am seeking to obtain any establishment inspection reports
(EIRs) for the Lifecore Biomedical facilities issued as a
result of the facility inspections that occurred 2/14/2017 -
3/2/2017
CLOSED FOIFA REQUETS 1-1-5/18
OOPD FDA, Designation Review -- Points to Consider (Jan 1993)

FDA FOIA LOG ABBOTT 12/01/2017 - 01/31/2018
CORR FROM INDIVIOR REQUESTING A MEETING WITH OCC OR CDER,
MEETING RECS 10/01/2017 - 12/20/2017
CELLTRION INC - EIR, 483 01/01/2017 - 12/29/2017
2016-10529
NDA 208910
K120961
14172620,14089092,13587819, ETC
NDA 205181
K113455
ANDA 207567
K974393
EMICIZUMAB RECS COMPASSIONATE USE, DR HOLBROOK HOLBROOK
01/01/2014 - 02/12/2018
CELLTRION, INC, INCHEON, KOREA - EIR 05/01/2017 - 01/01/2018

"Summary of Safety and Effectiveness, Therasonic Lithotripsy
Treatment System, Diasonics, Inc" 1998N-1134 Vol3 NFR1
Reference 5 TP890006
NDI 203
CELGENE CORPORATION, SUMMIT, NJ - EIR 03/01/2018 - 02/12/2018

NDA 022051
ULTA BEAUTY INC - CORR WITH FDA RE REPACKING AND SELLING USED
COSMETICS 10/01/2017 - 02/12/2018
FAREVA, FRANCE - EIR 05/01/2017 - 02/01/2018
INTRAOP MEDICAL CORPORATION, SUNNYVALE, CA - EIR 05/22/2017 -
05/25/2017
NDA 022341/S7, NDA 022341/S9, NDA 022341/S13 ETC
NDA 022044/S11 NDA 022044/S10, NDA 022044/S12, ETC
K113658, K071699, K150402, ETC
ACYCLOVIR CREAM APPROVAL DOCUMENTATION 01/01/2002 - 02/13/2018

Data on drug/biologics submissions and approvals
NDA 021077/S42
NDA 202343/S1, NDA 202343/S2, NDA 202343/S4
NDA 021695/S10
AIZANT DRUG RESEARCH SOLUTIONS, INDIA - 483, EIR 08/01/2017 -
08/31/2017
EYLEA AERS
FAREVA, FRANCE - EIR, 483, RESPONSE 02/01/2014 - 01/01/2015
NDA 022107/S2
AYANDA AND CO, GERMANY - 483, EIR 02/05/2015 - 02/15/2018
PROACTIV BLACKHEAD DISSOLVING GEL COMPLAINTS 01/01/2015 -
02/01/2018
PATHEON ITALIA SPA, ITALY - EIR 5/20/16
FDA issued Material Safety Data Sheet (MSDS) for the substance
known as Thimerosal
MARS PETCARE US INC, COLUMBUS, OH - 483 07/01/2017 -
09/14/2017
FCN 1767
ADVANTAGE MEDICAL ELECTRONICS, CORAL SPRINGS, FL - EIR
09/22/2014 - 09/24/2014
13404434 13246618 13800913 ETC
LISTING OF NDC NUMBERS AND ORPHAN DRUG DESIGNATION 02/13/2018
- 02/13/2018
K171556 K172268
DEXYCU NDA 208912 SBA
FSMA REINSPECTION INVOICE RECS 12/31/2016 - 02/13/2018
ZIMMER BIOMET - 483, EIR, WARNING LETTERS 01/01/2017 -
02/20/2018
K162323
CAPRICOR, CAP-1002 ADVISORY COMMITTEE MEETING MINUTES,
TRANSCRIPTS, IND FILINGS 12/07/2015 - 12/30/2017
CONSUMER COMPLAINT 152312
RFA-OD-17-003
FORM 3542 NDA 020845
RECS FROM ZIMMER BIOMET TO FDA DET-DO 02/01/2016 - 02/29/2016

EMAIL, CORR BETWEEN FDA AND ZIMMER BIOMETRE 483 08/01/2017 -
02/13/2018
SYNGENTA SEEDS, INC RECS BNF 151
IDE (G120003)
K832622 K843313
DMF 13343
TERBINAFINE AERS
DMF 13342
K172935
SALTWORKS, INC, WOODINVILLE, WA - INSPECTION RECS 05/01/2011 -
02/13/2018
HUMIRA AERS
GOCOVRI ORPHAN DRUG APPLICATION RECS
PURE SOURCE, INC, MIAMI, FL - EIR, EXHIBITS ETC 08/11/2011 -
02/24/2014
NDA 208845
SUN PHARMA, HALOL, INDIA - 483 02/01/2018 - 02/15/2018
K140866
BOEHRINGER INGELHEIM PHARMA, GERMANY - 483 10/02/2017 -
10/06/2017
K121229
SUN PHARMA HALOL, INDIA - 483 02/09/2018 - 02/26/2018
CRL, RENO, NV - INSPECTION RECS
NATCO, MEKAGUDA - 483 02/10/2018 - 02/25/2018
VACCINATIONS INSERTS
AAREN LABORATORIES, LLC, CALIFORNIA, CA AAREN SCIENTIFIC INC,
CA ABBOTT MANUFACTURING, MALAYSIA ETC - EIR, EXHIBITS :
01/01/2010 - 02/14/2018
CVM APPROVED ANALYTICAL TEST METHODS RE NICARBAZIL IN TYPE C
POULTRY FEEDS 02/02/2001 - 02/14/2018
EXPAREL AERS
NDA208751 SBA
LIST OF 483S 01/01/2018 - 01/31/2018
12/01/2017 - 12/31/2017 483s issued by the San Francisco DO

FRESENIUS KABI COMPOUNDING, CANTON, MA - 483 02/14/2018 -
02/14/2018
K150880
PITOCIN SUMMARY AND COMPLETE REVIEW PACKAGE 01/01/1960 -
02/01/201
WONDERFUL PISTACHIOS & ALMONDS LLC, LOST HILLS, CA - EIR
ATTACHMENTS, LAB RESULTS 01/01/2016 - 02/01/2017
K955445 K953504 K090106 ETC
K172623 K172268
BEND RESEARCH INC, BEND, OR - 483 06/26/2017 - 06/30/2017
483S OXYGEN, MEDICAL GAS 01/01/2017 - 12/31/2017
TRP COMPANY, INC, RENO, NV - CORR, INSPECTION RECS, ETC
01/01/2000 - 02/15/2018
AUROBINDO PHARMA, UNIT 4 SUN PHARMA, HALOL NATCO PHARMA,
MEKAGUDA - 483 01/15/2018 - 02/16/2018
EXONDYS 51 - REVIEW OF SUPPLEMENT
KITE PHARMA, EL SEGUNDO, CA - INSPECTION RECS
RADI ANALYZE AND PRESSURE WIRE SENSOR RADI MEDICAL SYSTEMS, ST
JUDE MEDICAL 510K
NOVARTIS CELL & GENE THERAPY, MORRIS PLAINS, NJ - INSPECTION
RECS
K131452
IND 16278
AMRI RENSSELAER, INC, RENSSELAER, NY - EIR 05/01/2015 -
05/22/2015
IND 16130
CPT1200729
BEMIS HEALTHCARE PACKAGING, OSHKOSH, WI - EIR, 483, ETC
02/01/2014 - 02/15/2018
K131966
ANDA 086069 SBA
DEN160058
GRN 716
NADA 030-535
K180107
KUBALA EXTERNAL DRAINAGE CATHETER 510K
PRILOSEC - ISR 3673018, 3843816, 3997717, ETC
REVIEW RECS RE APPROVAL OF HP ACTHAR
MedWatch Reports (adverse events) involving Octagam 5% (immune
globulin intravenous) Human for lot #K737E8441 12/01/2017 -
01/03/2018
INVOKANA (CANAGLIFLOZIN) - AERS
JANSEN PHARMACEUTICALS, INC -INVOKANA (CANAGLIFLOZIN,METFORMIN

HCL) AERS, CORR, 15 DAY ALERTS, ETC
FAKE FDA SOCIAL MEDIA PAGES OR ACCOUNTS - RECS
PHARMEDIUM SERVICES, LLC, TN, NJ, MI, TX - 483 11/27/17-1/5/18

OREGON POTATO CO, CRF FROZEN FOODS, FREEZE PACK, PASCO, WA -
LISTERIA MONOCYTOGENES OUTBREAK RPTS 3/16
INDIVIDUAL RECS
INVOKANA (CANGLIFLOZIN), INVOKAMET (CANAGLIFLOZIN, METFORMIN
HCL, INVOKAMET XR, ETC - SUPPL NDA 6/22/16, 12/22/16, MEETINGS
NDA 6/22/16, ETC
ORPHAN DRUG DESIGNATION AND EXCLUSIVITY FOR DUOPA (CARBIDOPA,
LEVODOPA @99-1294) RECS
PROPOSED PREVALENCE CALCULATION FOR DUPOPA'S ORPHAN DESIGNATION
USE THAT POST-DATES THE GRANT OF ORPHAN-DRUG DESIGNATION
1/18/00
BIORAMO, LLC - LISINOPRIL ORAL SOL CARMEL BIOSCIENCES -
VALSARTAN ORAL SOL PHARMEDIC CO - PAPAVERINE TOPICAL GEL -
MEMOS, CORR, MINS, ETC
INDIVIDUAL RECS
DORPHAN-DRUG DESIGNATION AND ORPAN-DRUG EXDCLUSIVITY FOR DUOP A
(CARBIDOPA, LEVODOPA) #99-1294 - THIRD-PARTY COMM, MINS OF
TELCONFERENCES OR MEETINGS
CHEF CUPBOARD'S CHICKEN STOCK - TAPEWORM STATEMENTS,
INTERVIEWS, TELEPHON CORR, ETC (CERTIFIED(
CHIPOTLE MEXICAN GRILL, MALIBU, CA - E COLI FOOD POISONING
OUTBREAK- CMPLNTS, RPTS, INVESTIGATIONS, ETC 2015, 2016
STEM CELLS - PROCEDURES THAT GO INTO EXTRACTING, BANKING AND
DEPLOYING ADIPOSE STEM CELLS - PROTOCOLS USED BY LABS DURING
THE BANKING AND PROCESSING STAGES
CMPLNT 38879 4/3/17 TO 2/8//18
LIST OF FOIA REQUESTS - LAST 3 MONTHS
CHEMENCE MEDICAL RPODUCTS INC, ALPHARETTA, GA - EIR 11/13/15

PETITION FOR HYDROXPROPYL DISTARCH PHOSPHATE - SAFETY AND
TOXICOLOGY STUDIES, GRAS DETERMINATIONS
PETITION FOR SODIUM TRIMETAPHOSPHATE - SAFETY AND TOXICOLOGY
STUDIES, GRAS DETERMINATIONS
RED YEAST RICE, RED FERMENTED RICE, LOVASTATIN, ETC - EMAILS,
ATTACHEMSTS SENT AND REC'D BY FDA TO DR. PIETER COHEN 1/1/16
AND 2/1/18
DKT 80N-0447 VOL 2 REF 1,3 & 4
INDIVIDUAL RECS
K173119
ANDA 208077 SBA
ANDA 090753 ANDA 090872 ANDA 090930 TENTATIVE APPROVAL LETTERS

CORR BETWEEN FDA AND MILLENNIUM PRODUCTS, INC RE GT ORGANIC
KOMBUCHA, ETC 02/01/2009 - 02/16/2018
K971303 K920792 K803250
K942321
NDA 017697 S27, 31 SBA
OCULAR THERAPEUTIX - EIR, 483 ETC 01/01/2014 - 08/01/2017
AMAZON.COM KYDC, LEXINGTON, KY AMAZON FULFILLMENT SVCS INC,
BREINGSVILLE, PA MIDDLETON, DE ETC - INSPECTION RECS
10/19/2012 - 10/04/2017
FOIA REQUESTS PERFECT DAY, BEYOND MEAT, IMPOSSIBLE MEAT ETC
07/31/2017 - 02/16/2018
TESTING RESULTS
GLATIRAMER ACETATE AERS
PPD, RICHMOND, VA - INSPECTION RECS
NATCO PHARMA LTD, INDIA - 483 02/12/2018 - 02/19/2018
K163475
TOCILIZUMAB ORPHAN DESIGNATION RECS 07/31/2012 - 04/29/2013
DKT 98P-0034
NORTHWESTERN CENTER FOR CLINICAL RESEARCH, CHICAGO, IL - CORR
02/01/2007 - 12/30/2008
FCN 1746
OCALIVA AERS
BAXTER HEALTHCARE CORP, MARION, NC - 483 11/06/2017 -
11/17/2017
INTERNATIONAL MEDSURG CONNECTION, INC, SCHAUMBURG, IL - 483
10/25/2017 - 11/22/2017
KALCHEM INTERNATIONAL, INC, LINDSAY, OK - 483 10/12/2017 -
11/03/2017
HOSPIRA, MCPHERSON, KS - 483 10/16/2017 - 10/27/2017
K942321
HEALTH SCIENCE PRODUCTS INC, HUEYTOWN, AL 483 10/11/2017 -
10/30/2017
MILBAR LABORATORIES, INC, EAST HAVEN, CT- 483 12/07/2017 -
12/27/2017
MCKESSON PACKAGING SERVICES, CONCORD, NC - 483 12/12/2017 -
12/15/2017
METHOTREXATET ORAL SOLUTION ORPHAN DESIGNATION RECS 08/27/2015
- 04/25/2017
SAMSUNG BIOLOGICS CO LTD, KOREA - CORR, COMPLAINTS ETC
THE WILLIAMSBURG WINERY LTD, WILLIAMSBURG, VA BECTON DICKINSON
& CO, SPARKS, MD MYLAN PHARMACEUTICALS INC, MORGANTOWN, WV -
483 02/07/2014 - 08/25/2017
VACCINE LABELING
INDIVIDUAL RECS
CUSTOM SYNTHETICS DEVELOPMENT, INC, ST JOSEPH, MO - 483
10/16/2017 - 11/06/2017
ENTEROMEDICS, INC, ST PAUL, MN - 483 11/28/2017 - 12/18/2017

CAMBRIDGE ISOTOPE LABORATORIES, TWEKSBURY, MA - 483 10/16/2017
- 11/07/2017
ELBA INC, TROY, MI - 483 09/11/2017 - 10/05/2017
GENESIS BPS, LLC, RAMSEY, NJ - 483 11/01/2017 - 11/20/2017
CIL ISOTOPE SEPARATIONS, LLC, XENIA, OH - 483 11/13/2017 -
12/13/2017
BECKMAN COULTER, INC, MIAMI, FL - 483 07/25/2017 - 10/16/2017

EX0000026
DUKE CLINICAL RESEARCH INSTITUTE, DURHAM, NC PATHEON
MANUFACTURING SERVICES, LLC, GREENVILLE, NC ETC 483 10/26/2015
- 05/19/2017
DEAR HEALTH CARE PROVIDER LETTERS RE PRESCRIPTION DRUG, DRUG
CLASS 01/01/2010 - 12/31/2016
BIOCON MALAYSIA - 483 02/01/2018 - 02/15/2018
DOMPERIDONE AERS
21ST CENTURY CURES NEW DRUG APPROVALS STATEMENTS 12/13/2016 -
02/17/2018
BIOCON, MALAYSIA 483 JAN 2018
K171956 K160229
BIOCON, MALAYSIA - 483 02/01/2018 - 02/18/2018
K973500, K942044, K992833, ETC
NDA 021862
BAYER PHARMA AG, KAISER-WILLHELM-ALLEE - 483 01/01/2017 -
01/31/2017
INSYS THERAPEUTICS, ROUND ROCK, TX - 483 01/01/2017 -
01/02/2018
PREGNER FOODS ASSOCIATED WHOLESALE GROCERS - CMPLNTS
SE0013978, SE0013979, SE0013980, ETC - REV SUMMARY
SE0000490, SE0000491, SE0000493, ETC - REV SUMMARY
CLEAN MEAT, SYNTHETIC MEAT, THE GOOD FOOD INSTITUTE, MEMPHIS
MEATS - CORR
P RICHTER INFLUENCE OF CIGARETTE COMPONENTS, 3/14 EMAIL, JH
LAUTERBACH2013, ETC
FA-2016-N-114A-0001, FDA-2016-D-1307-0001, FDA-2016-D-2285-0001

FDA-1996-P-0400- DRAFT-0001, 0003, 0004, ETC
FDA-2014-S-0023, FDA, 2015-S-0023, FDA 2016-S-0023,ETC-
FUNCTION NOTIFICATION LTRS
78N-1945, 78N-2014
FDA-1975-S-2036
CELGENE CORPORATION, SUMMIT, NJ CELGENE, BERKELEY HEIGHTS, NJ

GENEWIZ LLC, S PLAINFIELD, NJ - 483 03/31/2015 - 01/25/2017
FDA-2001-C-0209, FDA-2002-F-0198, FDA-2004-F-0321, ECT
FDA-1993-G-0220
FDA-1993-G-0220-0009
86P-0758
FDA-2015-P-1201, FDA-2016-P-1674, FDA-2016-P-2377, ETC
NDI NOTIFICATION RECS
VOL 210642
86A-0366
96P-0376
GENERAL & PLASTIC SURGERY PANEL
HYDRO PEROXIDE 35% FOOD GRADE
FDA -1980-N-0148
ELVEN JOE SWISHER CERTIFICATION AS AN ASSAYER WITH THE FDA -
RECS
CATEGORIZATION PROCESS FOR PURIFIED WATER AND INSOLUBLE
PHYTOCOMPOUNDS
ACETAMINOPHEN PREPARATIONS - ISRS 11397188, 11824366, 11841794,
ETC
INDIVIDUAL RECS - VAERS
GUTHY-RENKER - WEN CLEANSING CONDITIONER PRODUCTS INVESTIGATION

LEVOPHED, ARMAINE, INTROPIN - MEDICAL REVIEW RECS
2017-8695
ANDA 204841
INDIVIDUAL RECS
RECS RE RECALL KIRKLAND, KIRKLAND SIGNATURE BRAND 01/01/2007 -
01/01/2018
K002892
LIAM FOX, BRITAIN SECRETARY OF STATE FOR INTERNATIONAL TRADE -
CHLORINATED CHICKENS AND THE IMPACT ON TRADE RELATIONS BTWN US
AND BRITAIN CORR 6/17 TO 11/17
INSPECTIONS DATABASE RECS
MOU RECS
K172791
K101241
K101098
MIMEDX TISSUE SERVICES - FDA3356, FDA3500A, ETC 01/01/2010 -
02/19/2018
ADEQUAN IM NADA 140-901 APPROVAL LETTER
AERS 7108727, 7826911, 6272606, ETC

SPREADSHEET DRUG MASTER FILE 01/01/1996 - 12/31/1996
K150883
K163485
NDA 020459
K021737
THE MERIDIAN BIOSCIENCE, INC, CINCINNATI, OH - EIR UNREDACTED
11/01/2017 - 12/31/2017
HERSHEY COMPANY OF PENNSYLVANIA, BRITISH GOVERNMENT OFFICIALS

WORKING WITH TRADE OR FOOD STANDARDS, LET'S BUY BRITISH IMPORTS
OF NEW JERSEY, ETC - IMPORTING OF BRITISH CHOCOLATE CORR 1/14
TO 2/16
AERS REPORTING DOMESTIC VIOLENCE BY DRUG
IV PUSH CEFEPIME - AERS
JM SMUCKER CO - PENTOBARBITAL CONTAMINATION OF PET PRODUCTS
RECS
AMITRYPTYLINE, EFFEXOR, MIRTAZIPINE - RECS
ENFORCEMENT REPORT RECALL RECS 10/01/2011 - 01/02/2018
NUPLAZID - AERS 2/19/17
HYDROXYPROPYL DISTARCH PHOSPHATE - GRAS DETERMINATIONS,
CHEMISTRY AND TOXICOLOGY MEMOS
SODIUM TRIMETAPHOSPHATE PHOSPHATE - GRAS DETERMINATIONS,
CHEMISTRY AND TOXICOLOGY MEMOS
BAYER PHARMA AG, GERMANY - 483 01/12/2017 - 11/14/2017
FOIA LOG 01/01/2017 - PRESENT
LIST OF 74 MFRS OF IR OPIOID ANALGESICS
CALYXT, FDA'S OFFICE OF THE COMMISSIONER, CFSAN, CVM, OFFICE OF
GLOBAL REGULATORY OPERATIONS AND POLICY - EMAILS 1/11 TO THE
TIME THAT EMAILS ARE COLLECTED
2017-4900
IKHLAS A KAHN, UNIV OF MISSISSIPPI NATIONAL CENTER FOR NATURAL
PRODUCTS RESEARCH - CORR 1/1/10 TO 8/7/17
FINAL OPINIONS, ADMINSTRATIVE STAFF MANUALS, RULES OF
PROCEDURES, ETC
SPREADSHEET OF INSPECTION CLASSIFICATIONS 10/01/2011 -
12/31/2017
INFO WARE LIFE SUPPLEMENTS, CAVEMAN, LIVING DEFENSE, ANTHROPLEX
- CMPLNTS
BOTANICAL EDUCATION ALLIANCE (BEA, BOTANICAL LEGAL DEFENSE) -
RECS SUBMITTED TO FDA 1/16 TO 11/16
SUPPLY SIDE WEST, LAS VEGAS, NV - ARRESTS 2017
ARTEGRAFT, NORTH BRUNSWICK, NJ - EIR 01/13/2015 - 01/28/2015

RECS RE CARCINOGENS IN FOODS 01/01/2016 - 02/20/2018
RECS RE CLINICAL HOLD TISSUEGENE-C 01/01/2006 - 02/20/2018
NATIONAL BIOLOGICAL CORPORATION, BEACHWOOD, OH - EIR 03/06/2017
- 03/20/2017
FAP 9B4653
TAINIO TECHNOLOGY AND TECHNIQUE INC, TAINIO BIOLOGICALS,
SPOKANE WA, CHENEY, WA COMPLAINTS 01/01/2007 - 02/20/2018
INFINITY RESOURCES, INC, COHERENT RESOURCES, INC, SPOKANE, WA,
CHENEY, WA - COMPLAINTS 01/01/2007 - 02/20/2018
ANNUAL DRUG ESTABLISHMENT REGISTRATION STATUS INFORMATION
SPREADSHEET 01/01/2017 - 12/31/2017
LL'S MAGNETIC CLAY, INC DBA ENVIROMEDICA, AUSTIN, TX -
COMPLAINTS 01/01/2017 - 02/20/2018
MATERIALS, POLICIES, AND MEMOS THAT OUTLINE HIRING PROTOCOLS OF
FOREIGN SCIENTISTS
NOVARTIS CONSUMER HEALTH, INC, LINCOLN, NE - EIR 05/01/2017 -
12/31/2017
RECS PROVIDED TO SEN CLAIRE MCCASKILL IN RESPONSE TO HER
REQUEST DATED 4/7/16
K970321
MATERIALS RELATED TO DEREGULATION TASK FORCE ORGANIZATION,
CONSIDERATIONS, RECOMMENSATIONS AND DETERMINATIONS RELATED TO
DIVISIONS WITHIN EVERY AGENCY
ARUP LABORATORIES, SALT LAKE CITY, UT - 483 01/02/2017 -
02/01/2018
ACCESS CITED MATERIAL
HHSF22301043T TASK ORDER
EARTH ANIMAL VENTURES LLC, SOUTHPORT, CT- EIR 02/16/2018 -
02/23/2018
COMPLAINT 150262
VBI VACCINES INC - CORR WITH FDA 07/01/2015 - 02/28/2018
FDA'S POSITION ON SYNTHETIC BOTANICALS CONSTITUTING NEW DIETARY
INGREDIENTS
CHARLIE SEIFE - FOIA REQUESTS
OXIRACETAM - IND, COMPOUNDING PHARMACY REQUESTS, IMPORT ALERTS,
ETC
PHENOTROPIL, CARPHEDON - WHITE PAPERS, IMPORT ALERTS, TESTING,
ETC 1/1/12 TO 8/15/17
VENABLE LLP - RECS SUBMITTED TO THE FDA 9/16 TO 11/16
DI-CAFFEINE MALATE - NEW DIETARY INGREDIENT NOTIFICATIONS, GRAS
NOTIFICATIONS
FDA DIGITAL HEALTH SOFTWARE PRE-CERTIFICATION PILOT PROGRAM
CORR BETWEEN FDA AND REP ROD BLUM 02/01/2015 - 02/21/2018
ALPINE BIOMED APS, DENMARK - EIR 08/07/2017 - 08/09/2017
ANDA 207550
DEN160018
FAP 2B4338
PRECISION SPINE, INC, PEARL, MS - EIR 03/16/2015 - 04/16/2015
LIST OF TEMPORARY MARKETING PERMITS ISSUED THAT ALLOWS THE USE

OF THE DRAINED WEIGHT AS THE MEASUREMENT OF THE FILL OF
CONTAINER INSTEAD OF PRESSED WEIGHTS TO COMPLY WITH CANNED TUNA
STANDARD OF IDENTITY
Foreign Letters of Approval for Export of Medical Device

HIGHLAND PHARMACY, ALBUQUERQUE, NM - 483 01/03/2007 -
02/21/2018
K162701
POLARITYTE CORR WITH FDA RE REGISTRATION OF SKINTE AS HCT/P
10/21/2016 - 02/05/2018
K041007
MENAUL COMPOUNDING PHARMACY, ALBUQUERQUE, MN - 483 01/03/2007 -
02/21/2018
K131895
GRN No. 687
ZOETIS, INC, LINCOLN, NE FRESENIUS MEDICAL CARE RENAL

THERAPIES GROUP, LLC, WALTHAM, MA ETC 483 01/01/2018 - PRESENT
No Objection Letters (NOLs) for Recycled Plastics #119 and #203

FCN 1272
OLIVE TREE COMPOUNDING PHARMACY, ALBUQUERQUE, NM - 483
01/01/2017 - 02/21/2018
K173450
2011-591, 2012-5077, 2012-6315, ETC
EMERITA (TRANSITIONS FOR HEALTH), PORTLAND, OR - EIRS, 483S,
WARNING LTRS, ETC LAST 10 YRS
CELLTEX, HOUSTON, TX STEMGENEX, LA JOLLA, CA MAYO CLINIC,
ROCHESTER, MN, ETC - LAB PROCEDURES
NURSE ASSIST INC - SALINE FLUSH IV SYRINGE RECALL,
INVESTIGATION RECS
MOUNT FRANKLIN NUTRITIONALS, SUMTER, SC - EIR 01/21/2015 -
01/02/2018
KLS MARTIN LP - ZURICH DISTRACTION SYS K010139
MICHELSON VIVOSIGHT TOPICAL OCT SYS K093520 AGFA SKINTELL
K132800
MAGSEED MAGNETIC MARKER SYS K173587
NXSTAGE MEDICAL - PERITONEAL DIALYSIS PRODUCTS CORR, APRVL RECS

LATIN PRODUCTS IMPORTS LLC - ENTRY NUMBER AMN00350278
LATIN PRODUCTS IMPORTS LLC - ENTRY NUMBER AMN00343166
MTG BTWN ALEX AZAR AND OFFICE OF THE COMMISSIONER, CHIEF
COUNSEL, EXECUTIVE SECRETARIAT'S DIVISION OF EXECUTIVE
OPERATIONS, REGULATORY SCIENCE AND INNOVATION
RECS RE ACRYLAMIDE 01/01/2002 - 02/12/2018
DEN170022
MEDTRONIC NEUROMODULATION, MINNEAPOLIS, MN - EIR 05/01/2017 -
02/22/2018
ANDA 209426
K62701
FCN 763 and/or FAMF 788
BK090048, BK110061, BK120057, BK120066
QUALITY INGREDIENTS, BURNSVILLE, MN - 483, RESPONSE 05/01/2015
- 05/31/2015
K160615
K040011 K060065 K950388
INTERNATIONAL MEDSURG CONNECTION, SCHAUMBERG, IL - EIR
10/23/2017 - 11/30/2017
FOIA LOG FEB 2018
LOG OF CLOSED REQUESTS FOR 483S FEB 2018
2018-560 2017-10636 2018-222
K133968
NDA 019430 ETC
2017-9937 2017-10156 2017-10657 2017-10737
2017-10375 2017-10637 2018-148 2018-483
2018-219 2017-10632 2017-10635 2017-10662
BIOCON, MALAYSIA - 483 02/01/2018 - 02/19/2018
BIOCON, MALAYSIA - 483 02/01/2018 - 02/19/2018
BIOCON, MALAYSIA - 483 02/01/2018 - 02/19/2018
BIOCON, MALAYSIA - 483 02/01/2018 - 02/19/2018
BIOCON, MALAYSIA - 483 02/01/2018 - 02/19/2018
BIOCON, MALAYSIA - 483 02/01/2018 - 02/19/2018
BIOCON, MALAYSIA - 483 01/01/2018 - 02/21/2018
NDA 020262
SUN PHARMACEUTICALS INDUSTRIES, HALOL, INDIA - 483 OR EIR
02/12/2018 - 02/22/2018
DIVI'S LABS UNIT 1, INDIA - 483 02/01/2018 - 02/19/2018
REVIEW OF PUBLISHED STUDY REPORTS 01/01/2014 - 02/20/2018
INTERNAL ANALYSIS, REVIEWS, MEMOS, RERPORTS ETC DEPI, DBRUP
01/01/2014 - 02/20/2018
RW PACKAGING LTD, WINNIPEG, CANADA - 483 06/24/2016 -
02/20/2018
AUROBINDO PHARMA UNIT, INDIA - 483 02/16/2018 - 02/21/2018
AUROBINDO UNIT 4, HYDERABAD, INDIA - 483 02/01/2018 -
02/20/2018
AUROBINDO PHARMA, UNIT 4, I NDIA - 483 02/09/2018 - 02/21/2018

LEVOFLOXACIN LABELS, SAFETY DATA SHEETS, BLACK BOX WARNINGS ETC
01/01/2013 - 01/01/2017
AUROBINDO PHARMA UNIT 4 HYDERABAD INDIA - 483 02/12/2018 -
02/20/2018
AUROBINDO PHARMA UNIT 4 HYDERABAD INDIA - 483 02/12/2018 -
02/20/2018
EYLEA CASE REPORTS
NDA CMC INDA DRUGS CONTAINING CANNABIDIOL
MEDWATCH REPORT
OSE REVIEW OF STUDY 01/01/2014 - 02/20/2018
2003-577
2003-6667
2003-7069
2003-7221
2003-10151
NUPLAZID, INGREZZA, OCALIVA ETC AERS
2003-7340
2003-10828
2003-3743
2003-3755
2003-3824
2003-7997
2003-8486
2003-8847
2003-8958
2003-9912
NADA 098-379 FOIA SUMMARY
2003-10105
2003-10115
2003-10148
2003-10821
2003-10986
2003-11047
2003-11109
2003-11698
2003-13449
2003-13805
XERMELO AERS
2003-14320
2003-14519
2003-15180
2003-15192
2003-15521
NATEGLINIDE - AER
NUPLAZID - AER
NUEDEXTA - AER
POVERTY GUIDELINES FOR 2018
CANAGLIFLOZIN(INVOKANA) NDA 20-4042 DAPAGLIFLOZIN (FARXIGA)

NDA 20-2293 EMPAGLIFLOZIN (JARDIANCE) NDA 20-4629 - CMPLNTS
INDIVIDUAL RECS
NIVOLUMAB (OPDIVO) - FAERS
DURAGESIC - FENTANYL TRANSDERMAL PATCH - APRVL, WARNING
FENTANYL PATCH PUBLIC ADVISORY 7/15/05 12/21/07 6/22/13
LIBRAX NDA 12-750 - CHANGE IN REGULATORY STATUS
Zilretta NDA Approval Package
CRO TO PERFORM PHASE 1 CLINICAL TRIAL OF HS-10296 01/27/2016 -
02/08/2018
VARUBI AERS
AUROBINDO PHARMA LTD, INDIA - 483 02/12/2018 - 02/20/2018

RABAVERT AERS
NDA 206911
ANTIBIOTICS APPLICATION FORMS 1962 TO 1997
AUROBINDO PHARMA LTD, INDIA - 483 02/12/2018 - 02/20/2018
VIKSHARA TRADING & INVESTMENTS LTD, INDIA - 483 10/18/16
TEVA PHARMACEUTICAL AND CHEMICAL LTD, CHINA - 483 09/26/2016 -
09/29/2016
KEYTRUDA SUMMARY REVIEW, MEDICAL REVIEW, ETC 01/01/2017 -
02/21/2018
SAL PHARMA, INDIA - 483 06/27/2016 - 07/01/2016
SANDOZ ADVAIR COMPLETE RESPONSE LETTER
DEXTENZA COMPLETE RESPONSE LETTER, CORR, ETC 07/25/2016 -
07/11/2017
NDA 022051 S 17 LABELING
NDA 018333
NEVRO CORPORATION, REDWOOD CITY, CA, DIPLOMAT SPECIALTY
PHARMACY, TEMECULA, CA SYNERGY HEALTH IRELAND - 483,
INSPECTION NOTES 08/01/2017 - 01/02/2018
CASPOFUNGIN, CASPOFUNGIN ACETATE, MICAFUNGIN, ETC AERS
AUROBINDO PHARMA UNIT 4, INDIA - 483 02/12/2018 - 02/20/2018

AUROBINDO UNIT 4 INDIA - 483 02/01/2018 - 02/21/2018
HEMLIBRA CASE 13294078, 13479547, 13479556, ETC
AUROBINDO, UNIT 4 INDIA - 483 02/10/2018 - 02/21/2018
FOIA REQUESTS
ADVERSE EVENT DATA
BIOCON, MALAYSIA - 483 02/01/2018 - 02/22/2018
ANDA 080198
BIOCON, MALAYSIA AUROBINDO UNIT 4, I NDIA SUN PHARMA, HALOL,
INDIA - 483 02/01/2018 - 02/21/2018
BIOCON, MALAYSIA - 483 02/01/2018 - 02/22/2018
ORANGE BOOK RECS 02/07/1980 - 02/21/2008
HHSF223201710132C
BIOCON, MALAYSIA - 483 02/01/2018 - 02/19/2018
COMPLAINT RECS
K172066
K161391
K130665
RECALL # F-1735-2017 F-1736-2017, F-1737-2017, ETC
K153642
BIOCON, MALAYSIA - 483 12/01/2017 - 02/22/2018
NDA 202158
WUXI BIOLOGICS, WUXI CITY, CHINA - 483 08/02/2017 - 02/22/2018

MEDICAL DEVICE GENERAL ELECTRIC D670 NM CZT/CT IMAGING CAMERA
APPROVAL RECS
FAERS 11003239 8564288 8525532 ETC
BIOCON, MYLAN MALAYSIA - 483 12/01/2017 - 02/22/2018
CITRON SUBMISSION ACTHAR GEL 01/01/2013 - 02/01/2018
YUKI GOESEI KOGYO CO, LTD, JAPAN DAITO PHARMACEUTICAL CO LTD,
JAPAN CHUGAI PHARMA MANUFACTURING CO LTD, JAPAN - 483
11/01/2017 - 11/30/2017
BIOCHEM LABOR FUN BIOLOGISCH UND CHEMISCHE ANALYTIK GMBH,
GERMANY ONCOTEC PHARMA PRODUKTION GMBH, GERMANY - 483
11/01/2017 - 11/30/2017
K163579
SUN PHARMACEUTICALS LTD, HALOL, INDIA - 483 02/01/2018 -
02/23/2018
NDA 20222
02/23/2018
02/23/2018
BIOCON, MALAYSIA - 483 07/01/2017 - 02/23/2018
SANDOZ GMBH, AUSTRIA - 483, EIR 01/21/2016 - 01/29/2016
02/23/2018
02/23/2018
AUROBINDO UNIT 4, INDIA SUN PHARMACEUTICALS LTD, HALOL, INDIA
- 483 02/01/2018 - 02/23/2018
ENTRIES FOR DEVICE PROBLEMS ASSOCIATED WITH THE DORSAL ROOT
GANGLION STIMULATOR 01/01/2015 - 01/03/2018
02/23/2018
02/23/2018
02/23/2018
02/23/2018
02/23/2018
02/23/2018
PRILOSEC AERS
BIOCON, MALAYSIA - 483 02/01/2018 - 02/23/2018
"Electronic Submission of Allegations of Regulatory Misconduct

Associated with Medical Devices" 01/01/2014 - 02/20/2018
GIVE AND GO PREPARED FOODS CORP COMMUNICATIONS RECALL VOLUNTARY
01/01/2017 - 09/30/2017
Requests for Inspection by an Accredited Person under the
Inspection by Accredited Persons Program 01/01/2013 -
02/20/2018
AUROBINDO UNIT 4 INDIA - 483 02/15/2018 - 02/23/2018
PRODUCTS AFRICANA INC, PLAINFIELD, NJ ETC 483 11/04/2013 -
08/22/2017
GSK VACCINES SRL, ITALY ETC ate Range: 12/23/2013 - 10/19/2017

LSG SKY CHEFTS NORTH AMERICA, MIAMI, FL ETC - 483 01/23/2017 -
10/16/2017

OTSUKA PHARMACEUTICAL, JAPAN - 483 12/01/2017 - 12/31/2017
GENERAL MILLS, WEST CHICAGO, IL - EIR 483 04/09/2017 -
06/09/2017
GENERAL MILLS EIR 483
510K AC5 TOPICALGEL
GENERAL MILLS, JOPLIN, MO - EIR 483
GENERAL MILLS, WELLSTON, OH EIR 483 04/09/2017 - 06/09/2017
GENERAL MILLS, MILWAUKEE, WI - EIR 483
GENERAL MILLS , CARLISLE, IA - EIR 483
GENERAL MILLS, HANNIBAL, MO - EIR 483
PILGRIMS PRIDE CORPORATION, STALEY, NC MILLERCOORS LLC, EDEN
BREWERY, EDEN, NC ETC - 483
AUROBINDO PHARMA LTD, UNIT IV, INDIA - 483 02/12/2018 -
02/23/2018
COOK INCORPORATED, ELLETTSVILLE, IN - EIR 09/24/2010 -
10/05/2010
INDIVIDUAL RECS
K093910
INDIVIDUAL RECS
COSMETICS COMPLAINTS
RECS RE COFFEE CONCENTRATE AND COFFEE COLD BREW TESTS
01/01/2016 - 02/25/2018
RECS RE SITE INSPECTIONS, ETC
DR REDDY'S, SRIKAKULAM, INDIA - EIR 04/01/2017 - 02/26/2018
RECS RE COMPLAINT 17I00039
NDA 019-596 NDA 021-037
AUROBINDO PHARAM LTD UNIV IV INDIA - 483 02/01/2018 -
02/23/2018
AUROBINDO PHARMA UNIT IV, INDIA - 483 02/01/2018 - 02/26/2018
AUROBINDO PHARMA UNIT IV, INDIA 483 02/01/2018 - 02/26/2018
AUROBINDO PHARMA UNIT IV, INDIA 483 02/01/2018 - 02/26/2018

SUN PHARMACEUTICALS INDUSTRIES, HALOL, INDIA - 483 02/01/2018
- 02/23/2018
- 02/23/2018
- 02/23/2018
- 02/23/2018
- 02/23/2018
K170982 K112341 K163188 etc
NDA 16792
PEKANA-NATURHEILMITTEL GMBH, GERMANY - 483 10/01/2008 -
04/30/2013
BAXTER HEALTHCARE CORPORATION, DEERFIELD, IL - EIR 09/21/2016 -
09/28/2016
APPROVED FEED ASSAY METHODS RACTOPAMINE IN TYPE B AND TYPE C
MEDICATED FEED ETC 01/01/1980 - 02/26/2018
UFP TECHNOLOGIES NEWBURYPORT, MA - EIR, 483, ETC 02/01/2014 -
02/26/2018
US PHARMA LTD, MIAMI, LAKES, FL - INSPECTION REPORT 11/15/2017
- 02/26/2018
SAVIOR LIFETEC CORPORATION, TAIWAN - 483 11/01/2017 -
11/30/2017
FASCIABLASTER ADVERSE EVENTS
MUTUAL RECOGNITION AGREEMENT QUESTIONS 01/04/2016 - 02/26/2018

INGENUS PHARMACEUTICAL, SWITZERLAND - 483 10/01/2017 -
11/15/2017
ISOPROPYL ALCOHOL AERS 01/31/1969 - 01/31/2018
CORR BETWEEN FDA AND BASF FAP 2301 01/21/2017 - 01/03/2018
OLON RICERCA BIOSCIENCES, LLC, CONCORD, OH - 483, EIR
02/26/2014 - 02/26/2018
EPIPEN, EPIPEN JR FOIA REQUEST RECS 01/01/1900 - 02/26/2018

TRAMADOL AERS
K140635
NDA 019523
ANDA 202564
OUTBREAK LINE LIST SALMONELLA LINKED TO PISTACHIOS 12/01/2015 -
07/01/2016
K171269
ARSENIC, CADMIUM, LEAD TOTAL DIET STUDY DATA 10/01/2015 -
12/31/2017
BLICKMAN, INC, CLIFTON, NJ MAC MEDICAL, INC, MILLSTADT, IL
WHEELING, IL - 483 01/01/2012 - 02/26/2018
NDA 012750
MDR REPORT 6039447 NUMBER MW5065481 RECS
DEN170045
SUN PHARMACEUTICALS, HALOL, INDIA - 483 02/01/2018 - 03/06/2018

FOIA LOG ST JUDE MEDICACL 02/01/2018 - 02/28/2018
ANADA 100-237
K831000
NDA 203340
SUMMARY OF SAFETY AND EFFECTIVENESS P850035
K121166
2016-6969

ACLARIS THERAPEUTICS - ESKATA (HYDROGEN PEROXIDE) NDA 209-305
EXCLUSIVITY SUMMARY
PHARMEDIUM SERVICES LLC, TN, NJ, MS, TX - 483S 1/2717 TO 1/5/18

PARAGARD T 380A INTRAUTERINE COPPER CONTRACEPTIVE - AERS, MDRS
1/1/05 TO 2/10/10
MEDICAL WEST RESPIRATORY SERVICES LLC, ST LOUIS, MO - EIRS,
483S, WARNING LTRS 1/00 TO PRESENT
WOLTERS KLUVER, MEDI-SPAN - MEDICAL FOODS, DIETARY SUPPLEMENTS,
PRENATAL VITAMINS, ETC CORR 1/15 TO PRESENT
K101764, K932571
MITROGYNINE, 7-HYDROXYMITRAGYNINE, KRATOM - HHS ASSISTANT
SECRETARY OF HEALTH CORR
KATROM - RECS SUBMITTED BY VENABLE LLP 9/16 TO 11/16
INTERNATIONAL LABORATORIES LLC - CLOPIDOGREL TABS RECALL RECS

2016-7269
FOIA REQUESTS MADE TO HHS 1/17 TO PRESENT
DESHUM MEDICAL LLC - Z1 BLOWER K121374, HUMAN DESIGN MEDICAL
LLC - Z1 CPAP SYS K140929, ETC
2017-10250, 2017-10251, 2017-10535, ETC
DICUMAROL NDA 5-545, NDA 5-509 - CLNCL TESTING, LABELS, RVWS,
ETC
MOBERLY MEDICAL CENTER. MOBERLY, MO - INVESTIGATION RECS 3/15

LTR FROM DONALD KENNEDY TO CLIENTS OF INDUSTRIAL BIO-TEST
LABORATORIES INC 6/77
FCL HEALTH SOLUTIONS - IMPORT ALERT 89-08 ANALYTICAL RPTS, PI,
WEBSITE SCREEN SHOTS, ETC
ALLY MEDICAL SUPPLIES LTD - IMPORT ALERT 89-08 LBLG, ANALYTICAL
RPTS, IMPORT EXAMINATIONS, ETC
NEBRASKA GOVERNOR PETE RICKETTS, NEBRASKA ATTORNEY GENERAL DOUG
PETERSON, NEBRASKA DPET OF ADMINISTRATIVE SERVICES, ETC - CORR
9/1/17 TO 2/21/18
GOLYTELY - AERS
2016-7614
PULSE BIOSCIENCES - PULE TX SYS GLP ANIMAL STUDIES PRE-
SUBMISSION Q172050
KRATOM - RECS, RESEARCH, ANALYSIS, ETC
DUZALLO - SBA
DICUMAROL NDA 5-545/S017,S018,S016, ETC NDA 5-509/S005,S004

SANOFI - RIMONABANT TOXICOLOGY DATA RPTS
MEMO FROM THE SECRETARY OF HHS APPROVING THE DELEGATIONS OF
AUTHORITY SET OUT IN FDA STAFF MANUAL GUIDE
CORR FROM BRAT TO ROBERT CALIFF, REPRESENTATIVES REGARDING
MIFEPRISTONE, FDA CONGRESSIONAL LIAISON
EISAI - ARICEPT PATCH RECS
PHILIP MORRIS USA - SE0004288, SE0004307, SE0004308, ETC
SUBSTANTIAL EQUIVALENCE RPTS
GE OEC MEDICAL SYS - FLUOROSCOPIC X-RAYS C-ARM CLOSE OUT LTR

2016-10008
FAIRLIFE, COOPERSVILLE, MI - CMPLNTS, RENEWAL APPLICATIONS,
ENFORCEMENT RECS, ETC
3-V DAIRY, ROSWELL, NM - PERMITS, REGISTRATIONS, WARNING LTRS,
ETC
PULSE BIOSCIENCES - EFS PRE-SUBMISSION Q171460
PULSE BIOSCIENCES - K170774
COMMUNICATIONS WITH MANUFACTURERS OF WEN 01/01/2008 -
02/22/2018
COMMUNICATIONS ON BEHALF OF CONCERNED CITIZENS RE WEN
01/01/2008 - 02/22/2018
SCOTT LEE, MD, SEATTLE, WA - 483, EIR, CORR 09/03/2013 -
10/03/2013
SANOFI, ITALY - 483 7/29/16
RECS RE NEOCATE INFANT DHA/ARA ETC
MAUDE REPORTS HERNIA SURGICAL MESH PRODUCTS PARIETEX, SYMBOTEX
ETC, OSB REVIEWS
NEXGEN PHARMA, IRVINE, CA - 483 10/20/2017 - 10/20/2017
K001350 K001374
ACTION PACKAGES NDAS
ACTION PACKAGES NDAS

DRUG RECALL ENFORCEMENT REPORTS 01/01/1990 - 12/31/2011
AKORN, DECATUR, IL - 483 01/01/2016 - 02/27/2018
FY2017 Annual FDA Medical Device Quality System Data
COREY ERICKSON, CLINTON, UT - EIR, 483, CORR 09/15/2010 -
09/17/2010
AERS DOCUSOL, ETC
ANDA 065146 ANDA 065412 ANDA 064156 ETC BIOEQUIVALENCE RVWS
MARK DIBUONO, RICHMOND BEHAVIORAL ASSOCIATES, STATEN ISLAND, NY
- EIR, 483, CORR 11/13/2008 - 12/22/2008
JERRY MITCHELL, TEXAS CENTER FOR DRUG DEVELOPMENT, INC,
HOUSTON, TX - 483, EIR, CORR 05/19/2011 - 05/25/2011
JAMES REEVES, JR, FORT MYERS, FL - EIR, 483, CORR 08/29/2011 -
09/16/2011
MDR Report Key 7224448 and Number MW5074915
AKORN RECS 02/27/2016 - 02/27/2018
JAMES ATKINS, SOUTHEASTERN MED ONC CENTER, GOLDSBORO, NC -
EIR, 483, CORR 09/16/2014 - 09/25/2014
DR REDDY'S CTO VI UNIT, INDIA - 483 02/01/2018 - 02/28/2018
RECS RE MEETING TRUTH INITIATIVE, FDA NEW COMPREHENSIVE PLAN
FOR TOBACCO AND NICOTINE REGULATION
RECS RE MEETING CAMPAIGN FOR TOBACCO FREE KIDS FDA NEW
COMPREHENSIVE PLAN FOR TOBACCO AND NICOTINE REGULATIONS
K140669
NDA 017851
LOUIS FEHRENBACHER, KAISER PERMANENTE MEDICAL CENTER, VALLEJO,
CA - EIR, CORR, 483 8/11/16
K161201
NAMES OF REFERENCE LISTED DRUGS SUBJECT OF FINAL COMPETITIVE

GENERIC THERAPY DETERMINATIONS 21 USC 356h(b)(4)
NDA 016084
NDA 018669
AUROBINDO UNIT 12 - 483 02/19/2018 - 03/01/2018
RECS RE TESTING FOR ASBESTOS IN TALCUM POWDER 01/01/1975 -
02/28/2018
MCKESSON CORPORATION CONTRACTS ETC TIRF REMS
CSPC ZHONGNUO PHARMACEUTICAL CO LTD, CHINA - 483 03/23/2015 -
03/27/2015
INSPECTION LIST
PHARMACIA & UPJOHN COMPANY, LLC, KALAMAZOO, MI - EIR, 483, CORR
12/22/17
EMICIZUMAB AERS
TRIMED INC, SANTA CLARITA, CA - EIR, 483, CORR 11/17/17
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC, WALTHAM, MA
- EIR, 483, CORR
NEUROTRONICS, INC, GAINESVILLE, FL - EIR, 483, CORR 11/15/17

MYLAN, BIOCON CRL MYL-1401H
2018-866 2018-1065 2018-1168 ETC
MAUDE REPORTS
NORTHWESTERN UNIVERSITY IRB - INSPECTION RECS 08/01/2008 -
02/28/2018
NCT 03361748 PROTOCOL
FOIA REQUEST LOGS DEC 2017
SANOFI, ITALIA - 483 9/26/14
CAFFEINE AERS
BIOCON, MALAYSIA - 483 02/01/2018 - 02/28/2018
LIST OF INSPECTIONS FEB 2018
JM HUBER, QUINCY, IL - EIR 9/17
ENZYME DEVELOPMENT CORP, SCRANTON, PA - EIR 8/17
LIST OF INSP INDICATING IF A 483 WAS ISSUED TO BUSINESSES
OFFERING DIRECT TO CONSUMER STEM CELL TREATMENTS 1/02 TO
PRESENT
ZERBAXA (CEFTOLOZANE/TAZOBACTAM) - TEMPORARY HSPCS C CODE
APPLICTION
MOBI C CERVICAL DISC PROTHESIS - PMA
2017-7328
NAVAL ORDINANCE LABORATORY - REMODEL RECS
PARIETEX - COMPOSITE HERNIA MESH COVIDIEN - PROGRIP
LAPAROSCOPIC SELF FIXATING HERNIA MESH CORR
LIBRAX (CHLORIDIAZOPOXIDE HYDROCHLORIDE & CLIDINIUM BROMIDE) -
DOCS
TEVA PHARMS - ANDA 90-713 SAGENT PHARMS ANDA 04--289 ANDA 05-
870 ETC
2017-2692, 2017-289, 2017-3974, 2016-631, 2015-7518, 2015-4388,
2015-3088, 2015-1945
K170784
ATTACHED REQUEST
VANILLA SILQ, VANILLA SILQ HD, VANILLA SILQ MD AERS
MED-PHARMEX, PAMONA, CA - EIR, 483 01/01/2018 - 03/01/2018
SYN-TECH CHEMICAL & PHARMA CO LTD, TAIWAN - 483, EIR 01/01/2015
- 02/28/2018
RILUZOLE, TETRABENAZINE SBA ETC
2017-3554
NDA 208090 UNREDACTED CMC REVIEWS
TOQUE SNUFF LIMITED - SUBMISSIONS, CORR ETC FIRST PARTY
CCM PACKAGING, INC, HIAWATHA, IA - EIR 12/10/2016 - 03/01/2018

TOQUE SNUFF LIMITED - INTERNAL RECS (FIRST PARTY)
ALBIE'S FOODS, INC, GAYLOR, MI - INSPECTION RECS 01/01/2014 -
03/01/2018
NDA 125166 SBA
NDA 202379 S007
LAURUS LABS PRIVATE, LIMITED, INDIA DISCH AG, SWITZERLAND

ALMAC PHARMA SERVICES LIMITED, UK - 483 11/28/2016 - 09/08/2017
SIEGFRIED EVIONNAZ SA, SWITZERLAND COSMACEUTICAL RESEARCH
LABORATORY INC, CANADA TAKEDA, JAPAN - 483 08/29/2011 -
09/23/2016
DMF SPREADSHEET
2017-3553
SPREADSHEET OF WARNING LETTERS 10/01/2001 - 02/28/2018
NDA 017042
AZTECA MILLING LP, HENDERSON, KY TREEHOUSE PRIVATE BRANDS, INC
ETC 483 01/12/2017 - 08/18/2017
RECS RE PHASE MODELING SOFTWARE 01/01/2018 - 02/20/2018
CASES 6226292 6235927 6346333 ETC
QUESTIONS RE CONTRACTS
NDA 018651
2017-10160
SMITH & SONS SEAFOOD, INC, DARIEN, GA ETC - 483 01/31/2017 -
11/15/2017
ENBREL AERS
FCN 975
CASES 8394211 9063770 9166804 ETC
LETTER FROM OCEAN SPRAY
CHUGAI PHARMACEUTICAL, JAPAN - 483 09/01/2017 - 09/30/2017
2017-10016
THE NEIL JONES FOOD COMPANY, FIREBAUGH, CA ETC - 483 06/22/2015
- 05/26/2017
BIOCON, INDIA - EIR 08/16/2016 - 11/16/2016
OFFICE OF FOOD ADDITIVE SAFETY ANALYTICAL METHODS 01/01/1998 -
03/01/2018
FCN 618
2017-2520
AUROBINDO PHARMA, HYDERABAD, INDIA - 483 02/01/2018 -
02/28/2018
HYDROCODONE, OXYCODONE AERS
HEMLIBRA AERS
ETEPLIRSEN AERS, CASE REPORTS 09/19/2016 - 03/07/2018
EXPAREL 2 CASES
FAERS 13404434
DACLATASVIR AERS
ESSURE FOIA REQUESTS 2002-PRESENT
GLAXOSMITHKLINE, RESEARCH TRIANGLE PARK, NC - 483 08/20/2007 -
11/13/2007
2017-1747
COMPLAINT RECS 09/09/2017 - 03/02/2018
J PLASMA DEVICE AERS
NDA 021060
PBT2 RECS RE PARTIAL CLINICAL HOLD
NDA 005545
NDA 005545 NDA 005509
PHARMCO LABORATORIES, INC, TITUSVILLE, FL - 483 11/02/2015 -
01/01/2016
NDA 021060
DARWIN'S NATURAL PET PRODUCTS, INC, TUKWILA, WA - EIR,
ATTACHMENTS 01/01/2016 - 12/31/2017
NDA 016807 SAFETY AND EFFECTIVENESS DATA
FHHSF223200850020I, Task Order HHSF22301005T
ORANGE BOOK PATENT LISTING DISPUTE RECS
CORR RE MEETINGS WITH MADRES TOMES
BAYER OY, TURKU, FINLAND MEDILINK HOSPITAL AND RESEARCH
CENTER, INDIA TEVA PHARMACEUTICAL INDUSTRIES, LTD - 483
04/11/2016 - 10/13/2017
ANDA GENERTIC DRUGS
Correspondence between CDER and LPA regarding achondroplasia.

NDA 208558/S-001
RECS RE TEVA CEASE MANUFACTURE MEBENDAZOLE
NDA 205552/S-017
BLA 125514/S-14
2016-10217
COMPLAINTS, RECALLS, ETC RE FLISCHIE CLIPS 01/01/2000 -
09/12/2015
VIAGRA, CIALIS, LEVITRA AERS
TELIGENT, IGI LABS FOIA REQUESTS 01/01/2015 - 03/02/2018
ZYFLO CR LABEL
K113658
K123803
P9700934
CORR RE ESSURE
AXOGEN, DAYTON, OH BURLESON, TX ALUCHUA, FL - INSPETION
REPORTS 01/01/2015 - 03/02/2018
PREVIOUSLY RELEASED 483, RESPONSE, EIR FEB 2018
HUMIRA AERS
RED VINE LICORICE, LA PORTE, IN - INSPECTION RECS 01/01/2018 -
03/04/2018
CIPLA, INDIA - 483 01/01/2018 - 01/31/2018
YESCARTA KYMRIAH SUMMARY BASIS OF REGULATORY ACTION
DR REDDY CTO VI, INDIA - EIR 03/01/2017 - 03/01/2018

EMAILS WITH OCI
OSMOLEX ER REVIEW RECS
ADVERSE EVETS ZELTIQ, ALLERGAN
TEVA, CINCINNATI, OH - EIR 01/01/2018 - 03/01/2018
K113282 K072397
KIMBERLY CLARK PATENT WARNING SYSTEM MODEL 1000 510K
K043342
LIST OF 483S 01/01/2018 - 02/28/2018
NADA 141-423 TOXICOLOGY STUDY
ZONALON APPROVAL RECS
THOMAS COFFEE COMPANY, ST LOUS, MO - INSPECTION RECS
01/01/2009 - 03/05/2018
KRATOM WARNING LETTERS 03/05/2008 - 03/05/2018
FAERS 14273488 HEMLIBRA
ZIMMER BIOMET, WARSAW, IN - EIR, 483, CORR 01/26/2018 -
03/05/2018
OSELTAMIVR AERS
AUROBINDO UNIT 12, SUN PHARMA, HALOL, INDIA - 483 02/01/2018 -
03/05/2018
Q LABORATORIES INC, CINCINNATI, OH - EIR 06/10/2010 -
11/18/2016
ST JUDE MEDICAL WARNING LETTER RECS 01/01/2016 - 03/05/2018
CIPLA LIMITED, VASCO DA GAMA, INDIA PFIZER PHARMACEUTICALS, PR
- 483 01/01/2018 - 01/31/2018
LETTER FROM PAUL D PARKMAN 10/31/86
RECS CREATION OF OTC HEARING AID CATEGORY 01/01/2017 -
03/05/2018
BIOMERIEUX, INC, DURHAM, NC - EIR 04/03/2017 - 04/10/2017
CARDIOVASCULAR SYSTEMS, INC PEARLAND, TX ST PAUL, MN - EIR,
CORR, 483 03/05/2015 - 03/05/2018
MEDWATCH REPORTS
COMPOUNDING PHARMACIES REGISTERED IN NEW MEXICO
NDA 208552
NDA 015921
PROTAMINE AERS
DAEWOONG BOTULINUM TOXIN PLAN SOUTH KOREA - 483, EIR
11/01/2017 - 12/21/2017
NDA 019183
THERMOGRAPHIC DEVICES AERS
LIST OF GRANT AWARDS TERMINATED BY THE FDA 2017
BLA 761058
JANSSEN PHARMS - PALIPERIDONE EXTENDED-RELEASE TABS NDA 21-999
PHARMACOLOGY RVW PAGES 170-175
AKORN, DEKATUR, IL ETC - WARNING LETTER, 483 06/01/2017 TO
PRESENT
2015-5170
NDA 021196
GEL SPICE INC - REST RESULTS, COMMUNICATIONS, ETC 07/15/2016
TO PRESENT
NDA 005545 NDA 005509
FDA MAMMOGRAPHY FACILITY DATABASE DATA 01/01/2014 - 12/31/2017

BLA 761064 SBA
PRILOSEC - ISRS 4769158, 4863177, 5062092, ETC
MERIT MEDICAL SYSTEMS, MALVERN, PA - EIR
K171037
ADVANCED STERILIZATION PRODUCTS, IRVINE, CA - 483 08/01/2008 -
03/01/2018
ORPHAN DRUG DESIGNATION RECS EVEROLIMUS
K133924
ORPHAN DRUG DESIGNATION RECS LANREOTIDE
NALOXONE AERS
AKORN 483 01/01/2017 - 03/06/2018
COOK INCORPORATED, ELLETTSVILLE, IN - EIR 11/30/2005 -
12/06/2005
US-FDA-361920 F132306621
ADVANCED STERILIZATION PRODUCTS, IRVINE, CA - EIR 03/01/2008 -
03/01/2018
GEMTUZUMAB OZOGAMICIN ORPHAN DRUG INFORMATION
2011-0591 2012-5077 2012-6315 ETC
2013-5061
STRYKER SHAPEMATCH CUTTING GUIDE RECALL RECS
K781892K911886K953277ETC
PAUL E DANCHELL A/S, DENMARK - EIR FIRST PARTY 08/09/2017 -
08/11/2017
MC RESOURCE DEVELOPMENT DBA PINE VALLEY SPRINGS, NEW RINGGOLD,
PA- 482, COMPLAINT, CORR
ANDA 071208
JEROME GOLDSTEIN, SAN FRANCISCO, CA - INSPECTION RECS, FEI
NUMBER
TRIPLE T SPECIALTY MEATS INC - MULTISTATE OUTBREAK OF
SALMONELLA TYPHIMURIUM LINKED TO CHICKEN SALAD
NDA 208144
K952882, K973873, K964554
INDIVIDUAL RECS
BRAINTREE LABORATORIES INC, HOLBROOK, MA RANDOLPH, MA - EIRS
12/16
ACLARIS - ESKATA TOPICAL SOLUTION NDA 209-305 EXCLUSIVITY
SUMMARY
ORTHOPEDICS AND REHABILITATION DEVICES ADVISORY PANEL - NORIAN
SRS BONE CEMENT TRANS 10/9/98
PHILIP MORRIS USA INC - SE0014203 REVIEWER SUMMARIES
MEDICAL USE CASES FOR CANNABIS
BIOMARIN PHARMS - BRINEURA ORPHAN DRUG DESIGNATION
CORR BETWEEN FDA AND ACADIA PHARMACEUTICALS RE UNUSUAL ADVERSE
EVENTS NUPLAZID
PEREGRINE SURGICAL LTD, NEW BRITAIN, PA - EIR, 483 7/15/10
2016-2253, 2016-5994, 2016-6058, 2016-6059, 2018-1911
EMAILS AND CORR TO AND FROM SCOTT GOTTLIEB CONTAINING THE WORD
KRATOM
VENTOLIN RECS RE HARMFUL EFFECTS, ADVERSE EVENTS 12/20/2015 -
12/20/2017
FOIA REQUESTS SUBMITTED BY AMEET SARPATWARI ETC
LETTER FROM CFSAN TO AMAZON LEXINGTON, KY JULY 2008 FAILURE TO
REGISTER
NUMBER OF NDA SUBMITTED AND APPROVED FY17
RECS RE FOODS IDENTIFIED AS ADULTERATED WITH DIETHYLHEXYL
PHTHALATE 01/01/2011 - 03/06/2018
SUN PHARMACEUTICAL LIMITED, HALOL, INDIA - 483 09/08/2014 -
09/19/2014
EMAILS SENT, RECEIVED MITCHELL MATHIS RE NUPLAZID,
PIMAVANSERIN, ACADIA 11/01/2015 - 06/01/2016
RECS RE MANNOSE, IND

KRATOM EIGHT PANEL ANALYSIS 01/01/2016 - 01/01/2018
REC RE BOTTLED DRINKS MANUFACTURES, SOLD DISTRIBUTED BY
LASSONDE PAPPAS & CO, 7-ELEVEN 01/01/2013 - 03/06/2018
EYLEA ISR
K120009 K151986
Orphan drug information for phenylbutyrate
Orphan drug designation information for treprostinil
COVANCE, DAYTONA, FL - DALLAS, TX - EIR, RESPONSE, ETC
EBRAHIM DELPASSAND, HOUSTON, TX - INSPECTION RECS 01/14/2015 -
06/05/2015
PHILIPS HEALTHCARE, CLEVELAND, OH - 483 07/01/2014 -
02/12/2018
NDA WITHDRAWN BY APPLICANT 01/01/2000 - 12/31/2016
ALERE INC - INRATIO PT/INR MONITOR, INRATIO2 PT/INR MONITOR,
INRATIO PT/INR TEST STRIPS, ETC TESTING, RECALL RECS, EIRS,
483S, ETC
ANDA73458 ANDA75209
FOIA DAILY LOG 01/15/2018 - 03/07/2018
Dantrolene orphan drug designation information
Mercaptorpurine orphan drug designation information
Nimodipine orphan drug information
K152948
NDA 207962
NDA N209501
LIST OF ERRORS 5/27/16 FINAL RULE RE REVISION OF NUTRITION AND
SUPPLEMENT FACTS LABEL
RECS UNITED SAFETY AGENTS FSVP IMPORTER 01/01/2018 - 03/07/2018

INDUSTRIAL CHEMICAL LLC, INI BOTANICALS INC - MITRASAFE NDIN
994 CORR, NOTES, SUBMISSIONS, ETC
Cysteamine orphan drug designation information
HEMOCUE IMPORTER RECS 01/01/2015 - 03/07/2018
THE MERIDIAN BIOSCIENCE, INC, CINCINNATI, OH - RECS RE OP ID
68932
AKORN PHARMACEUTICALS COMM WITH FDA RE DEVELOPMENT OF
OPHTHALMICS 01/01/2016 - 03/07/2018
K940277 FIRST PARTY
NDA 208910
ARBOR PHARMS - ERYTHROMYCIN GRANULES FOR SUSPENSION NDA 50-207
SBA
VOLUNTARY CONSMETIC REGISTRATION PROGRAM (VCRP) - USE TOTALS,
INGREDIENT, CATEGORY TOTALS, ETC
CLOSED FOI REQUESTS 2/5-9/18
ANDA 208532
RECS RE CLUSTER OF SALMONELLA NEWPORT WASHINGTON, OR PRECUT
FRUIT OR MELON 10/25/2018 - 03/07/2018
PRILOSEC AERS
ACETAMINOPHEN PREPARATIONS - ISRS11557734, 11568828, 11727667,
ETC
CAP WM WRIGLEY JR COMPANY
BE review of ANDA 078340
BE review for ANDA 079179
K961735
K032465
Octreotide orphan drug information
Benefix orphan drug information
NITTO AVECIA PHARMA SERVICES, INC, IRVINE, CA - EIR 04/19/2017
- 04/21/2017
SUMO BISCUITS PVT LTD - PRODUCTS DELIVERED TO DOW AT THE NEWARK
PORT BTWN 1/1/16 AND 9/30/16 RECS
K170825
TRIPLE T SPECIALTY MEATS, INC, IOWA - EMAIL, CORR, ETC
01/01/2018 - 03/08/2018
AUROBINDO PHARMA, PENEM, INDIA - 483 03/01/2018 - 03/08/2018

MEMO OIA ALTAF LAL 05/01/2014 - 06/01/2014

SUN PHARMACEUTICAL INDUSTRIES, INDIA - 483 01/01/2017 -
06/30/2017
CORD BLOOD APPROVAL 03/01/2013 - 03/05/2015
DMF OCREVUS
K171158
EIRS RELEASED 02/01/2018 - 02/28/2018
FENFLURAMINE - MEDICAL AND SCIENTIFIC EVALUATION REGARDING
SCHEDULING UNDER THE CONTROLLED SUBSTANCES ACT (CSA)
483 RELEASED 02/01/2018 - 02/28/2018
Mononine orphan drug designation information
UNIVERSAL BEAUTY PRODUCTS INC, BENSENVILLE, IL - 483 10/16/2017
- 12/04/2017
UNIVERSAL PACKAGING SYSTEMS, INC, BATAVIA, OH - 483 11/27/2017
- 11/30/2017
DAEWOONG, KOREA - FMD 145 1/01/2018 - 03/08/2018
OUTBREAK LINE LIST ILLNESS MULTISTATE OUTBREAK OF SALMONELLA
TYPHIMURIUM LINKED TO CHICKEN SALAD 01/01/2018 - 03/08/2018
RECS RE MULTISTATE OUTBREAK OF SALMONELLA TYPHIMURIUM LINKTED
TO CHICKEN SALAD TRIPLE T SPECIALTY MEATS INC IN IOWA
01/01/2018 - 03/08/2018
VERNON PACKAGING INC, MOUNT VERNON, NY - 483 11/06/2017 -
11/08/2017
Histrelin orphan drug information
CASE 14273488 HEMLIBRA
ORTHOSOFT INC (DBA ZIMMER CAS) - X-PSI KNEE SYS K171269
BK160087
INFLUENZA VACCINATION VAERS
PHYSIO-CONTROL, INC, REDMOND, WA - 483 11/27/2017 - 12/15/2017

PHARMALUCENCE, INC, BILLERICA, MA - 4383 10/25/2017 -
11/13/2017
PHARMACIA & UPJOHN COMPANY, LLC, KALAMAZOO, MI - 483 12/18/2017
- 12/22/2017
PHARMACEUTICAL LABORATORIES INC, ADDISON, IL - 483 09/18/2017
- 10/10/2017
List of 483s issued in February 2018
Fludarabine phosphate orphan drug information
Interferon beta-1a orphan drug information
K173101
SANDOZ INC - DOCETAXEL INJ NDA 201-525 LBLG, RVWS, SAFETY
ALERTS, ETC
K173420
K171295
K172113
NATIONAL ADVERTISING DIVISION CASE ALLERGAN V. SYNERGY
PHARMACEUTICALS ETC
RECS RE CC 152621
Orphan drug information for amphotericin
Avonex orphan drug information
Sotalol HCl orphan drug designation information
ANDA 074646 ANDA 070733
Bendeka orphan drug information
NDA 201-525 CORR ASSOCIATED WITH PRISCILLA CAZAYOUX
COMPLIANCE PROGRAM GUIDANCE MANUAL DIETARY SUPPLEMENTS
FAERS 7372770 7400426 7400981 ETC

Orenitram orphan drug information
K171655
NY GOURMET, BROOKLYN, NY - LISTERIA CHICK PEA SALAD 4/10
GENENTECH - ACTEMRA (TOCILIZUMAB) SUMMARY RVW
GRANT 1U18FD006259-01 1U18FD004662-01
COMPLIANCE POLICY GUIDANCE MAUNAL
TOZADENANT - RECS
ACCIDENT FOOTAGE WHITE OAK CAMPUS 2/2/18
PACIFIC BIOLABS, HERCULES, CA - EIR 10/17
LESAGE NATURAL WATER, LESAGE, WV - WARNING LTR, INSP SINCE 2015
AER RELATED TO MULTIPLE SCLEROSIS TREATMENTS

FCN 1528
SAVAGE RIVER INC - BEYOND MEAT INVESTIGATION
ALLERGAN, McGHAN, MENTOR - BREAST IMPLANTS PMA
ANGIO DYNAMIC INC - NANO KNIFE SYS EAP DESIGNATION
POROUS COATED ACETABULAR COMPONENTS K050124
MALLORY HEAD TOTAL HIP SYS K030055
RANAWAT BURSTEIN TOTAL HIP SYS K921277
DR REDDYS MEDAK INDIA - 483 03/01/2018 - 03/09/2018
K965252
K021737
BLA 125487 orphan exclusivity information
NDA 207916 EXCLUSIVITY RECS
NDA 209279 orphan exclusivity information
FAERS 12818381 12869640 12884448 ETC
FCN No. 907
NDA 022122 S11
WANBURY LTD, INDIA - 483 02/26/2018 - 03/02/2018
JOHNSON FOODS, INC, SUNNYSIDE, WA INSPECTION RECS 01/01/2011 -
12/31/2017
NDI 792
SPARK THERAPEUTIC, WEST PHILADELPHIA, PA - 483S 1/17 TO PRESENT

FDA RECS RE UNCLAIMED, UNCASHED CHECKS ETC 03/01/2012 -
03/01/2018
DR REDYY'S LABORATORIES LTD, INDIA - 483 03/05/2018 -
03/09/2018
DR REDDY INDIA - 483 03/02/2018 - 03/09/2018
ANDA 091071 SBA
K940466
ANDA 202103
Epaned Kit orphan drug information
AMERICAN SUGAR REFINING INC, YONKERS, INC BACTOLAC
PHARMACEUTICAL, INC, HAUPPAUGE, NY ETC 483 06/10/2015 -
12/21/2017
Wilate orphan drug information
Gralise orphan drug information
KITE PHARMA, EL SEGUNDO, CA - 483S 1/17 TO PRESENT
FAERS 13227018 13227014 12137564 ETC
DAF File 09159
FAERS 127457131, 127457181, 130224481, ETC
INDIVIDUAL RECS
FAERS 9630010 9294895 9935589 ETC
PREVIOUSLY RELEASED UNTITLED LETTERS 01/01/2000 - 03/12/2018
FAERS 9630010 9294895 9935589 ETC
TIN MOON LABS CORP, DIGITAL CANAL CORP, DUBUQUE, IA - DRUG
SAFETY ISSUES
EXTENDED RELEASE AND LONG ACTING OPIOD RISK EVALUATION AND
MITIGATION STRATEGY (REMS) 6/21/13
SUVEN LIFE SCIENCES, TELANGANA, INDIA - 483 2/18
CELLTRION INC, KOREA - EIR 05/01/2017 - 12/21/2017
PUMA BIOTECHNOLOGY - NERLYNX (NERATINIB) MEDICATION ERROR RPTS
1/17 TO PRESENT
JANSSEN PHARMACEUTICALS INC - INVOKANA, INVOKAMET, INVOKANET XR
AERS, 15-DAY ALERTS
ZELTIQ AESTHERICS INC - COOLSCULPTING K160259 APRVL RECS
ZELTIQ AESTHETICS INC - COOLSCULPTING K142491 APRVL RECS
PUBLIC A/C MTG RELATING TO HYDROCODONE COMBINATION PRODUCTS -

MINS, RECS COMMENTS RELATED TO THE 2014 RESCHEDULING OF
HYDROCODONE COMBINATION PRODUCTS FROM SCHEDULE III TO SCHEDULE
II
VAPING - MEDICAL RESEARCH, TEST RESULTS
SORIN STOCKERT 3T HEATER-COOLER INCIDENT RPTS
CNEP SLEEP THERAPY SYS - FDA FEEDBACK FOR Q141094
SANOFI, REGENRON PHARMS - DUPIXENT (DUPILUMAB) AERS, MEDICATION
ERROR RPTS 4/1/17TO PRESENT
GOCOVRI EXTENDED RELEASE CAPS NDA 208-944 REGULATORY
EXCLUSIVITY
ARICEPT, DONEPEZIL - AERS
AVYCAZ NDA 206-494 - GRANTING OR DENIAL OF MARKET EXCLUSIVITY

CLNCL TRIAL RECS
2016-478 2016-974 2016- 1416 2016- 1626 2016- 4289 2016-

4487 2016- 5090 2016- 5301 2016- 5546 2016- 5738 2016- 6861
2016- 8426 2016- 8448 2016- 8588 2016- 8685 2016- 8710 2016-
8727 2016- 9036 2016- 9040 2016- 9099 2016- 9205 2016- 9215
VITAROS COMPLETE RESPONSE LETTER

Steritalc orphan exclusivity information
VIGIV orphan exclusivity information
K142432
NDA 009176
NOVARTIS, MORRIS PLAINS, NJ - 483S 1/17 TO PRESENT
Norditropin orphan exclusivity information
Nutropin Depot orphan exclusivity information
ENERGIST LTD 510K NEOGEN 510K
NDA 19640 ORPHAN DRUG EXCLUSIVITY
Orphan exclusivity information for NDA 206356
K173388
K962485
NDA 022399 S 005
ACERTA PHARMA GCP, REDWOOD CITY, CA - EIR 08/01/2017 -
08/30/2017
BLA 103471/S-5189 CMC
MERCK - INSP 5/22-26/17
WOCKHARDT/MORTON GROVE PHARMACEUTICAL, MORTON GROVE, IL - EIR
01/01/2016 - 12/31/2016
A list of all sites where the FDA conducted GMP, GMP, or GCP
inspections during January and February 2018
BIOTEC, BADDI, INDIA - 483 12/01/2017 - 12/13/2017
FORTEO AERS
K172890
INNOVATION STERILIZATION TECHNOLOGIES, LLC, DAYTON, OH -
INSPECTION RECS
HOSPIRA SODIUM BICARBONATE 2% SIDE EFFECTS
MUPIROCIN CALCIUM CREAM 2%, DOXEPIN HCL CREAM 5% ETC - APPROVAL
RECS
Orange Book Cumulative Supplement for January 2010
AKORN, DECATUR, IL HILMALCHI PRADESH, IN - 483 2017-2018
CHROMADEX - RECS 4/1/08 TO 4/1/2015
PEAR THERAPEUTICS INC - COMPUTERIZED BEHAVIORAL THERAPY DVC FOR
PSYCHIATRIC DISORDERS DE NOVO APPLICATION 5/16/16, Q-
SUBMSISSION MTGS, ETC
FDA'S CURRENT DOCUMENT RETENTION POLICY
BELLUS MEDICAL - SKINPEN PRECISION SYS DE NOVO APPLICATION AND
DE NOVO DECISION SUMMARY
ALKERMES PLC - VIVITROL AERS, STUDIES, STATISTICS, ETC
ALKERMES PLC - VIVITROL STUDY 2009
EARTH ANIMAL - NO HIDE DOG TREATS INVESTIGATION RECS
ARZA RAZA MD, RUSH PRESBY ST LUKES MED CTR - INSPS,
INVESTIGATIONS, SANCTIONS, ETC
BLA 125166/S-422
Manufacturers and importers of tobacco products for which a

user fee was received during the second quarter of fiscal year
2018, Manufacturers and importers of tobacco products for which
a user fee was assessed during the second quarter of fiscal
year
TESTING DATA CHICKEN SALAD OUTBREAK
ALPHAGAN (BRIMONISINE TARTRATE) NDA 20-490 - RVWS, OCULAR
DISTRIBUTION AND TOXICOKINETIC DATA I ANIMALS AND DAFETY
PROFILE OF THE DRUG IN HUMANS
K171442
K172399
K153754
EMAILS TO, FROM COMMISSIONER SCOTT GOTTLIEB RE VECTOR, LORBER,
BROWNSTEIN 05/09/2017 - 03/13/2018
FDA POSITION ON SYNTHETIC BOTANICALS CONSTITUTING NEW DIETARY
INGREDIENTS
FOIA REQUESTS RE OUTBREAK 01/01/2018 - 03/13/2018
CORR, RECS RE G-2897 RE MONESIN
MITRE CORP - AWARD HHSSF22320160236W
SAFC, CARLSBAD, CA - 483 03/14/2016 - 03/12/2018
PRODUCT TAMPERING
JIANGSU YUNYANG PHARMACEUTICALS GROUP CO LTD - REGISTRATION
RECS 06/11/2015 - 06/11/2015
EMAILS KHEMRY MIN, MATTHEW HOLMAN, NATHAN HURLEY RE VECTOR,
LORBER, BROWNSTEIN ETC 01/20/2017 - 03/13/2018
MEMOS PREPARED BY CDER EXCLUSIVITY BOARD GOCOVRI 05/01/2017 -
03/13/2018
K060888
NDA 190523
OSSUR, TIJUANA, MEXICO - EIR, 483, ETC
AUROBINDO UNIT IV, INDIA - 483 01/01/2018 - 03/01/2018
DEXCOM, SAN DIEGO, CA PHOENIX, AZ - EIR, 483, ETC 1/1/17 TO
PRESENT
NDA 20007
K152721
WASHINGTON DC VA MEDICAL CENTER - INSPECTION RECS 02/07/2018 -
03/13/2018
NDA 207202
MICROMO ELECTRONICS INC, CLEARWATER, FL - EIR 01/01/2014 -
03/13/2018
XIMEA, GERMANY, LAKEWOOD, CO - EIR MOST RECENT 01/01/2014 -
03/13/2018
NDA 203214
NDA 008453 NDA 008845
NUPLAZID 13867856 13771329 13998937 ETC
AMPHENOL ALDEN, MEXICO BROCKTON, MA - EIR MOST RECENT
01/01/2015 - 03/13/2018
SUN PHARMACEUTICALS, HALOL, INDIA - 483 01/01/2018 - 03/01/2018

ORANGE BOOK RECS 01/01/2003 - 03/14/2018
K171120
K170239
MORPHABOND EXCLUSIVITY MEMO, ADDENDUM TO MORPHABOND
EXCLUSIVITY MEMO
INDIVIDUAL RECS
INDIVIDUAL RECS
RECS RE CC 150948
POLYMER CONVERSIONS INC, ORCHARD PARK, NY - EIR, 483, RECALLS
03/27/2013 - 03/16/2018
2017-10376
EVOXAC, SALAGEN MASTER FILES
LOPERAMIDE FAERS 14314641 14290863 14253039 ETC

XARELTO (RIVAROXABAN) TABS - EFFECT ON CHOLESTEROL LEVELS,
WEIGHT GAIN
2012-565, 2012-1687, 2012-1988, 2012-453
INDIVIDUAL RECS
ANHUI PHARMACEUTICALS CO LTD, CHINA REGISTRATION RECS
10/10/2015 - 10/10/2015
FOI DAILY LOG 9/27/17 TO PRESENT
LIST OF COMPANIES THAT HAVE REQUESTED BREAKTHROUGH THERAPY
DESIGNATION 2018 TO PRESENT
LIST OF FOI REQUESTS MADE BY BRIDGER MANAGEMENT AND RIDGEBACK
CAPTIAL MANAGEMENT LLC 6/1/17 TO 3/1518
DR REDDY'S, MEDAK, INDIA - 483 02/01/2018 - 03/31/2018

PAXIL AERS 01/01/1999 - 12/31/2007
DKT 78N-0301 DKT 78N-0301
SANOFI PASTEUR LIMITED, NORTH YORK, CANADA GENENTECH, INC,
VACAVILLE, CA TS FOOD INDUCTRY SDN, MALAYSIA ETC 483
08/06/2001 - 09/22/2017
CANAGLIFLOZIN, EMPAGLIFLOZIN, DAPAGLIFLOZIN ETC AERS
MIDAZOLAM AERS FAERS

SAMPLE 1018979 COMPLAINT 150195 RECS
NUTRI BIOTIC, LAKEPORT, CA - REGISTRATION RECS 03/10/2016
OTC Volume 120019 and page 16 from OTC Volume 120033 Docket
80N-0050 Anorectal Drug Product Monograph 5/27/80
ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD. (JBS), CHINA TOSHIBA
MEDICAL SYSTEMS CORPORATION, JAPAN PHILIPS GOLDWAY, CHINA ETC
- 483 07/27/2015 - 07/20/2016
Volume #62 (brown) Ayerst Laboratories, Dermoplast Aerosol

from the OTC Panel Submissions: 02 - Antimicrobial I,
Antimicrobial Data Submissions, Docket 74-20155 filed
9/12/1974.
FAERS MIDAZOLAM
NDA 050609 ANDA 062638
IMPORT RECS RE HENNINGSEN COLD STORAGE, OREGON ETC 01/01/2017
- 03/31/201
WILD FLAVORS INC, ERLANGER, KY CEI PHYSICIANS CEI PSC INC,
BLUE ASH, OH - 483 07/13/2015 - 12/06/2016
DESERET LABORATORIES, INC, SAINT GEORGE, UT GOOD BREAD INC,
DENVER, CO ETC - 483 10/23/2017 - 11/21/2017
SANOFI GENZYME, CAMBRIDGE, MA ETC - 483 08/01/2017 - 11/13/2017

SAINT LUKE'S MID AMERICA HEART INSTITUTE REGULATORY SUBMISSION
MDDT020
XIANGYANG COTO CHEMICAL CO LTD, CHINA - REGISTRATION RECS
12/17/2015 - 03/30/2016
K112314
K023562 K023086
COTT BEVERAGES USA, SIKESTON, MO ETC - INSPECTION RECS
08/04/2015 - 01/04/2018
NORTHWEST MEDICAL SPECIALTIES, WA - EIR 08/02/2017 -
03/15/2018
MITCHELL ZELLER, RICHARD TURMAN, JANELLE BARTH ETC - CV
ARROW RELIANCE, INC, TUKWILA, WA - 483 12/01/2017 - 03/15/2018

NDA 006035 ANDA 091577 PATIENT LABELING
PROVIGIL TESTING RECS
LISTING OF INSPECTIONS, INSPECTION CITATIONS 03/15/2017 -
03/15/2018
KOWA COMPANY LTD, JAPAN - 483 12/01/2016 - 12/31/2016
RIC LABS, CAVE CREEK, AZ - 483, EIR, RESPONSE 01/01/2015 -
01/05/2018
NECC VIDEO CLEAN ROOM
FCN 1574
CPT1700421, CPT1700422
PHILIPS MEDICAL SYSTEMS, CLEVELAND, OH - 483, EIR 07/01/2017 -
09/01/2017
HEALTHCARE INDUSTRIES MATERIALS, HEMLOCK, MI - EIR 05/22/2017 -
06/30/2017
FRUIT OF THE EARTH, GRAND PRAIRIE, TX - EIR 06/22/2016 -
03/15/2018
DR REDDY'S LABORATORIES, MEDAK, INDIA - 483 01/01/2018 -
03/20/2018
FOIA LOG ABBOTT, ABBOTT LABS, ABBOTT LABORATORIES 12/01/2017 -
02/28/2018
AMERICAN LABORATORIES, OMAHA, NE - 483, EIR, RESPONSE
01/01/2015 - 01/05/2018
DR REDDY'S , MEDAK, INDIA - 483 03/01/2018 - 03/19/2018
MEDICAL DEVICE LISTING REPORT 01/01/2013 - 03/13/2018
AUROBINDO PHARMA, BHIWADI, INDIA - 483 03/01/2018 - 03/13/2018

BLOOD BANK OF DELMARVA LIST OF APPROVED BIOLOGICAL PRODUCTS
01/01/1977 - 03/15/2018
ODYSSEY FOODS, LLC, SEATTLE, WA - EIR COLUMBIA NUTRITIONAL
LLC, VANCOUVER, WA - 483 UNIVERSITY OF OREGON, EUGENE, OR -
483 01/06/2017 - 10/17/2017
AMPLION CLINICAL COMMUNICATIONS, INC, NASHVILLE,TN BUNGE NORTH

AMERICAN, VIDALIA, LA ETC - 483, EIR 01/11/2012 - 09/07/2017
AMERICAN SUGAR REFINING, INC, YONKERS, NY ETC INSPECTION RECS
06/10/2015 - 01/18/2018
SMUCKER PET FOODS, EVANGER'S PET FOODS - RECALL RECS
01/01/2017 - PRESENT
AURONEXT, RAJASTHAN, INDIA AUROBINDO, HYDERABAD, INDIA - 483
03/01/2018 - 03/15/2018
DKT FDA95S0316
K140819
PAREXEL/FARMOVS, SOUTH AFRICA - EIR, 483
K093510
P160007, SUPPLEMENTS MEDTRONIC MINIMED GUARDIAN CONNECT SYSTEM

NDA 21-821 S 13 SBA
WEGMANS FSVP RECS 05/30/2017 - 03/16/2018
K142107
13927546 (Grastek) 13771076 (Bridion) 13927265 ETC
NUPLAZID AERS
BEND RESEARCH INC, BEND, OR - EIR 07/21/2017 - 03/16/2018
K170806
K171909
K101433
JANUVIA 13815335, 13834228, 13847872, ETC
TAYCA CORPORATION, JAPAN - 483 09/01/2016 - 09/30/2016
Korlym FAERS 01/01/2018 to the present
KEYTRUDA 13832950, 13840244, 13853224, ETC
CUSTOM UTRASONICS RECS 01/01/2010 - 02/22/2018
BK070067 BK160045 BK050055
Case reports for Zepatier
LAB RECS ENTRY 300-4053989-2
NDA 206927 COMPLETE RESPONSE LETTER ETC
GUANGZHOU TOPWORK CHEMICAL CO LTD, CHINA - REGISTRATION RECS
06/17/2015 - 06/17/2015
LUMIFY SBA
INDIVIDUAL RECS
483s issued by the New York DO Jan to Feb 2018
483s issued by the New Orleans DO Jan to Feb 2018
483s issued by the New Jersey DO Jan to Feb 2018
API PLANT 1, MEDAK, INDIA - 483 02/01/2018 - 03/31/2018

MEAN AND MEDIUM FULL AND TENTATIVE APPROVAL TIMES UNDER GDUFA
ETC
INDIVIDUAL RECS, AERS 01/01/2015 - 03/16/2018
CASE REPORTS VIAGRA, CIALIS, LEVITRA
DERMARITE INDUSTRIES, LCC, NORTH BERGEN, NJ - EIR, 483
01/01/2013 - 01/03/2018
BIOTIN CASE REPORT, MEDWATCH
SCHOTT NORTH AMERICA, INC PHARMACEUTICAL PACKAGING OF LEBANON,

PA - 483, 482, RECALLS ETC 10/23/2013 - 03/16/2018
483s issued by the Baltimore DO in Jan and Feb 2018
483s issued by the CDER International Operations Office Jan to
Feb 2018
483s issued by the New England DO Jan to Feb 2018
483s issued by the Minneapolis DO Jan to Feb 2018
483s issued by Los Angeles DO Jan to Feb 2018
K161624
NDA 206140
COMMUNICATIONS WITH OCI
NDA 013601
NDA 208418
483s issued by the Kansas City DO Jan to Feb 2018
483s issued by the Florida DO Jan to Feb 2018
483s issued by the Detroit DO Jan to Feb 2018
483s issued by the Denver DO Jan to Feb 2018
483s issued by the Cincinnati DO Jan to Feb 2018
483s issued by the Chicago DO Jan to Feb 2018
483s issued by the Dallas DO Jan to Feb 2018
483s issued by the CDRH International Operations Office Jan
to Feb 2018
483s issued by the CDER International Operations Office
(complex queue) Jan to Feb 2018
2017 RJ Reynolds/American Snuff Product Listings (June and
December) and any recent HPHC Reports/Ingredient Listings
483s issued by Atlanta DO in Jan and Feb 2018
483s issued by the CBER International Operations DO Jan to Feb
2018
483s issued by the San Juan DO Jan to Feb 2018
483s issued by the Seattle DO Jan to Feb 2018
483s issued by the San Francisco DO Jan to Feb 2018
483s issued by the Philadelphia DO Jan to Feb 2018
LASER PHARMACEUTICALS LLC, GREENVILLE, SC - ANDA, IND,
INSPECTION RECS ETC 08/01/2011 - 03/16/2018
COMPLIANCE CHECK INSPECTIONS TOBACCO PRODUCTS RETAILERS NJ
08/08/2016 - 08/07/2017
COMPLIANCE CHECK INSPECTIONS INVOLVING SALE TO A MINOR IN NJ
08/08/2016 - 08/07/2017
INDIVIDUAL RECS
RECS RE COMMUNICATIONS WITH OUTSIDE PARTIES FOR FINAL RULE ON
SERVING SIZES RACC TO CALCULATE THE SERVING SIZE FOR SOUP
01/01/2012 - 11/01/2016
"The Food and Drug Administration's Food-Recall Process Did Not
Always Ensure the Safety of the Nation's Food Supply" - RECS RE
ILLNESS, DEATH
NDA 208582
100036512 100036702 100037903 ETC
AUROBINDO PHARMA UNIT XII, HYDERABAD, INDIA - 483 03/05/2018 -
03/16/2018
K153239
DARVACET (PROPOXYPHENE-N100)
CURRENT DEVICE LISTING APPROVED MEDICAL IMAGING DEVICES
03/16/2018 - 03/16/2018
NDA 016363
SUVEN LIFE SCIENCE, TELANGANA, INDIA - 483 01/01/2018 -
03/18/2018
ANDA 205327
CORR BETWEEN FDA AND JANSSEN PHARMACEUTICALS RE PRIOR APPROVAL
SUPPLEMENTAL NEW DRUG APPLICATION
De Novo Classification Request for ImPACT and ImPACT Pediatric
INDIVIDUAL RECS
LIBRAX NDA 12-750 - LBLG,SUPPLELMENTS
SCHMUCK MARKETS INC - IMPORTER LIST
EXECUTION OF CLNCL TRIALS SENT TO THE FDA OFFICE OF SCIENTIFIC
INVESTIGATIONS 1/1/13 TO PRESENT
OCALIVA - AERS 8/1/17 TO 3/20/18
D-LIMONENE - GRAS
BAYER OY, TURKU, FINLAND MEDILINK HOSPITAL AND RESEARCH
CENTER, AHMEDABAD, INDIA TEVA PHARMACEUTICAL INDUSTRIES LTD,
KFAR SABA, ISRAEL - 483S
EFFEXOR - AERS
WELLBUTRIN - AERS
SYNTHROID - AERS
K170551
483 REPORTS STEM CELL CLINICS 01/01/2015 - 01/01/2018
2018-954 2018-993 2018-1003 ETC
2018-575 2018-578 2018-689 ETC
EVANGER'S DOG AND CAT FOOD COMPANY, INC, WHEELING, IL
NURTIPACK LLC, MARKHAM, IL - EIR 01/01/2017 - 03/19/2018
K163253
EYLEA AERS
LUMIFY SBA
K171186
GREEN TEA FAT BURNER - AERS, COMMUNICATIONS, INSPECTION RECS
IRVIN NATURALS 01/01/2018 - 03/19/2018
K163328
SUN HALOL INDIA - 483, INSPECTION RECS 12/01/2017 - 01/08/2018

FAP 4B3801
K170150
FAERS 7400426, 7400981, 7400982, ETC

K170150
NDA 208845
NDA 202379, SUPPL-24
2017-4881
MIMEDX GROUP INC, MIMEDX TISSUE SERVICES, MARRIETTA, GA - 483
RESPONSE, CORR, ETC 01/01/2016 - 03/19/2018
Product Standard for Nicotine Level of Combusted Cigarettes
(RIN 0910-AH86) ETC
KING & PRINCE SEAFOOD, BRUNSWICK, GA - EIR 02/12/2018 -
02/16/2018
K162919
DRUG APPROVAL DATA
AURONEXT MANUFACTURING, INDIA - 483 02/01/2018 - 03/20/2018
ANDA 075079
SBOA NDA 011245
NDA 017577
FDA LETTERS RE CINNARIZINE
K161068
DEN 140025
CIPLA, GOA, INDIA - 483 12/01/2017 - 02/15/2018
WEXLER SURGIVCAL, HOUSTON, TX - EIR 01/01/2016 - 03/31/2017
2017-8561 2017-8412 2017-8389 2017-8388 2017-8256 2017-8199

CAERS 01/01/2017 - 03/31/2018
JINAD 002-681 INAD
CONSUMER COMPLAINTS RODAN & FIELDS, LLC ETC
MERCK SHARPE & DOHME CORP, MIAMI LAKES, FL - EIR 01/01/2015 -
12/31/2015
BREAST HEALTH CCENTER, GREENBRAE, CA - INSPECTION RECS,
COMPLAINTS 01/01/2017 - 12/31/2017
NDA 011210
DEN170022
CORR MCID RE NDA 20-272/S-036/041, NDA 20-588/S-024/028/029,
NDA 21-444/S-008/015
CORR LOG REP KEITH ROTHFUS 01/01/2013 - 03/20/2018
FDA Staff Manual Guide 4850.7
K151683
CPT1700568
NDA 018310 LABELING
INTERVIEW RECS
K170195
NDA 017641
K083113
K160974
Ocaliva FAERS
EON-347521
CIVITAS/ACORDA, CHELSEA, MA - INSPECTION RECS 10/01/2014 -
01/05/2018
SAGER CREEK FOODS, INC, TURKEY, NC DONALD C TOWNSEND, AUGUSTA,
GA THE PROCTER & GAMBLE MANUFACTURING COMPANY, GREENSBORO, NC
ETC 483 02/02/2015 - 11/17/2017
AMGEN MAUFACTURING LIMITED, JUNCOS, PR, ETC 483 02/03/2015 -
12/29/2017
BIMBO BAKERIES USA, INC, HUNTINGTON, WV AMERICAN SUGAR
REFINING, INC, BALTIMORE, MD RUWANTI GUNAWARDANE ETC, FULTON,
MD - 483 03/16/2016 - 03/22/2017
CORR BETWEEN FDA, EARTH ANIMAL/EARTH ANIMAL VENTURES RE NO HIDE
CHEW ETC 01/01/2017 - 03/20/2018
DAIRY FARMERS OF AMERICAN, INC, HUGHSON, CA, ETC - 483
03/27/2009 - 04/11/2017
"Regulation of Flavors in Tobacco Products (RIN 0910-AH60), ETC

DOMINGUEZ FOODS OF WASHINGTON, INC, ZILLAH, WA ETC - 483
09/13/2016 - 10/26/2017
MITCH ZELLER, RICHARD TURMAN EMAILS 01/23/2017 - 03/20/2018

RECS RE AERS OCALIVA, SAFETY ANNOUNCEMENT, DOSING ETC
03/01/2012 - 03/20/2018
AKORN PHARMACEUTICALS, COPIAGUE, NY - 483 06/01/2017 -
03/21/2018
Disulfiram (Antabuse) NDA and drug approval package
ADDERAL IR, ADDERAL XR, VYVANSE - TRIAL RECS
QUARTERLY PROJECT TRIDENT OR QUALITY EXCELLENCE PLAN UPDATED
ZIMMER BIOMET HOLDINGS INC TO DETROIT DISTRICT 09/01/2013 -
03/21/2018
ABILIFY - SENSORS EMBEDDED IN THE PILLS
OFFICE OF PUBLIC AFFAIRS - MATERIALS RELATED TO ALL AGENCY
EMPLOYEES
BIOMET INC - FULL HEMISPHERE RING-LOC K920640
NURSE ASSIST INC - SALINE FLUSH IV SYRINGE RECALL RECS
CLOPIDOGREL TABS - RECALL RECS
FOIA REQUESTS
MCKESSON CORP, PURDUE PHARMA LP, CARDINAL HEALTH INC, ETC -
PHONE LOGS, EMAILS, TALKING POINTS, ETC
REP STEVE CHABOT - CONGRESSIONAL CORR 1/1/11 TO 3/16/18
AUROBINDO PHARMA's UNIT 4 EIR 05/01/2017 - 01/08/2018
LAMICTAL - AERS
EAGLE PHARMACEUTICALS INC V THE UNITED STATES DEPARTMENT OF
HEALTH AND HUMAND SERVICE ET AL - ADMINISTRATIVE RECS
SWORN STATEMENTS OF FORMER EMPLOYEES OF PHILIP MORRIS USA INC

AIR SOURCE INDUSTRIES - NITROUS OXIDE, ROCKET NITROUS
MANUFACTURING, DESIGN, MARKETING, ETC
AIRGAS INC - NITROUS OXIDE, NITROUS PLUS MARKETING , CMPLNTS,
SAFETY DATA, ETC
AIR SOURCE INDUSTRIES - CMPLNT 13-0654M
IMPAX LABORATORIES INC - FENOFIBRATE TABS ANDA 76-509 SBA
ADB INTERESTS LLC, PEARLAND, TX - EIRS, CORR, NOTES, ETC
DMF 25819
ADITYA LABS INC, SOMERSET, NJ - ANDA, IND, ETC 08/01/2011 -
03/14/2018
K113501
TEVA WOMEN'S HEALTH, CINCINNATI, OH - EIR 11/10/16
DILIP SOLANKI, BOONTON, NJ - ANDA, IND, EIR ETC 08/01/2011 -
03/14/2018
INVADERM CORPORATION, SOMERSET, NJ - ANDA, IND, EIR ETC
08/01/2011 - 03/14/2018
Study of mutagenic effects of sodium acid pyrophosphate
Vanilla SilQ, VANILLA SILQ MD, VANILLA SILQ HD AERS
MONAT GLOBAL CORP - COMPLAINT RECS 01/01/2010 - 03/20/2018
RECS RE CUSTOM ULTRASONICS
ESTANCIA ESTATES WINERY, SOLEDAD, CA, CONSTELLATION BRANDS,
INC, GONZALES, CA - FSMA REPORT 02/06/2018 - 03/09/2018
COMPLAINT RECS CC 152108
EPIPEN, EPIPEN JR PERFORMANCE DATA 01/01/1987 - 03/21/2018
NDA 016693
GRN 669
NDA 016682
K9900067 K970577
Notices of intent regarding electronic advertising for
Reynolds, from 2009 - Present
Copy of the disclosable portions of all notices of intent
regarding electronic advertising for ITG, from 01/01/2009 -
present
regarding electronic advertising for American Snuff Company,
from 01/01/2009 - present
regarding electronic advertising for Stoker's, from 01/01/2009
- present
DEVICE COMPANY WARNING LETTERS HCT/P 06/01/2017 - 03/21/2018

NDA 019632
CIPLA LIMITED, GOA, INDIA - 483 01/01/2018 - 01/31/2018
NDA 017378
LIST OF CLASSIFIED DRUGS RECALLED BY FDA 01/01/2012 -
01/04/2018
Nuplazid FAERS 01/01/2018 to present
List of all the Human drug products approved by the FDA between
Jan 1998 to March 14, 2018 that have therapeutic equivalents
greater than 0 and less than 3
ANDA 207014 SBA
K173426 FIRST PARTY
NDA 010379
DAEWOONG PHARMACEUTICAL CO LTD, KOREA - ASSAY METHODS
11/01/2016 - 03/21/2018
NADA 140-338
K173447 FIRST PARTY
Full Color Additive Petition for Fruit Juice - Foods Generally
(Section 73.250) Full Color Additive Petition for Grape Color
Extract (Section 73.169) Full Color Additive Petition for Fruit
Juice - Dried Color Additive (CAP# 5C0245)
NDA 021852/S-018 APPROVAL LETTER
XELLIA PHARMACEUTICALS, HUNGARY CHANGZHOU SUNLIGHT
PHARMACEUTICAL CO LTD, CHINA NORTH CHINA PHARMACEUTICAL, CHINA
- EIR, 483 07/01/2011 - 09/30/2015
NDA 208418 Suppl-1

RESPONSE TO SENATORS 2/7/18 LETTER RE IQOS
MIRALAX AERS
FAERS 7367658 8707511 8725510 ETC
MACRILEN CORR, MEETING MINUTES 01/01/2009 - 11/07/2014
CDER CORR RE GENERIC APPLICATIONS RAISING CONCERNS RE
DIFFICULTIES OF OBTAINING SAMPLES
NDA 021196 S019
RECS RE REFUSAL TO FILE decision CELGENE NDA OZANIMOD
K912938 K010728
ORPHAN DESIGNATION APPLICATION BACILLUS THURINGIENSIS CRYSTAL
PROTEIN
JIANGXI DADI PHARMACEUTICAL LIMITED COMPANY, CHINA -
REGISTRATION RECS 07/24/2015 - 07/24/2015
ZIMMER BIOMET HOLDINGS INC - MINUTES, NOTES, MEMORANDA ETC
MEETING REFERENCE IN EIR 05/01/2013 - 04/29/2014
K093934
K911588
A copy of the draft regulatory action: "Regulation of Premium
Cigars (RIN 0910-AH88), ETC
K132105
K091869
K131287 K170874
DR JAMES FELDMAN, KATY CARDIOLOGY, ETC, KATY, TX - INSPECTION
RECS 10/01/2016 - 10/26/2016
K131861 REVIEWER NOTES
K133942 Reviewer's notes
UBE INDUSTRIES, JAPAN - 483 09/01/2017 - 12/31/2017
K142937 REVIEWER'S NOTES
JFC INTERNATIONAL, FREMONT, CA - RECS RE RECALL ITEM
DISPOSITION
RECS RE 95-MIF-703-084
K151363
LIST OF DEVICE INSPECTIONS 01/01/2008 - 12/31/2017
SIMPSON, ERICKA, MD, HOUSTON, TX - EIR, 483, CORR 10/24/2017 -
11/01/2017
RAO, MEMANTH, MD, CHARLOTTE, NC - EIR, 483, CORR 11/06/2017 -
11/14/2017
TESTING PROTOCOLS TO VERIFY ABILITY OF SHARPS TERMINATOR TO
INCINERATE NEEDLES
SCHNADOWER, DAVID, ST LOUIS, MO - EIR, 483, CORR 06/15/2017 -
06/22/2017
LIGHT AGE, INC, SOMERSET, NJ - EIR, 483, CORR 10/21/2017 -
11/17/2017
COENZYME A, INC, LYNNWOOD, WA - EIR, 483, CORR 09/13/2017 -
09/26/2017
BIOMODELING, INC, BEAVERTON, OR - EIR, 483, CORR 08/21/2017 -
09/11/2017
CHLORINE DIOXIDE EFFECTIVE FOOD CONTACT SUBSTANCE NOTIFICATIONS
01/01/2010 - 03/01/2015
VILEX IN TENNESSEE, INC, MCMINNVILLE, TN - EIR, 483, CORR
08/16/2017 - 08/25/2017
FDA FOIA LOG PRILOSEC, NEXIUM 01/16/2018 - 03/27/2018
AMERICAN CRYOSTEM CORPORATION, EATONTOWN, NJ - EIR, 483, CORR
07/17/2017 - 07/26/2017
TRUXTON, INC, BELLMAWR, NJ - EIR, 483, CORR 04/17/2017 -
06/01/2017
Any and all approval letters relating to the Bronco cigarette

brand as grandfathered, predicate or substantial equivalent
ACADEMIC MEDICAL RESEARCH INSTITUTE, LOS ANGELES, CA - 483
02/01/2016 - 02/28/2018
LASER DENTAL INNOVATIONS, SAN JOSE, CA - EIR, 483, CORR
12/04/2017 - 12/14/2017
DEN160012
DOMPERIDONE BRIEFING PACKAGE, MEETING MINUTES 10/25/1988 -
06/25/1989
CAS MEDICAL SYSTEMS INC - AMI PLUS, INFANT CENTRAL APNEA/HEART
RATE MONITOR MDR
GLUCOSE TEST STRIPS - CORR, NOTES, CONVERSATIONS, ETC
SALMONELLA IN RAW PET FOOD - RPTS, EMAILS, COMM, ETC
BOVINE SPONGIFORM ENCEPHALOPATHY (BSE) MAD COW , AL, CADISEASE
- RPTS 2012, 2017
ELECTRONIC COMMUNICATIONS BTWN FDA, GATEWAY PUNDIT REGARDING
BREITBART, INFOWARS, ETC 1/20/2017 TO PRESENT
YOGURT PRODUCTS - LBLG, TEST RESULTS, NUTRITIONAL RECS
GABAPENTIN 900 MG, BENADRYL 150 MG, CYMBALTA (DULOXETINE) -
AERS
LNO #205, application package and decision memorandum for post-
consumer recycled high-density polyethylene suitable for food
contact
NAPA VALLEY VINTNERS, CLIFORNIA ASSOCIATION OF WINEGRAPE
GROWERS, HOP GROWERS OF AMERICA, ETC - PRODUCE SAFETY RULE
CORR, MEMOS, MEETINGS
COMPLAINTS, REPORTS RE KELOID HYPERTROPHIC SCARRING REJUVI
TATTOO REMOVAL 01/01/2014 - 01/01/2017
APPROVALS, DENIALS, COMMUNICATIONS BETWEEN FDA AND MIMEDX RE
APPROVAL STATUS OF AMNIOFIX & ORTHOFLO INJECTABLE 01/01/2013 -
03/23/2018
MEDTOX LABORATORIES, INC, ST. PAUL, MN - EIR ETC 06/21/2005 -
04/04/2014
AURONEXT, INDIA - 483 02/26/2018 - 03/23/2018
Summary for HPM6000U (K162010)
Biological Product Deviation (specifically HCT/P Deviation
Reports) for Mimedx, Mimedx Tissue Services and Surgical
Biologics
K162608
CAP 1C0273
K160176
FDA-2011-P-0576 FDA-2015-P-4770
NADA 140-951
OCI RECS 2008-TFM-723-0256-P 09-TFM-709-0257 09-TFM-709-0257

MONARCH SYSTEM AURIS CORPORATION 510K
FDA MARKETING STAFF
NORTHWESTERN CENTER FOR CLINICAL RESEARCH, CHICAGO, IL - 483,
RESPONSE ATTACHMENTS 02/01/2007 - 12/31/2008
ALKEM LABS, DAMAN, INDIA - 483 03/20/2018 - 03/30/2018
ALEMBIC, PANELEV, INDIA - 483 03/12/2018 - 03/21/2018
ALEMBIC, PANELEV, INDIA - 483 03/01/2018 - 03/21/2018
ALEMBIC PHARMACEUTICALS, PANELEV, INDIA - 483 03/12/2018 -
03/20/2018
03/20/2018
K082898
LEVOLEUCOVORIN FAERS
21ST CENTURY CURES ACT SECTION 3001-3004 RECS PATIENT
EXPERIENCE BLA 01/01/2013 - 03/22/2018
03/31/2018
AXIS CLINICALS LIMITED MIYAPUR, INDIA - EIR 03/01/2016 -
08/31/2016
RECS RE BIOSIMILAR ADVISORY COMMITTEE INTERCHANGEABILITY,
INTERCHANGEABLE 01/01/2017 - 03/23/2018
03/20/2018
LUMIS GLOBAL PHARMACEUTICALS CO LTD, CHINA - 483 09/26/2016 -
09/28/2016
INDOCO REMEDIES LIMITED, GOA, INDIA - 483 08/31/2016 -
09/04/2016
DAEWONG, SOUTH KOREA - 483 11/02/2017 - 03/23/2018
CHANGZHOU JINTAN QIANYAO PHARMACEUTICALS RAW MATERIAL FACCTORY,
CHINA - 483 02/13/2017 - 02/17/2017
NDA OCALIVA RECS
PRO-AIR RESPICLICK FAERS
FAERS RECS 01/01/2000 - 12/31/2004
NDA 020126
FLUOROURACIL LABEL WARNINGS ETC 01/01/2005 - 01/01/2015
ONDANSETRON MEDWATCH REPORT 01/15/2018 - 01/19/2018
LIST OF INTERSTATE SHELLFISH SHIPPERS 12/31/2017 - 12/31/2018

ANDA 072741
SICHUAN FRIENDLY PHARMACEUTICAL CO LTD, CHINA - EIR, 483, CORR
10/01/2017 - 03/26/2018
PROMISEMED HANGZHOU MEDITECH COT LTD, CHINA - 483 01/01/2016 -
03/26/2018
RECS RE MEETING BSUFA II 2/27/18
DMF 017995
AUSTEDO FAERS
RECS RE CLINICAL TRIAL 1VIT05006
CLINICAL TRIAL RECS 1VIT06011
ALKEM, DAMAN, INDIA - 483 MARCH 2018
NDA 018932
NDA 016793
CLINICAL TRIAL RECS 1VIT04002/003
NORWICH CLINICAL SERVICES PVT LTD, INDIA - EIR 03/01/2015 -
03/27/2018
CLINICAL TRIAL RECS 1VIT03001
CLINICAL TRIAL RECS RE 1VIT04004
CLINICAL TRIAL RECS RE 1VIT05005
ZECUITY FAERS
PHILIPPE LABERGE, MD, QUEBEC CITY, CANADA ETC - 483 01/02/2012
- 03/27/2018
FDA, CFSAN. Real Progress in Food Code Adoptions. May 2002
quarterly update June 2006.
CANADIAN MEDICAL DEVICE 483 12/01/2008 - 03/27/2018
2017-10016
2018-1399
LUMIFY APPROVAL RECS
ACUMED, LLC, HILLSBORO, OR - 483, EIR, CORR 5/11/17
RECS RE SALMONELLA TYPHIMURIUM OUTBREAK CHICKEN SALAD
01/01/2018 - 03/27/2018
GLATOPA FAERS
OPTERNATIVE INC COMMUNICATIONS TO FDA 01/01/2015 - 03/27/2018

ALLERGAN SALES, WACO, TX - 483, EIR, CORR 10/8/15
AIRGAS USA, SYRACUSE, NY - 483, EIR, CORR 1/18/18
ALKEM LABORATORIES, DAMAN, INDIA - 483 03/01/2018 - 03/27/2018

ANDOVER HEALTHCARE INC - COMMUNICATIONS WITH FDA 01/01/2011 -
01/01/2016
DIAMOND WIPES INTERNATIONAL INC, CHINO, CO - 483, EIR, CORR
05/08/2017 - 05/17/2017
BECTON DICKINSON AND COMPANY, FRANKLIN LAKES, NJ - 483, EIR,
CORR 05/15/2017 - 06/06/2017
RECS RE COMMUNICATIONS, MEETINGS, ETC RE 7/25/17 MEETING AT

CFSAN AND NATIONAL MILK PRODUCERS FEDERATION RE IMITATION DAIRY
K173760
K130288
AZACITIDINE FAERS
K142468
K162503
KERALINK WEST LOS ANGELES, LOS ANGELES, CA - EIR 01/01/2016 -
03/27/2018
ABBOTT POINT OF CARE CANADA LIMITED NEPEAN ETC 483 11/03/2008 -
03/27/2018
ALLERMED LABORATORIERS, SAN DIEGO, CA - EIR, 483, CORR 6/14/17
BATTLE CREEK EQUIPMENT, FREMONT, IN - EIR, 483, CORR 5/31/17

BIO-THESIOMETER USA, CLEVELAND, OH - EIR, 483, CORR 1/19/18
BPL PLASMA, SAN MARMOS, TX - EIR, 483, CORR 1/17/17
3M CO, VALLEY, NE - EIR, 483, CORR 6/16/16
IMPAX LABORATORIES, HAYWARD, CA- EIR, 483, CORR 8/23/17
CINQAIR FAERS
CATALENT PHARMA, MORRISVILLE, NC - EIR, 483, CORR 5/19/17
SALEM GALAL, MD, RIVERSIDE, CA - EIR, 483, CORR 8/25/17
HOBBS MEDICAL, STAFFORD SPRINGS, CT - EIR, 483, CORR 6/23/17

DAILY CLOSED LOG 2/19-23/18
CLOSED DAILY LOG 2/26/18-3/2/18
CLOSED LOG 2/26-3/2/18
DAILY LOG 2/26/18-3/2/18
ARMONAIR RESPICLICK FAERS
DAILY LOG 2/26/18-3/2/18
DAILY LOG 2/26/18-3/2/18
DAILY LOG 2/26/18-3/2/18
CLOSED LOG 2/26/18-3/2/18
DAILY LOG 2/26/18-3/2/18
AIRDUOTM RESPICLICK FAERS
DAILY LOG 2/26/18-3/2/18
CLOSED LOG 2/26/18-3/2/18
DR REDDY'S LABORATORIES LTD, ANDHRA PRADESH, INDIA - 483 5/18

TRACKED SAFETY ISSUES PROTEIN PUMP INHIBITORS 01/01/2016 -
03/27/2018
MEMO BY JOYCE KORVICK MD, MPH RE PROTEIN PUMP INHIBITORS AND
CHRONIC KIDNEY DISEASE, ACUTE KIDNEY INJURY 01/01/2016 -
03/27/2018
2012-839, 2013-6820, 2015-1398, ETC
NUMBER OF HPE SERVERS AND STOAGE LOCATED AT CENTERS FOR FDA
SERIAL NUMBERS AND PRODUCT NUMBERS OF HPE SERVERS, ETC
INDIVIDUAL RECS
OLYMPUS - DUODENOSCOPES RPTS
FDA PURCHASE CARD HOLDERS LIST 01/04/2017 - 01/04/2018
ALKERMES PLC, VIVITROL - RECS
WHAT TESTS ARE USED BY FDA FOR ADULTERATION, TESTS FOR SAFETY
OR QUALITY,ETC
ARROW RELIANCE INC (DBA DARWIN'S NATURAL PET PRODUCTS) - FDA
ALERT 2/13/18
TECHNICAL LEAD REPORTS, DECISION SUMMARIES EXEMPTION FROM
SUBSTANTIAL EQUIVALENCE FINAL ORDERS
A ND G PHARMACEUTICAL INC, BIOQUAL INC, CL LABORATORY, ETC -
CORR 8/31/17 TO 1/31/18
K033840 K003301 K973050 ETC
NDA 203314/S-008
2017 Federal Employee Viewpoint Survey, 4th Level Subagency
Report, Midwest Area Office. 2017 FDA/OCI, Chicago Field
Office, Office Inspection Report.
OCI-Chicago Field Office Inspection Report which occurred March
of 2017, including all reports, attachments, results of
employee interviews by OIA
Technical Lead Reports and decision summaries for the twenty-
three (23) Exemption from Substantial Equivalence Final Orders
issued in September 2017
K080872
HUY FONG FOODS INC, IRWINDALE, CA - INSPECTION RECS 01/01/2017
- 01/04/2018
5/16/2017 Social Science Memo referenced in the Scientific
Review of EX0000175 (Exemption from SE Final Action in August
2017)
INDIVIDUAL RECS
ALKEM LABS, DAMAN, INDIA - 483 03/19/2018 - 03/27/2018
K162309
MOHAMED A. EL-SHAHAWY, MD, ACADEMIC MEDICAL INSTITUTE, LOS
ANGELES, CA - EIR 02/03/2015 - 03/19/2015
Drug Master File #16173
Technical Lead Reports and decision summaries for the one (1)
Exemption from Substantial Equivalence Final Orders issued in
January 2018
Information regarding amantadine HCl orphan drug designation

DS-2019 documents
COVIS PHARMA BV - ZANAFLEX NDA 20-397, NDA 21-447
K960091
INDIVIDUAL RECS
FSVP IMPORTER RECS
NORBROOK LABORATORIES, NEWRY, NORTHERN IRELAND SPARKHAWK
LABORATORIES, LENEXA, KS - 483 01/01/2015 - 03/26/2018
SHANGHAI SHYNDEC PHARMACEUTICAL CO, LTD, CHINA - 483 12/01/2017
- 12/31/2017
K932385 K935665 ACCEPTANCE LETTERS
ALKEM, DAMAN, INDIA - 483 03/18/2018 - 03/28/2018
ZIMMER BIOMET PROGRESS UPDATE ETC 10/17/2017 - 03/28/2018
K163283
TIANJIN MINXIANG BIOMEDICAL TECHNOLOGY CO LTD REGISTRATION RECS
01/22/2015 - 08/11/2015
USPLABS LLC - OXYELITE PRO, JACK3D WITH DMAA WARNING LTR
4/24/12, REYNALDO RODRIQUEZ JR LTR 10/8.13, ETC
86P-0131 CP and Corresponding FDA response
K171646

MEDICAL USE OF MARIJUANA - RECS
XTAMPZA ER NDA 208-090 SBA
TINEA VERSICOLOR - RECS
ZIMMER BIOMET, WARSAW, IN - 483, WARNING LTRS, UPDATES, ETC
BETAHISTINE RECS RE WITHDRAWAL OF APPROVAL
ALKEM, DAMAN, INDIA - 483 03/11/2018 - 03/28/2018
Copy of the 7/14/2017 Toxicology Memo referenced in the
Scientific Review of EX0000174
PROMISEMED HANGZHOU MEDITECH CO - EIR 02/02/2015 - 02/06/2015

CISPHARMA, CRANBURY, NJ - EIR 01/01/2011 - 12/31/2013
KATENA PRODUCTS, MIMEDX, AMBIODISC RECSC 01/01/1997 -
03/28/2018
ONCOTEC, GERMANY - EIR 10/16/2017 - 03/28/2018
K863815
NDA 8173
BIOMAT USA, ANDERSON, IN SHIRE HUMAN GENETIC THERAPIES INC,
CAMBRIDGE, MDA HOSPIRA PFIZER COMPANY, ROCKY MOUNT, NC ETC -
483
MAVYRET AERS
K101342
K860467
ANDA 60642 NDA 50012
DRUG, BIOLOGICS INSPECTIONS IN INDIA, CHINA01/01/2014 -
03/29/2018
NDA 60180
FOIA REQUEST LOG 10/01/2017 - 03/29/2018
INDOCO REMEDIES LIMITED, VERNA, INDIA - 483 08/31/2016 -
09/04/2016
TRANSMEDICS, ANDOVER, MA - EIR, 483, CORR 4/26/17
SOVEREIGN PHARMACEUTICALS, FORT WORTH, TX - EIR, CORR, 4383
1/12/18
BERNARD A MICHLIN, MD, SAN DIEGO, CA - EIR, 483, CORR 9/1/17

PHARMATECH, DAVIE, FL - EIR, 483, CORR 5/2/17
HERON THERAPEUTICS, LIFECORE BIOMEDICAL, CHASKA, MN - AERS RE
SUSTOL, 483, WARNING LETTERS 03/29/2015 - 03/29/2018
UCSF MEDICAL CENTER CLINICAL LABORATORIES BLOOD CENTER, SAN
FRANCISCO, CA - EIR, 483, CORR 1/19/18
HERON THERAPEUTICS, ALCAMI CORPORATION, NORTH CHARLESTON, SC -

AERS RE CINVANTI, 483, WARNING LETTER: 03/29/2015 - 03/29/2018
SYNTHO PHARMACEUTICALS, INC, FARMINGDALE, NY - EIR, 483, CORR
3/9/17
JOHNSON & JOHNSON CONSUMER, LITIZ, PA - EIR, 483, CORR 9/21/15

WYETH PHARMACEUTICAL DIVISION OF WYETH HOLDINGS, SANFORD, NC -
EIR, 483, CORR 7/23/14
CLOVER CUSTOM BLENDING, TAMPA, FL - EIR, 483, CORR 05/15/2017 -
05/17/2017
FAERS 3023863, 3390564, 3494539, ETC
NDA 050746 ANDA 201587, NDA 050703 ETC SBA
PHARMACTIVE, TURKEY - EIR, 483, RECALLS ETC 03/03/2012 -
03/29/2018
RADIOLOGICA, ST LOUIS, MO - EIR, 483, CORR 1/19/18
NDA 20553
2018-1727
2018-2011
BK160027 BK090007
INDIVIDUAL RECS
K911144
ECT Device Medcraft B24 file
ECT manufacturer Leadenhall Sterling Inc
ECT manufacturer Lektra Service Corp
K760462, K770276, K781318
SWAG, 221 ENTERPRISES LLC ENFORCEMENT RECS, COMPLAINTS
06/01/2013 - 11/01/2014
K884888 K884889 K904879 ETC
ECT manufacturer Leaven Enterprise
ECT manufacturer General Medical Industries, Inc.
CTP REVIEWING GUIDES, CHECKLIST, PROCEDURES FOR REVIEW AND
EVALUATION OF MODIFIED RISK TOBACCO PRODUCT APPLICATIONS
ECT Manufacturer Custom Systems Associates, Inc.
ECT manufacturer General Medical Industries Inc.
K171102
NDC CODES
FCN 1030
BLA 125522
FSVP LIST OF IMPORTERS
K102973
Supporting Memoranda Cited by the Toxicology reviewer(s) in the

3rd Cycle of Review for seven SE Reports submitted by PM USA
MONTERIS MEDICAL, PLYMOUTH, MN - HHE, HHA, ETC RECALLS
01/01/2014 - 03/30/2018
Supplemental approval information for Xtampza ER, N208090/S4,
approved 11/6/2017
Gardasil, Gardasil 9, and Cervarix VAERS
JC WORLD BELL WHOLESALE INC, HACKENSACK, NJ SAVINGS
DISTRIBUTORS LLC, ISLANDIA, NY SESSIONS SPECIALTY COMPANY,
LEWISVILLE, NC ETC - 483 03/31/2013 - 03/30/2018
FDA 2512 AVEENO STRESS RELIEF MOISTURIZING LOTION 2. AVEENO

STRESS RELIEF BODY WASH 3. AVEENO POSITIVELY NOURISHING CALMING
BODY LOTION 4. AVEENO POSITIVELY NOURISHING CALMING BODY WASH
PREMARIN VAGINAL CREAM ORIGINAL LABEL
AMALIYA, DAMAN, INDIA - 483 03/19/2018 - 03/27/2018
TAYCA CORPORATION, JAPAN - 483 09/01/2016 - 09/30/2016
New Dietary Ingredient notification 947 and its appendices
FOUR COMMENTS RE FDA DELAY OF COMPLIANCE DATE FOR FINAL RULE
REQUIRING DISCLOSURE OF CERTAIN NUTRITION INFORMATION FOR
STANDARD MENU ITEMS 02/01/2015 - 06/30/2015
XTAMPZA ER NDA 08-090 SBA FOR EFFICACY SUPPLEMENT 4
AGREEMENT RECS REGARDING PLASMA PRODUCTS
WHPM INC, IRWINDALE, CA - EIR 6/1/10 - 7/1/16
GLAXO SMITH KLINE - COMPAZINE NDA 10-571, 10-742, 11-000 ETC
LBLG
K061718
WOLTERS KLUWER CORP - CARBAMAZEPINE LBLG, APRVL
INDIVIDUAL RECS
LIST OF INSPECTIONS MARCH 2018
RECS RE CONCLUSION THAT KRATOM CONTAINS OPIOIDS 01/01/2014 -
03/23/2018
EMAIL TO, FROM RPHILLIPS@AHI.ORG 01/01/2016 - 03/29/2018
EMAIL TO, FROM BETH.ELLIOTT@ZOETIS.COM
ABREGMAN@BOCKORNYGROUP.COM 01/01/2016 - 03/30/2018
LIST OF INSPECTIONS 04/01/2017 - PRESENT
LETTER FROM KAREN MIDTHUN AND JANET WOODCOCK TO RONALD T
PIERVINCENZI, USP 03/12/2014 - 03/14/2014
NORTHWESTERN UNIVERSITY INSTITUTIONAL REVIEW BOARD - EIR
EXHIBITS 11, 12, 14, 15 8/8/08
AKORN PHARMACEUTICALS INC, DECATUR, IL SOMERSET, NJ ETC 483
05/01/2017 - 04/02/2018
ALKEM LABS DAMAN, INDIA - 483 03/01/2018 - 04/01/2018
"Revised Recommendations for the Prevention of Human
Immunodeficiency Virus (HIV) Transmission by Blood and Blood
Products" dated April 23, 1992.
DR REDDY UNIT 1, INDIA - 483 02/01/2018 - 04/01/2018
ANDA 040885
UCB PHARMA SA CHAUSSEE DE TUBIZE, BELGIUM - 483, EIR, CORR
09/01/2015 - 09/11/2015
USC PHARMA SA CHAUSSEE DE TUBIZE, BELGIUM - EIR, CORR
01/01/2017 - 01/27/2017
HHSF223200850014I HHSF22301001T
K172848
13544327 13544762 13825252 ETC
CARTER WALLACE RECS RE TALC IN CONDOMS 01/01/1992 - 12/31/1996

FOIA LOGS OF CLOSED REQUESTS FOR 483 MARCH 2018
GALAXY SURFACTANTS LTD, INDIA - 483 3/30/18
TERIPARATIDE CASES
FOIA LOG MARCH 2018
DR REDDY'S LABORATORIES LIMITED, SRIKAKULAM - 483, EIR, CORR
04/01/2017 - 04/01/2018
K142003
BUREL PHARMACEUTICALS, RICHLAND, MS - EIR 02/22/2018 -
02/23/2018
K900516
HSVI - MEDICINE
PAMPHLETS
ELECTRO ACUSCOPE MYOSCOPE MEDICAL, CA - CONTACT INFO
3601 HOUMA BLVD, METAIRIE, LA - INSP 6/22/16
DOMESTIC VIOLENCE SUMMARY - XANAX, VALIUM, HALCION
SIX MITES PER SQUARE INCH ON CHEESE FOR FILTH/ADULTERATION -
DOC, PROCEDURES
RECS RE DR WASSIL NOWICKY RE DRUG UKRAIN ORPHAN DESIGNATION

03-1693, COMPLAINT, CORR 01/01/2003 - 04/02/2018
LIST OF 503a, 503b SUBSTANCES BEING REVIEWED ETC 01/01/2017 -
12/31/2018
NOVAN INC RECS RE SB204, PHASE 3 CLINICAL TRIALS, ETC
01/01/2015 - 08/07/2017
DMF SPREADSHEET 01/01/1993 - 12/31/1993
ENFORCEMENT REPORT DATA 10/01/2011 - 04/02/2018
COMMUNICATIONS BETWEEN e5 OR ITS ATTORNEYS AND FDA RE
PHENOBARBITAL 01/01/2014 - 04/02/2018
LIST OF CERTIFIED TE SHELLFISH SHIPPERS
PATRICIA HENSEN EMAIL RE DYMETHAZINE, METHYLSTENBOLONE ETC
11/01/2014 - 04/03/2018
DAILY LOG FOIA 01/19/2018 - 04/03/2018
ANDA 077510
NDA 020222
NDA 019818
DOW CORNING CORPORATION, HEMLOCK, MI - EIR 05/01/2017 -
06/16/2017
DI PAOLA BAKING COMPANY INC, ROCHESTER, NY - INSPECTION RECS
11/20/13, 03/16/17
DAEWOONG PHARMACEUTICAL, KOREA - EIR, CORR 01/30/2018 -
04/03/2018
FDA Briefing Document, Oncologic Drugs Advisory Committee
Meeting, BLA 125646, Tisagenlecleucel, Novartis Pharmaceuticals
Corporation
GANENDEN BIOTECH CORR RE FSV PROGRAM 01/01/2011 - 04/03/2018

CAMPOS BROTHERS FARMS, CARUTHERS, CA - CALIFORNIA EIR
01/15/2018 - 01/19/2018
K131798 K160987 DE NOVO SUMMARY
ANDA 206788 208815 209938
SHULMAN IRB, RESEARCH TRIANGLE PARK, NC - 482 04/03/2013 -
04/03/2018
LIST OF ENTITIES USING MEIJER AS FSVP IMPORTER IN THE ACE
SYSTEM
K011741 K982412
COMPLETE RESPONSE LETTERS TEVA, CELLTRION RE BIOSIMILAR
PRODUCTS 01/03/2018 - 04/03/2018
COASTAL LIFE TECHNOLOGIES, SAN ANTONIO, TX - 483, WARNING
LETTER, ETC 01/01/2013 - 03/31/2018
STERITEC, ATHENS, TX - 483, WARNING LETTER, ETC 01/01/2013 -
03/31/2018
JODY MENIKHEIM, WILLIAM JONES, ROBERT DURKIN ETC EMAILS RE
DYMETHAZINE, METHYLSTENBOLONE 11/01/2014 - 04/03/2018
DR. REDDY'S LABS, INDIA - 483 01/01/2018 - 03/31/2018
BAXTER HEALTHCARE CORPORATION, LARGO, FL - EIR 08/21/2017 -
08/23/2017
ALKEM LAB, DAMAN, INDIA - 483 03/01/2018 - 04/03/2018

NDA 209401
The Jannsen Pharmaceuticals (085055) label for the 300/7.5
Amphetamine and Codeine Phosphate Tablets
DATA RE NUMBER OF UNITS FDA's 503 Facility Product Reporting
website
CSL PLASMA INC, MANHATTAN, KS - EIR 10/01/2016 - 10/31/2016

OBETICHOLIC ACID AERS, FOIA REQUESTS, CASES 12904567,
13097723, 13086204, ETC
NDA 016680
SAMPLE RESULTS 950087
K173388
K171858
NDA 019280
BIOCON LIMITED, BANGALORE, INDIA - EIR 11/01/2017 - 04/04/2018

UPDATED LIST OF NEW DIETARY INGREDIENT NOTIFICATIONS
P170019
NDA 17417
P160045 S001-S003
NDA 012302
CIPLA, INDIA - 483 04/02/2018 - 04/13/2018
CINVANTI AERS
SUSTOL AERS
WAREHOUSE/HOLDING FACILITIES REGISTRATION
OPDIVO - ISRS10686149, 11608642, 11922956, ETC KEYTRUDA - ISRS
13084665, 13891814
NOVARTIS PHARMACEUTICALS CORP - TOBRADEX (DEXAMETHASONE,
TOBRAMYCIN) OPHTHALMIC OINTMENT NDA 50-616 SBA
SORINGROUP USA, ARVADA, CO LIVANOVA PLC, LONDON, UK - SORIN
MITROFLOW AORTIC HEART VALVES EIRS, 483S, POST-APRVL STUDIES,
ETC
ALEMBIC PHARMS - ABILIFY RECS ALEMBIC PHARMS - ADDRESS, NAME
OF CEO
ALEMBIC PHARMS - ABILIFY RECS, AERS
2014-3956, 2015-600, 2016-262, ETC
BOBBEES BOTTLING, LOUISBURG, NC - EIRS 1/1/17 TO 4/2/18
LIST OF DOCTORS WHO TOOK PART IN MERRELL'S CLNCL TRIALS ON
KEVADON
MISSION PHARMACAL CO - THER-GESIC INVESTIGATION RECS
NOVARTIS, MORRIS PLAINS, NJ - 483S 12/17 TO PRESENT
EMAILS, EVIDENCE 02/01/2012 - 04/04/2018
Technical Lead Reports and reviewer notes for the twenty-three
(23) Exemption from Substantial Equivalence Final Orders issued
in September 2017
K170982
Technical Lead Reports and reviewer notes for the four (4)
December 2017
Technical Lead Reports and reviewer notes for the one (1)
January 2018
RECS RE IMPORT REFUSAL 1/5/18 799-3656546-1 THYROID HORMONE
N.E.C. (FDA Product Code: 66JCY99)
CONGRESSIONAL CORR LOG REP RODNEY DAVIS 1/01/2013 - 04/04/2018

DEN170058
NDA 14717
NDA 050790 S-024 S-025
CURRENT LABEL NDA 017884 NDA 017657
K003487
FAERS 3023863, 3390564, 3494539, ETC
NUPLAZID, OCALIVA, EXONDYS 51 ETC AERS
CV for Inpector Niketa Patel
K173388
KITE PHARMA, EL SEGUNDO, CA - 483S 12/17 TO PRESENT
SPARK THERAPEUTICS, WEST PHILADELPHIA, PA - 483S 12/17 TO
PRESENT
SANOFI, REGENERATION PHARMACEUTICAL - DUPIXENT (DUPILUMAB)
AERS, MEDICATION ERRORS 1/17 TO PRESENT
PUMA BIOTECHNOLOGY - NERLYNX (NERATINIB) AERS, MEDICATION
ERRORS 1/17 TO PRESENT
EIR, 483, RESPONSE RELEASED 02/28/2018 - 04/01/2018
FILLED ORIGINAL FDA FORMS 3454, STUDIES ETC TENOFOVIR ETC
RLD HP ACTHAR GEL FDA STUDIES, LAB STUDIES 01/01/2013 -
04/04/2018
CORR RE MEDICAL DEVICE PRE-SUBMISSIONS Q130524 04/01/2013 -
04/30/2015
CORR RE RESEARCH ON VALVELESS LAPAROSCOPIC INSUFFLATOR SYSTEMS
10/01/2017 - 04/04/2018
K180149
CANTRELL DRUG COMPANY, NORTH LITTLE ROCK, AK - COMPLAINTS
11/01/2017 - 01/31/2018
K960425 K892059 K842233
AXOLOTI, BIOLOGIX STEM CELL PRODUCTS, LAB ANALYSIS
UTAH CORD BANK STEM CELL PRODUCTS, LAB ANALYSIS
CORR, EMAIL WITH FDA AND ADDICTION POLICY FORUM OR ADDICTION

POLICY LEADERSHIP ACTION NETWORK 11/01/2017 - 04/05/2018
2017-10376
PNC 1985 LETTER OF NO OBJECTION
K131563
BACKGROUND CHECK RECS 10/08/2009 - 10/09/2009
FINANCIAL DISCLOSURE REPORTING FORMS CDER ADVISORY COMMITTEES
07/29/2008 - 07/12/2016
APPLIED MEDICAL DISTRIBUTION CENTER, MIDDLETON, NY - EIR
12/02/2015 - 03/31/2016
NDA 017011
K151313
K883414
B125387/S37
B125387/S4
B125387/S53
SIMILAC ALIMENTUM EXEMPT INFANT FORMULA SUBMISSIONS
NDA 020330 SBA
K170790
ANDA 076512
FAERS 7378770, 8330103, 8572877, ETC
EDWARDS LIFE SCIENCES, IRVINE, CA - EIR 01/01/2008 - 12/31/2009

FDAAA CLINICAL TRIAL RECS
MIMEDX TISSUE SERVICES, LLC, MARIETTA, GA - COMPANY RESPONSE TO
EIR 01/06/2018 - 02/04/2018
MYLAN NV ATORVASTATIN GENERIC MANUFACTURING SUPPLEMENT AND
BIOEQUIVALENCE STUDY 04/01/2013 - 04/29/2013
ZHEIJIANG CANDORLY PHARMACEUTICAL CO, CHINA - REGISTRATION
RECS 04/17/2015 - 04/17/2015
NDA 019839
SPREADSHEET OF MANUFACTURERS OF ELECTRONIC PRODUCTS WHO
DESIGNATED A US AGENT
CELLTRION, INC - COMPLETE RESPONSE LETTERS 04/01/2018 -
04/06/2018
BLA 125387/S23
BLA 125387/S51
RED MAN ORIGINAL LOOSE LEAF CHEWING TOBACCO ADVERSE EVENTS
WARNING LETTERS, IMPORT ALERTS 01/01/2011 - 04/06/2018
AMERICAN NATIONAL RED CROSS MID ATLANTIC REGION, NORFOLK, VA -
INSPECTION RECS 09/01/2015 - 10/01/2015
ZARBEE INC, DRAPER, UT - 482, 483, AFFADAVITS 2014-2017
WARNING LTR 6/27/14, ETC
SUMMARY OF FDA IMPORT EXAMINATIONS 1/02 TO 3/18
ANDA 209689
PICKER & PHILIPS CT - INVESTIGATION RECS
FDA TECHNOLOGY TRANSFER PROGRAM KNOWLEDGE MANAGEMENT SYSTEM -
SOLICITATION FDA-SOL-14-1135796
ARSENIC IN RICE AND HOT DOGS
PREVIOUSLY RELEASED 483, RESPONSE, 483 MARCH 2018
EIR RELEASED 03/01/2018 - 03/31/2018
483 PREVIOUSLY RELEASED 03/01/2018 - 03/31/2018
FSMA FSVP RELEASABLE DATA ELEMENTS 11/01/2017 - 03/31/2018
SKIN SCIENCES LABORATORY INC, PHILLIPINES - 483 01/30/2017 -
02/01/2017
DASAN E&T KOREA - 483 01/23/2017 - 01/26/2017
COVANCE LABORATORIES, SALT LAKE CITY, UT - EIR, 483, CORR
7/20/17
MYLAN TECHNOLOGIES, INC, ST ALBANS, VT - 483, EIR, RESPONSE
01/01/2013 - 01/05/2018
CURASAN AG, GERMANY - 483 05/08/2017 - 05/11/2017
PFIZER INC, GROTON LABORATORIES, GROTON, CT - EIR, 483, CORR
9/22/17
WOODFIELD PHARMACEUTICAL, HOUSTON, TX - EIR, 483, CORR 4.26.17

ENVIGO CRS, SOMERSET, NJ - EIR, 483, CORR 9/27/17
TOXIKON CORP, BEDFORD, MA - EIR, 483, CORR 7/21/17
SNBL USA, EVERETT, WA - EIR, 483, CORR 9/2/16
ASTRAZENECA PHARMACEUTICALS, COPPELL, TX - EIR, 483, CORR
1/30/17
MICRO CURRENT TECHNOLOGY, SEATTLE, WA - EIR, 483, CORR 1/11/18

GRACE ANALYTICAL LAB, BERKELEY, IL - EIR, 483, CORR 1/30/17
PHILIPS MEDICAL SYSTEMS, CLEVELAND, OH - EIR, 483, CORR 8/18/17

MYLAN PHARMACEUTICALS INC, MORGANTOWN, WV - 483, EIR, RESPONSE
01/01/2016 - 01/05/2018
LETTER REFERENCED IN AAFCO OP 2018
B125387/S43
MPI RESEARCH INC, MATTAWAN, MI - EIR, 483, CORR 4/15/16
ANDA 208697
BLA 125387/S48
K170818 K150771
NDA FARESTON RITUXAN
COGNIS, STEPAN - GRAS STATUS 11/01/2000 - 04/02/2018
OCI POLICY RE ESTABLISHMENT OF DOMICILE OFFICES, JUSTIFICATION

FOR MOVING PERSONNEL, ETC 01/01/2013 - 04/08/2018
INDIVIDUAL CASE REPORTS
KUNSHAN SANYOU PHARMACEUTICAL CO LTD REGISTRATION RECS
07/23/2015 - 07/23/2015
DOLOR TECHNOLOGIES, LLC, SCOTTSDALE, AZ - EIR, 483, CORR
4.17.17
VICTOR L PEREZ, MD, PLANTATION, FL - EIR, 483, CORR 5/22/17
FRESENIUS MEDICAL CARE, OGDEN, UT - EIR, 483, CORR 8/18/17
DOWNING LABS, DALLAS, TX - EIR, 483, CORR 3/3/16
GLYPHOSTATE TESTING DATA AND RESULTS
483'S FOR MELLO-D JERSEYS 01/26/2018 HANFORD, CA AND NOVARTIS
PHARM 11/09/2017 SAN CARLOS, CA
483 FOR MERCK 10/30/2017 RAHWAY, NJ MAQUET MEDICAL SYSTEMS
09/29/2016 WAYNE, NJ MAQUET CARDIOVASCULAR 09/29/2016 WAYNE,
NJ ETC
483 CINCINNATI EYE INSTITUTE 07/18/2001 CINCINNATI, OH PATHEON
PHARM 03/02/2017 CINCINNATI, OH
483 UNIV OF PENN SCHOOL OF VET 01/26/2018 KENNETT SQUARE, PA
QPS 12/16/2016 NEWARK, DE VIRTUS PHARMACEUTICALS 02/01/2018
NEWTOWN, PA
483 EVONIK 08/03/2006 LAFAYETTE, IN CONAGRA FOODS 12/10/2015
INDINAPOLIS, IN ALBANESE CONFECTIONERY GROUP 02/24/2017
MERRILLVILLE, IN
HYLANDS TEETHING TABLES, TELS AERS
CORR BETWEENJ FDA AND PACIRA PHARMACEUTICALS RE LOCAL
ANESTHETIC SYSTEM TOXICITY 01/01/2016 - 12/21/2017
TAIZHOU XINYOU PHARMACEUTICAL & CHEMICAL CO LTD, CHINA
483 CONAGRA 12/21/2017 MARSHALL, MO 483 COCA-COLA 05/24/2017

WRIGHT CITY, MO EIR HOSPIRA 02/15/2018 MCPHERSON, KS
483 GREAT AMERICAN MARKETING 08/04/2017 HOUSTON, TX 483 DAIRY
FARMERS OF AMERICA 05/26/2016 WINNSBORO, TX EIR GE MEDICAL
08/09/2001 SUGAR LAND, TX
483 FLORIDA CRYSTALS FOOD 08/11/2016 SOUTH BAY, FL 483 AND
EIR US STEM CELL CLINIC 12/07/2015 SUNRISE, FL EIR US STEM
CELL CLINIC 5/11/2017 SUNRISE, FL ETC.
NUEROTHERM INC - THERMI GENERATOR SYS AER, 510K, APRVL
12994216, 8819372, 7510289, ETC AER
SYNTRON, CARLSBAD, CA - AUDIT 7/13/16
PUVA (PSORALEN) APRVL RECS
BENTYL ( DICYCLOMINE) AER
NOVARTIS - TOBREX (TOBRAMYCIN) SBA, MED RVW, CHEMISTRY RVW,
LBLG
PERRIGO CO - BACITRACIN SBA, MEDICAL RVW, LBLG
JINAN CHENGHUI-SHUANGDA CHEMICAL CO LTD, ,CHINA - REGISTRATION
RECS 07/31/2015 - 07/31/2015
ELI LILLY - PRASUGREL RECS
TESARO - VARUBI (ROLAPITANT) APRVL, AER, CORR
LAMICTAL (LAMOTRIGINE) LBLG
ZONALON SBA
IMMUNE CHECKPOINT INHIBITORS - AER
TAXOL/PACLITAXEL - FAERS 1992 TO PRESENT
WONDERFUL PISTACHIOS & ALMONDS LLC, LOST HILLS, CA - SALMONELLA
OUTBREAK
NATIONAL BIOLOGICAL CORP, BEACHWOOD, OH - EIR, 483, CORR
3/20/17
JOHNSON MATTHEW PHARMA SERVICES, DEVENS, MA - EIR, 483, CORR
9/2/16
FDA CORR RE ATRIUM MEDICAL CORP - INSPECTION RECS, FOIA
REQUESTS 01/01/2009 - 12/31/2017
JINTAN XILIN PHARMACEUTICAL RAW MATERIALS CO LTD - REGISTRATION
RECS 01/16/2015 - 01/16/2015
OSCOR, PALM HARBORD, FL - EIR, 483, CORR 3/17/16
K163334
Celltrion, Incheon, Korea - 483's
RECS RE SARAH PEDDICORD CORR APPROVAL GENERIC OPIOID PRODUCTS
01/01/2016 - 04/09/2018
VIANOR BIOTECH LTD, CHINA - 483 05/08/2017 - 05/10/2017
ACELLA PHARMACEUTICALS, ALPHARETTA, GA - EIR, 483, CORR 3/8/17

AIRGAS USA, CRAIG, CO - EIR, 483, CORR 4/28/17
K052567
GLATOPA AERS
CANGENE BIOPHARMA, ROCKVILLE, MD - EIR, 483, CORR 3/22/17
ZHEIGIANT SHENGDA PHARMACEUTICAL CO LTD, CHINA - REGISTRATION
RECS 06/23/2015 - 11/04/2016
483 KIM-SENG CO 09/13/2017 COMMERCE, CA EIR
STEMIMMUNE08/04/2017 SAN DIEGO, CA 483 AMGEN 11/03/2017
THOUSAND OAKS, CA ETC
SARAH PEDDICORD DOCS APPROVAL OF GENERIC OPIOID MEDS
CFSAN DOCS RE: ELYSIUM HEALTH COMPOUND SOLUTIONS COSIDIA
IOVATE HEALTH SCIENCES ETC
DATE RANGE: 01/01/2018 - 04/09/2018 RECORDS RE: OUTBREAK OF
SALMONELLA JAN-FEB 2018 ASSOC WITH CHICKEN SALAD PRODUCED BY
TRIPLE T SPEC MEATS
510K K828673 RICH-MAR ULTRASOUND COUPLING LOTION
LUPIN JULY 2017 EIR AND CORR
SUN PHARM RIOMET AERS 4/1/17-4/1/18 AND CORR RE: RECALL
483 EURO DIAGNOSTICS AB, SWEDEN 01/16/2017 - 01/19/2017
LABELS BUMEX (BUMETANIDE) NDA # N018225
NUVARING NDA# 021187 FIELD ALERT/POST -MARKETING SAFETY REPORT
DATE RANGE: 10/03/2001 - 04/09/2018
SIANGZI XINGANJIANG PHARMACEUTICAL CO LTD, CHINA - REGISTRATION
RECS 05/19/2017 - 05/19/2017
DATE RANGE: 01/01/2018 - 03/31/2018 FAERS QVAR REDHIHALER
DATE RANGE: 01/01/2018 - 03/31/2018 FAERS AIRDUO RESPICLICK

DATE RANGE: 01/01/2018 - 03/31/2018 FAERS ARMONAIR RESPICLIK
DAT E RANGE: 01/01/2018 - 03/31/2018 FAERS AZACITIDINE
DATE RANGE: 01/01/2018 - 03/31/2018 FAERS LEVOLEUCOVORIN
CALCIUM
DATE RANGE: 08/01/2017 - 08/31/2017 NDA# 021856, SPP # 11
TAKEDA PHARM CLIN REV, SUMM REV AND ADMIN DOCS
DATE RANGE: 01/01/2018 - 03/31/2018 FAERS CINQAIR
DATE RANGE: 01/01/2018 - 03/31/2018 FAERS PROAIR RESPICLICK

DATE RANGE: 01/01/2018 - 03/31/2018 FAERS ZECUITY
DATE RANGE: 01/01/2018 - 03/31/2018 FAERS AUSTEDO
JIANGXI HENGXIANG PHARMACEUTICAL TECHNOLOGY CO LTD, CHINA -
483 DR. DAVID HYMAN MEMORIAL SLOAN, NY 7/27/17-8/1/17
DATE RANGE: 01/01/2018 - 04/06/2018 FIRST PARTY REQUEST OWN
EIR MEDEGAN MEDICAL, TN
SPREADSHEET OF 483S ISSUED IN MARCH 2018
DATE RANGE: 10/01/1999 - 04/09/2018 DATASET OF INSPECTIONS

DATE RANGE: 01/01/2018 - 04/10/2018 INDIAN FOOD MANUFACTURING
FACILITIES 483S AND EIRS
DATE RANGE : 06/26/2017 - 04/09/2018 RHO EIR, NC
DATE RANGE: 01/01/2018 - 04/09/2018 483S CELLTRION SOUTH
KOREA
DATE RANGE: 07/01/2017 - 04/06/2018 MEDEGAN MEDICAL EIR, WV

DATE RANGE: 11/01/2017 - 04/01/2018 BASHAS AND FSVP INFO-
FIRST PARTY REQUEST
DATE RANGE: 02/20/2017 - 02/22/2017 483 PACIFIC HOSPITAL
SUPPLY, TAIWAN
YANCHENG SUHAI PHARMACEUTICAL CO LTD, CHINA - REGISTRATION RECS
08/19/15
DATE RANGE: 03/01/2018 - 03/31/2018 CFSAN FOIA LOG
BRIGHAM AND WOMENS HOSPITAL, BOSTON, MA - EIR, 483 AND CORR
DATE OF INSPECITON 12/10/15
DATE RANGE: 03/01/2018 - 04/09/2018 CPT 1800306-BY.
DATE RANGE: 06/01/2009 - 06/30/2009 OSCAR FRAZIER EIR
HOUSTON, TX
ETHICON EIR, 483 AND CORR CORNELIA, GA
TOSOH BIOSCIENCE, GROVE CITY, OH -EIR, 483 AND CORR -
INSPECTION 6/28/15
REQUEST LTR AND RESPONSE 2017-502, 2017-1661, 2017-2096, and
2017-4458
REQUEST LTR AND RESPONSE LTR : 2017-4490, 2017-4491, and 2017-
4501
BIOTRIAL BIOANALYTICAL SERVICES, CANADA EIR 2017
COLGATE PALMOLIVE, THAILAND 483 2016 SCIL PROTEINS, GERMANY
483 2017 PERRIGO API ISREAEL 2013 483
CHATTEN CHATTANOOGA, TN - EIR 9/2/16
BOEHRINGER INGELHEIM GERMANY 2017 483 CAMBREX PROFARM ITALY
2017 483 APOTEX INDIA 2017 483
AMGEN SINGAPORE 2017 483 SHIONOGI PHARMA JAPAN 2016 483
HOFFMAN-LAROCHE SWITZERLAND 2016 483
K040073
BAUSCH & LOMB TAMPA, FL 2016 EIR AND INSPECTION CORR
NUPLAZID FAERS REPORT OF DEATH DATE RANGE: 01/01/2017 -
03/31/2018
NEVER TOO HUNGOVER CORR AND FDA REPORTS OR GUIDANCE WITH REGARD
TO SUPPLEMENTS TARGETING HANGOVERS
POSITIVE SKIN TEST COTROL-HISTAMINE RECS
FDA'S 9 SIZE CLASSIFICATIONS FOR FOOD/DIETARY SUPPLEMENT CO TO
DETERMINE INSPECTION FREQUENCY
BLUEGRASS DAIRY AND FOODS, KY 2017 EIR
ADCETRIS CLIN REVIEW BLA 125388/S-080
"SE Review: Evaluation of Multiple Ingredient Changes,
1/14/2015" "Use of Cigarette Designer and other Models to
Predict HPHC Yields in SE Reports, 02/17/2016"
K112692
PALIPERIDONE (PALIPERIDONE) | ANDA #202645 | BIOEQUIVALENCE
SECTIONS
JANSSEN PHARM, GA 2017 EIR
NUTRIZONE RECS (SEE ATTACHED)
AKORN PHARM 483 IL, NJ, NY, SWITZERLAND, INDIA
REZULIN, AGRYLIN, AND PRANDIN RECS 1997
PALIPERIDONE (PALIPERIDONE) | ANDA #203802 BIOEQUIVALENCE
SECTION
LANTUS ISR's: 3831104, 3792319, 3804599, 3901992, 3761724,
3741058, 3830910, 3851817, AND 3864143- SEE ATTACHED
BLINCYTO SUMMARY REVIEW
ALKEM LAB AMALIYA, INDIA 483 MARCH 2018
GLENMARK BADDI, INDIA - 483, EIR 05/01/2015 - 01/04/2018
VASUDHA PHARMA CHEM, PARAVADA, INDIA 483 2017
SELDER MEXICO 483 2016 HENAN DONGTAI PHARM CHINA 483 2015
CAMBREX PROFARMACO ITALY 483 2015
K112791, K083508, K130795, K111992, K113842

K141141 AND K132817
MERIDIAN BIOSCIENCE, CINCINNATI, OH - RECS RE OP ID 68932 BPD

FOR MIMEDX, MIMEDX TISSUE SERVICES AND SURGICAL BIOLOGICS
SURGICAL DAVINCI ROBOT RECS 04/11/2014 - 04/10/2018
CPT1800441-BY - CPT1800341-BY
MIMEDX GROUP INC, MIMEDX TISSUE SERVICES, MARRIETTA, GA - 483
RESPONSE, EIR, CORR, ETC 01/01/2016 - 03/19/2018
(PMA) P020002 THINPREP IMAGING SYSTEM
APPCO PHARM , NJ 2015 483 EIR APPCO PHARMA, NJ 2014 EIR
APPCO, NJ 2016 EIR
K173682
K122904
COMMUNICATIONS WITH AMAZON.COM INC RE MICRO-NEEDLES 01/01/2017
- 01/04/2018
GLYPHOSTATE TEST DATA AND RESULSTS
ALBANESE CONFECTIONARY, MERRILLVILLE, IN 2017 483
VAERS -FIRST PARTY 07/24/2015 - 10/24/2015- SEE ATTACHED
CAPILLARYS NEONAT HB (PN 2006) K091283
SALMONELLA TEST RESULTS MENTIONED IN ARROW RELIANCE, TUKWILA,
WA - WL
K080219
K170810
K031838
CHAPUIS, AUDE, MD (FRED HUTCHINSON CANCER CENTER) 2017 EIR, 483
AND CORR SEATTLE, WA
VRBPAC MTG GUARDASIL 2006 LIST OF MEMBERS, CONFLICT OF INTEREST
RECS
DERMA PEN, LCC, SALT LAKE CITY, UT - COMMUNICATIONS,
INSPECTIONS ETC 01/01/2013 - 01/01/2018
2013-7752.
REQEUST LETTER AND RESPONSE 2013-7769, 2013-5142, 2013-7794,
and 2013-8343
REQEUST LETTER AND RESPONSE 2013-7769, 2013-5142, 2013-7794,
and 2013-8343
2015-8393
2014-2070
2017-9437
2016-8405
REQUEST LTR AND RESPONSE 2018-143 AND 2018-2045
17-SW-00078-SWH SEE ATTACHED
Ozonifocarion, ozone, ozone for food, ozone as an Antimicrobial
Agent for the Treatment, Storage and Processing of Foods in Gas
and Aqueous Phases
TAISHAN CITY CHEMICAL CO LTD, CHINA - REGISTRATION RECS
06/12/2015 - 06/12/2015
UNITED CATERING OPERATIONS, HOUSTON, TX, NEWARK, NJ, CLEVELAND,
OH ETC - INSPECTION RECS 01/01/2017 - 04/10/2018
DR SCHOLL'S CORN OR CALLUS REMOVERS - AERS, WARNING LETTERS,
STUDIES ETC
FOIA LOG OBALON THEREPEUTICS INC 01/01/2017 - 04/10/2018
FUJIWASA CHICAGO, IL ROSEMONT, IL -483 10/15/1991 - 12/15/1991

Documents regarding Essure Citizen Petition
RECS RE THE INFLUENCE OF BODY SIZE DESCRIPTORS ON THE
ESTIMATION OF KIDNEY FUNCTION IN NORMAL WIEGHT, OVERWEIGHT,
OBESE, AND MORBIDLY OBESE ADULTS
NDA 208434
BAXTER PHARMACEUTICAL SOLUTIONS, LLC, BLOOMINGTON, IN - 483,
EIR 07/10/2017 - 07/19/2017
NDA 208255 SBA
NDA 017577 LABEL, INSERT
CIPLA, INDORE, INDIA - 483 04/01/2018 - 04/11/2018
ANDA 075079 LABEL, PACKAGE INSERT
REIYO LLC, ST LOUIS, MO - PERMIT, LICENSE TO MANUFACTURE FOODS
01/01/2013 - 04/11/2018

DAIICHI SANKYO PROPHARMA CO, JAPAN - 483 10/01/2017 -
11/30/2017
DAEWOOD PHARMACEUTICAL CO LTD, KOREA - EIR 04/01/2017 -
04/11/2018
SAMSUNG BIOEPIS, KOREA - 483, EIR 04/01/2014 - 04/11/2018
ANDA 091646
APPROVAL LETERS NDA 019815, NDA 020449, NDA 020705, ETC
SANCILIO, RIVIERA BEACH, FL - 483 10/01/2017 - 10/31/2017
STRANDS, SEROTYPES OF SALMONELLA PATHOGENIC TO DOGS, CATS
01/01/2014 - 04/11/2018
FOI DAILY LOG 3/5-9-18
FAERS 1123498, 11722043, 11906170, ETC

ANDA 079179 ANDA 204644 ANDA 078340
EISAI CO, JAPAN - 483 09/01/2017 - 09/30/2017
ANDA 206936
the application numbers: 04-18357-18, 04-18359-18, 04-18406-18,
ETC
NDA L125058 L125011 APPROVAL LETTERS

HOLOGIC CORPORATION, MARLBOROUGH, MA - EIR 06/06/2018 -
06/15/2018
JAGLOWSKI, SAMANTHA, MD, THE OHIO STATE UNIVERSITY, COLUMBUS,
OH - 483, EIR, CORR 02/06/2018 - 03/14/2018
OLAPARIB, NIRAPARIB, RUCAPARID AERS
NDA 208587 SBA
NDA 61015
ESTABLISHMENT REGISTRATION AND DEVICE LISTING 05/01/1976 -
04/10/2018
ZYRTEC AERS
HUMAN DRUG WARNING LETTERS, 483 01/01/2018 - 04/11/2018
ANDROGEL RECS 10/01/2011 - 12/31/2015
FDA EXPORT CERTIFICATES FOR DRUGS AUTHORIZED FOR EXPORT TO OR
SALE IN IRAZ BY PFIZER PHARMACEUTICAL LLC 01/01/2012 -
12/31/2015
ARROW RELIANCE INC DBA DARWIN'S NATURAL PET PRODUCTS, TUKWILA,
WA - INSPECTION RECS 01/01/2016 - 04/12/2018
EXCLUSIVITY DECISIONS, RECOMMENDATIONS CBER, CDER ETC
FAERS 11239685 11458114 11741881 ETC
LIFESCAN CLINICAL RESEARCH CENTAUR HOUSE, INDIA - EIR
04/12/2018 - 05/12/2018
DR REDDY'S LABORATORIES LTD, GREAT BRITAIN - EIR, 483
11/01/2103 - 01/31/2014
TRIS PHARMA, MONMOUTH JUNCTION, NJ - EIR, 483, CORR 02/14/2017
- 03/20/2017
NDA 60014
K152754
DIAZEPAM RECTAL GEL ACUDIAL APPROVAL RECS 01/01/1997 -
04/12/2018
LENALIDOMIDE AERS 04/01/1996 - 04/30/2018
MESALAMINE ENEMA APPROVAL RECS 01/01/1987 - 04/12/2018
K161454 K152882 K152482 ETC
CLOBETASOL CREAM, TEMOVATE/TEMOVATE E - APPROVAL RECS
01/01/1999 - 04/12/2018
6971031, 6904118, 6556691, ETC
IND 138202
"Results of Analysis: OCI Case # 15-LAC-701-0357 IE # 15-0357-
22469, FACTS # 931911 CERTIFIED COPY
ANIMAL FOOD FACILITY INSPECTIONS 12/02/2017 - 04/10/2018
INTARCIA THERAPEUTICS, HAYWARD, CA - 483 08/01/2017 -
08/30/2017
RECS PREVIOUSLY RELEASED RE ACTHAR 01/01/1970 - 01/05/2018
PASSPORT ISSUES
RECS REC CONSUMER COMPLAINT 152851
FAERS 5768901 4790584 4790619 ETC
ANDA 200166
DOLE FRESH VEGETABLES INC, SPRINGFIELD, OH - LISTERIOSIS
OUTBREAK INDIVIDUAL RECS
CHOICE RESPIRATORY CARE INC, PA - EIRS, 483S, WARNING LTRS 1/98
TO PRESENT
PRODUCT TAMPERING - INDIVIDUAL RECS
YERVOY (IPILLMUMAB) - ISRS 9290203, 10215316, 10240514, ETC
FILMARRAY GASTROINTESTINA (GI) PANEL K140407
EFFEXOR - HOMICDE RECS
K063379
LETTERS FROM PUBLIC RE KRATOM TO DDI 01/01/2016 - 01/06/2018

WELLBUTRIN - HOMICIDAL INDEATION, PHYSICAL ASSAULT RPTS
LAMICTAL - HOMICIDAL IDEATION RPTS
LISTERIA POISONING - RECS
K140279
ANDREW S FRANKEL MD, LASKY SURGICAL CENTER, BEVERLY HILLS, CA -
RECS
BIOPRO - ZIRALLOY MODULAR FEMORAL HEADS MAF-408 MASTER FILE
2017-6517, 2017-8225, 2017-8237, ETC
NATROL - 5 HTP CMPLNTS, RECALLS, INVESTIGATIONS, ETC
RUDULFO SUAREZ MARTINEZ - ENTRY NUMBER NYX01166705
GAMA-GO INC - ENTRY NUMBER 41003000688
K021185
ANI PHARMACEUTICALS INC - CORTICOTROPIN RPTS, MEMOS, MTGS, ETC
7/17 TO PRESENT
ANI PHARMACEUTICALS INC - CORTICOTROPIN MTGS ELECTRONIC
CALENDAR ENTRIES 7/17 TO PRESENT
CONGRESSIONAL CORR 1/1/07 TO 4/8/18
BIG HEART PET BRANDS, PA - 483, 482 01/01/2018 - 04/12/2018
PROAIR HFA PHASE 2 CLINICAL TRIAL RACIAL COMPOSITION DATA
01/01/1979 - 12/31/1981
EVIDENCE RECS
2017-41 2017-42 2017-65 2017-66 2017-67 2017-68 2017-69 2017-
70 2017-71 2017-72
SOYLENT - COMPLAINT RECS
K990560, K963807
NDA 209139
SPREADSHEET OF ALLEGATIONS OF REGULATORY MISCONDUCT CDRH
01/01/2017 - 12/25/2017
HAIMEN PHARMA INC, CHINA - EIR 01/01/2017 - 01/05/2017
NDA 019773 ANDA 074880
EMAILS SENT BY MITCH ZELLER, MATHEW HOLMAN THAT REFER TO OR
MENTION SCOTT GOTTLIEB 12/12/16, 3/10/17, 5/9/17
GILEAD SCIENCES, IRELAND UC, IRELAND - 483 11/01/2017 -
11/30/2017
MILBAR LABORATORIES, INC, EAST HAVEN, CT - 483 12/01/2017 -
12/31/2017
TALC RECS
K001491
BASF, QUINCY FL - EIR 10/26/2015 - 12/31/2015
FDA MEETINGS WITH BAYER RE ESSURE
BLA 125557/S-013
BOSTON SCIENTIFIC CORPORATION, SAINT PAUL, MN IMMUCOR GTI

DIAGNOSTICS, INC, WAUKESHA, WI ETC 483 01/04/2010 - 09/22/2017
HAIMEN PHARMA CO LTD, CHINA - 483 09/01/2017 - 09/11/2017
FSVP RECS GLENDALE WAREHOUSE & DISTRIBUTION
K9 NATURALS RECALL TESTING RECS 01/01/2018 - 04/13/2018
INDIVIDUAL RECS
NIPRO PHARMA CORPORATION, JAPAN - 483 09/01/2017 - 12/31/2017

RECS RE ANTINOL
BAYER OY, FINLAND - 483 04/01/2016 - 04/30/2016
SUMITOMO CHEMICAL CO LTD, JAPAN - 483 12/01/2017 - 12/31/2017

DAILY LOG 3/5-9/18
EMAIL RECS
BRAMMER BIO, LLC, ALACHUA, FL, DEXTRUM LABORATORIES, MIAMI, FL
- 483 03/16/2015 - 02/12/2016
DAILY LOG 3/5-9/18
DAILY 3/19-23/18
RECS, CORR, RE REGISTRATION, APPROVAL OSEOCHONDRAL ALLOGRAFTS
PRESERVED WITH THE MISSOURI OSTEOCHONDRAL ALLOGRAFT
PRESERVATION SYSTEM 01/01/2010 - 04/13/2018
RECS RE NONTUERCULOUS MYCOBACTERIUM, INVESTIGATION RE SORIN OR
LIVONIA HEATER COOLER MACHINES
K170825 K123849 K133037 ETC
LANTUS, LANTUS SOLOSTAR - AERS, CORR
DR REDDY'S LABORATORIES, VISAKHAPATNAM, INDIA - RESPONSE TO 483

FOIA REQUESTS JAN 2018 01/01/2018 - 01/31/2018
ILUMYA APPLICATIONS, CORR, MEETINGS ETC
LANTUS CORR WITH MANUFACTURER, CORR WITH VA, DATA
JOHNSON MATTHEY PHARMA SERVICES, DEVENS, MA - 483, WARNING
LETTER 01/01/2010 - 04/15/2018
ATIVAN, LIBRIUM AERS
IMMUNOMEDICS, MORRIS PLAINS, NJ - 483, WARNING LETTER
01/01/2008 - 04/15/2018
BSP PHARMACEUTICALS SPA, ITALY - 483, WARNING LETTER
01/01/2010 - 04/15/2018
BOTOX, BOTOX COSMETIC - AERS 04/01/2015 - 04/16/2018
EMAIL RECORDS
RECS RE TEEN JUULING 01/01/2016 - 04/15/2018
CHR. HANSEN, DENMARK - EIR
INFORMAL OPINIONS FROM FDA RE CLASSIFICATION OF COLORS AS FRUIT
JUICE, VEGETABLE JUICE
RLD, THORAZINE, NDA 009149 LABELING
VACANCY ANNOUNCEMENTS, DETAILS GS13 MANAGEMENT ANALYSIS
POSITION WORKFORCE RELATIONS DIVISION OF HUMAN RESOURCES
UNDER OFFICE OF OPERATIONS 12/01/2017 - 04/10/2018
FDA WIDE, OFFICE OF OPERATIONS REASSIGMENT PROCEDURES
12/01/2016 - 04/10/2018
FAERS RECS 11894395 11993543 12957155 ETC
ANNOUNCEMENTS TO OHR EMPLOYEES RE MANDATORY EEO TRAINING IN
PREPARATION FOR PERFORMANCE YEAR 2018 PERFORMANCE STANDARDS
12/29/2017 - 04/10/2018
COVIDIENN LLC - CORR, APRVL, 510K, ETC
CEREBRAL PALSY - INFO
JAMIESON - DOCS 1/2018 TO 3/31/18
UNCLE HARRYS NATURAL PRODUCTS - REMINERALIZATION KIT CMPLNTS,
CAERS, RECALL
ACTAVIS ANDA 08-697APRVL
CMPLNT 149745
NJ DEPT OF HEALTH & SENIOR SERVICES - CONTACT
ATNAHS PHARMA US LTD - NAPROXEN (NAPROSYN) SBA, MEDICAL RVW,
CHEMISTRY RVW, LBLG
ROBINUL NDA 17-558
NDA 206814 MOST RECENT LABEL
KINDER SURPRISE CANDIES - RECS
ANDA 61015, NDA 19574
Smallbatch Pets Lot D032 UPC code 705105970974 TESTING RECS

Smallbatch Pets Lot E058UPC code 705105970974 TESTING RECS
Vital Essentials Freeze-Dried Beef Toppers with Lot #13815,

Best By 6/4/19 & Best By 6/20/19 and "Vital Essentials Frozen
Beef Chub Entre for Dogs, 5 lb. with Lot #13816, Best By
12/27/18 LAB RESULTS
RECS RE FDA DECISIONMAKING REGARDING THE TERM NATURAL FOR THE
PURPOSES OF FOOD LABELING
AUROBINDO PHARMA, UNIT I, HYDERABAD 483 04/16/2018 - 04/20/2018

NDA 009388 LABELING FOR RLD, DIAMOX
VAREX IMAGING CORP, LIVERPOOL, NY - 483 3/8/2018
NEVRO CORPORATION, REDWOOD CITY, CA - INSPECTION RECS 3/16/18

K061556
PREDICTIVE BIOTECH, SALT LAKE CITY, UT - 483 10/18/2017 -
10/23/2017
CPT1800262
KINDER SUPRISE CANDIES - RECS RE BAN FOR SALE IN US 01/01/1995
- 01/01/2018
SIEMENS HEALTHCARE DIAGNOSTICS, INC, LOS ANGELES, CA ETC - 483
11/10/2003 - 08/10/2005
UNITED SAFETY AGENTS FSVP RECS 02/15/2018 - 05/15/2018
CUSTOM ULTRASONICS RECS 01/01/2010 - 04/16/2018
K143570
SUBMISSIONS, CORR RE TALC BETWEEN FDA AND JOHNSON & JOHNSON ETC
01/01/1950 - 04/16/2018
K180023
CIPLA LTD, INDORE, INDIA - 483 04/02/2018 - 04/13/2018

PHARMEDIUM SERVICES, LLC, LAKE FOREST, IL - CLEVELAND, MS,
DAYTON, NJ ETC - 483 11/01/2016 - 12/31/2017
3313135, 3310846, 3154789 ETC
LA MONICA FINE FOODS, MILLVILLE, NJ - EIR, 483 01/01/2010 -
04/17/2018
VAERS RECS
CORR RE APRIL 2018 RECALL OF RJ REYNOLDS VUSE VIBE POWER UNITS
01/01/2018 - 12/31/2018
NDI 1041
MYLAN LABORATORIES, BANGALORE, INDIA - 483 03/01/2018 -
03/31/2018
K950270
MYLAN, MAHARASHTRA, INDIA - 483 9/2016
K150951
DSM Nutritional Products in relation to the FAP proposing safe
use of Schizochytrium sp. dried algae as a source of
docosahexaenoic acid for use in standard pelleted foods for
adult dogs
FRESENIUS KABI COMPOUNDING, LLC, CANTON, MA - INSPECTION RECS
12/05/2017 - 01/08/2018
INDIVIDUAL RECS
FRIENDS OF CANCER RESEARCH - EMAILS, MTG AGENDAS, TALKING
POINTS, ETC
2018-2805
ZIMMER BIOMET, WARSAW, IN - EXHIBITS, ATTACHMENTS
VAERS RECS
NDA 021762
DATA RE MAMMOGRAPHY FACILITIES
AARTI DRUGS LTD, INDIA - 483 12/01/2017 - 12/19/2017
SUVEN LIFE SCIENCES LTD, INDIA - 483 02/01/2018 - 02/15/2018

2018-2804
Supplement 125514/S-14 for Keytruda
CYTOSPORT INC, HORMEL FOODS CORP - MUSCLE MILK PRODUCTS RECALL
6/16
CEFUROXIME CEPHALOSPORIN AERS
SAURAV CHEMICALS LIMTED, INDIA - 483 03/01/2018 - 03/31/2018

MILO'S KITCHEN BEEF TREATS TEST RESULTS 03/28/2018 -
04/17/2018
HETERO DRUGS, INDIA - 483 03/01/2018 - 03/31/2018
PACIRA PHARMS - EXPAREL NDA 22-496/S009 SBA, RVWS
IND 12,365
RECS BETWEEN FDA ATTORNEYS AND PACIFIC NW LAB 10/31/2017 -
03/30/2018
FAERS 14335122 14330236 14327248 14295639 14285077
RECS RE STOKES PHARMACY COMPLAINTS, ETC
K163620, K132360, K120944, ETC
K040780
DIETARY SUPPLEMENT REGISTRATION RECS ETC
Sun Chlorella USA, Corporation's pet product, REJUV-A-WAFERS

SYNCARDIA SYSTEMS, LLC, TUCSON, AZ - 483, EIR, CORR 08/14/2017
- 08/18/2017
NDA 019185
2018-1867
K905285, K911189 & K913185
VEGE KURL, INC, GLENDALE, CA - EIR 05/02/2017-05/05/2017
K062611
RECS RE ALLERGAN INC V. SYNERGY PHARMACEUTICALS ETC
ADV COMM TRANSCRIPT SHINGRIX 01/01/2017 - 12/31/2017
L125011, N019815, N020449, ETC
ANESTHETIC AND ANALGESIC DRUG PRODUCTS ADVISORY COMMITTEE
MEETING TRANSCRIPT 02/14/2018 - 02/15/2018
FCN 1841
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
HEMOCUE HB 201 DM SYSTEMS, ETC
JOHN GONZALEZ CV
ORPHAN DESIGNATION RECS RIASTAP
DEN170046
GREEN CROSS CORPORATION, KOREA - 483, CRL
DEN170073
Real Progress in Food Code Adoptions report
NDA 017871
BLUEGRASS DAIRY AND FOODS, INC, DAWSON, MN - EIR, 483, PHOTOS
01/02/2017 - 04/19/2017
EXCEL SPREADSHEET MEDICAL DEVICE 483S CHINA, GERMANY, SWEDEN,
FINLAND MEDTRONIC, BAXTETR, INVACARE, ETC 01/01/2013 -
04/18/2018
CACHE COMMODITIES INCORPORATED, OGDEN, UT Y WAYNE FARMS LLC,
GUNTERSVILLE, AL ETC - EIR
DAEWOONG PHARMACEUTCICAL CO LTD, KOREA - EIR 01/02/2017 -
06/30/2018
INTERNAL AFFAIRS RECS
PMTA IQOS MARLBORO HEATSTICKS
AG CHOICE FEED & GRAIN, EMPORIA, KS ARROW RELIANCE, TUKWILA,
WA - EIR
K173669
CMIC CMO UCA CORPORATION, CANBURY, NJ - EIR, 483, CORR 2/13/15

HUETIS MACHINE CORPORATION, BRISTOL, RI - EIR, 483, CORR
9/15/17
ZOSTAVAX HEARING TRANSCRIPTS 01/01/2005 - 12/31/2006
IIT RESEARCH INSTITUTE, CHICAGO, IL - EIR, 483, CORR 10/26/16

AZTEX ENTERPRISES LTD, ONTARIO, CANADA 483 06/12/2017 -
06/13/2017
HEBEI PUKANG MEDICAL INSTRUMENTS CO, CHINA - 483 01/09/2017 -
01/12/2017
SRI INTERNATIONAL, MENLO PARK, CA - EIR, 483, CORR 5/27/16
UNIQUE INSTRUMENT, BRIDGEPORT, MI - EIR, 483, CORR 11/1/17
XENOMETRICS, STILWELL, KS - EIR, 483, CORR 7/15/16

DEN180001 IDX-DR
VAMSI LABS, INDIA - 483 03/01/2018 - 03/31/2018
CAP TITANIUM DIOXIDE, ETC
ANDA 207550
RECS RE SALMONELLA OUTBREAK PRE-CUT WATERMELON, CANTALOUPE ETC
01/01/2017 - 04/19/2018
GLENMARK PHARMACEUTICALS LTD, PUNE, INDIA - 483 03/01/2018 -
03/31/2018
DEN170047
FY17 FOREIGN SUPPLIER VERIFICATION PROGRAMS INSPECTIONS 8/31/17
Type C feed assay method for Stenorol (halofuginone HCl) in the

feeds of chickens (NADA 130-951) and turkeys (NADA 140-824)
FCN 1841
DEN150028 K161038 K142427
KETTENBACH GMBH & CO KG, DREVE OTOPLASTIK GMBH, VOCO GMBH, ETC
- 483S, 493 RESP LTRS
MARKTEN E-VAPOR AERS
DAEWOONG, SOUTH KOREA - FMD145 11/01/2017 - 04/20/2018
K932402
K921074
IMITREX 9594515, 9909616, 10103074, ETC
ANDA 077066 ANDA 202250
K153542
MARIN BREAST HEALTH CENTER, NOVATO, CA - INSPECTION RECS
01/01/2017 - 12/31/2017
NDA 016636
ANDA 78-396
DRUG MASTER FILE 14498
MYLAN, MORGANTOWN, WV - INSPECTION RECS 01/01/2017 - 04/19/2018
ENHANCED ATHLETE, IRONMAG LABS - SELECTIVE ANDROGEN RECEPTOR

MODULATORS INVESTIGATION IN SALES, PRODUCTION AND MARKETING
K031759
BLA 125610
DEAWOONG PHARMACEUTICAL CO LTD, SOUTH KOREA - RESP TO 483 11/17

AKERS BIOSCIENCES - RAPID ASSAY FOR CHLAMYDIA SAFETY,
EFFECTIVENESS, 510K APPLICATION, ETC
TENS ELECTRO-ACUSCOPE DEVICES - USE BY UNLICENSED PRACTITIONERS

OCEAN KING & SONS INC - ENTRY NUMBER D0108559523
JAY CALVERT, ROX CLINIC, BEVERLY HILLS, CA - RESEARCH WITH UNIV
OF SOUTHERN CALIFORNIA
DR AZRA RAZA, RUSH CANCER CENTER, ST LUKE'S MEDICAL CENTER -
PROTOCOL MDS 99-14, IRB AUDIT
ECKERT & ZIEGLER - RU-106 EYE APPLICATORS K931393
HP ACTHAR GEL, ACTH, ADRENOCORTICOTROPIN, ETC - FOIA REQUESTS

OHR STAFF EMAILS
OFFICE OF OPERATIONS EMAILS
2017 RJ Reynolds/American Snuff Product Listing (June and
December) and any recent HPHC Reports/Ingredient Listing
specifically for Grizzly Dark Select
MEDWATCH RECS
K132671 CERTIFIED SE LETTER
QT ULTRASOUND LLC, NOVATO, CA - INSPECTION RECS, COMPLAINTS
01/01/2017 - 12/31/2017
K841762
STARKIST, AMERICAN SAMOA - EIR, 483 01/01/2010 - 04/18/2018

ASTRA ZENECA ORPHAN DESGINATION RECS ROSUVASTATIN
STARKIST, ECUADOR - EIR, 483 01/01/2010 - 04/19/2018
INDIVIDUAL RECS 02/01/2012 - 04/18/2018
QT ULTRASOUND LABS, INC, NOVATO, CA - INSPECTION RECS,
COMPLAINTS 01/01/2017 - 12/31/2017
CHANTEST CORPORATION, CLEVELAND, OH - EIR, 483, CORR 5/6/16
PFIZER INC, MCPHERSON, KS - 483 10/01/2017 - 01/08/2018
KARL STORZ ENDOSCOPY AMERICA INC, KENNESAW, GA - EIR
01/26/2015 - 01/28/2015
KARL STORZ ENDOSCOPY AMERICA INC, KENNESAW, GA 06/20/2017 -
06/21/2017
PROLIA RECS
483s issued by the Kansas City DO in March 2018
483s issued by the Los Angeles DO in March 2018
483s issued by the Minneapolis DO in March 2018
McDermott Laboratories/Mylan Dublin Respiratory inspection
information, Dublin, Ireland
483s issued by the New Orleans DO in March 2018
483s issued by the New Jersey DO in March 2018
483s issued by the New England DO in March 2018
PFIZER, MCPHERSON, KS - 483 1/1/17-12/31/17
483s issued by the New York DO in March 2018
483s issued by the San Francisco DO in March 2018
483s issued by the San Juan DO in March 2018
483s issued by the Seattle DO in March 2018
483s issued by the CDER International Operations Office in
March 2018
8334770 8395642 8673572 ETC
ANDA 208825 ANDA 209718
K952877
AMERICAN PRECLINICAL SERVICES, MINNEAPOLIS, MN - 483, EIR
03/19/2018 - 04/13/2018
AMERICAN LABORATORIES INC, OMAHA, NE - MOST RECENT INSPECTION
11/27/2017 - 12/01/2017
SE0013536 SE0013537
PHYSIO-CONTROL, REDMOND, WA - EIR 11/27/2017 - 12/15/2017
NDA 018620
LINE ITEM LEVEL DETAIL ON PURCHASE ORDERS MADE OVER LAST 24
MONTHS THROUGH FDA INTRAMALL
RECS RE TRANSVAGINAL MESH 01/01/2008 - 03/15/2018
PALL EUROPE LTD, UK - EIR MOST RECENT 01/01/2014 - 04/01/2018

SCHOTT NORTH AMERICAN, LEBANON, PA - EIR MOST RECENT
01/01/2014 - 04/01/2018
CV for Douglas A. Campbell
March 2018
483s issued by the CDRH International Operations Office in
March 2018
483s issued by the Cincinnati DO in March 2018
STOCKERT HEATER COOLER SYS K052601, CINCINNATI SUBZERO
HEMOTHERM K811742, JOSTRA AB HEATER COOLER UNIT 30 K031544,
DUAL COOLER HEATER K001520
483s issued by the Dallas DO in March 2018
483s issued by the Denver DO in March 2018
483s issued by the Detroit DO in March 2018
Tobacco Product Standard for Nicotine Level of Combusted
Cigarettes
K100268 FIRST PARTY
K010139, K101997, K140178, ETC
483s issued by the Florida DO in March 2018
483s issued by the Baltimore DO in March 2018
483s issued by the Atlanta DO in March 2018
TOPICAL KETOCONAZOLE, ORAL KETOCONAZOLE AERS
MEDLINE INDUSTRIES INC - HEMO FORCE DVT COMPRESSION SLEEVE

K170415, BIO COMPRESSION SYSTEMS INC - SEQUENTIAL CIRCULATOR
SC-2004FC-OC K171793, DEVON 24 - MEDICAL PRODUCTS LTD K170814.
TACTILE SYS TECHNOLOGY INC - FLEXITOUCH SYS K170216
Pre-clinical and post-marketing studies demonstrating safety of
vaccinating premature infants
Animal dose escalation studies used to determine alum adjuvant
safety levels in preemies and infants/children
DESOGESTREL, NORGESTIMATE, DROSPIRENONE AERS
FCN 459
PETITION FOR STYRENE-MALEIC ANHYDRIDE COPOLYMERS
FCN 1699
SUVEN LIFE SCIENCES, INDIA - 483 02/01/2018 - 04/30/2018
FRESENIUS KABI, GRAND ISLAND, NY MELROSE PARK, IL - 483 ETC
01/01/2017 - 04/24/2018
13277136 13277135 13277125 ETC
NDA 012223 SBA
CMPLNT 151834
XIFAXAN AERS
FAERS GLATOPA, AUSTEDO, ZECUITY ETC
FOIA RQUESTS ROSE ACRE FARMS 09/01/2017 - 04/23/2018
ANDA 072512 ANDA 072513 ANDA 072514
CORR BETWEEN FDA AND GW PHARMACEUTICALS RE DEA SCHEDULING OF
EPIDIOLEX 01/01/2014 - 04/23/2018
HALPERIDOL, BENZTROPINE - AER
FINANCIAL DISCLOSURE FORMS & CONFLICT WAIVER DOCUMENTS

EMAILS FROM CDC EMPLOYEE 12/14 TO 10/31/15 REGARDING CHIPOLTE
MEXICAN GRILL
HOSPIRA - MARCAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
NDA 01-696
SPORANOX (ITRACONAZOLE) APRVL, RVWS NDA 22-484
MIMEDX GROUP INC, FL - RECS 8/28/13 TO PRESENT
MERCK - ZOSTAVAX NDA
INITIAL PUBLIC HEALTH IMPACT ASSESSMENT CONDUCTED 2013
DIABETES, OBESITY, HYPERTENTION ETC 04/01/2018 - 04/22/2018

VAERS RECS
GATE GOURMET, LSG SKYCHEF, MIAMI, FL - INSPECTION RECS
01/01/2015 - 04/23/2018
PMA 030002, Trulign Toric lens
DEN180001
MC RESOURCE DEVELOPMENT DBA PINE VALLEY 09/01/2015 -
01/31/2016 SPRING, NEW RINGOLD, PA - EIR, ATTACHMENTS
QIAGEN SCIENCES LLC, GERMANTOWN, MD - EIR 02/05/2016 -
03/01/2018
LOS ROBLES HOSPITAL, THOUSAND OAKS, CA - FORM 2579 8/1/10 TO
1/1/18
Seeking B Braun Medical Inc. Chemistry Manufacturing and
Controls for the Excel Plastic Container, type III DMF 6460
that was first filed 6/30/1986
K012991 Substantially Equivalent Letter issued on November 29,
2001 (CERTIFIED)
RECS RE INVESTIGATION OF MULTISTATE OUBREAK OF SALMONELLA
BRAENDERUP LINKNED TO ROSE ACRE FARMS SHELL EGGS 09/01/2017 -
04/23/2018
GENETIC TESTING DATE RE MULTISTATE OUBREAK OF SALMONELLA
BRAENDERUP LINKED TO ROSE ACRE SHELL EGGS 09/01/2017 -
04/23/2018
LIST OF CONFIRMED CASES ILLNESS RE MULTISTATE OUTBREAK OF
SALMONELLA BRANERUP LINKED TO ROSE ACRE SHELL EGGS 09/01/2017
- 04/23/2018
RECS RE TESTING ANALYSIS NO HIDE PRODUCTS EARTH ANIMAL
VENTURES, SOUTHPORT, CT 06/01/2017 - 06/01/2018
K150361
K143751
FAP 4M4417
CELDLTRION INC, KOREA - 483 05/01/2016 - 12/21/2017
GENUS LIFESCIENCES GOPRELTO (COCAINE HYDROCHLORIDE NASAL
SOLUTION) NDA 20-9963
DEN180001
SUMMARY OF INSPECTIONS 09/22/2017 - 04/23/2018
VETERINARY STUDIES, AERS CARPROFEN IN DOGS 01/01/1988 -
04/24/2018
CORR RE THE SAFETY OF THE PLANT-DERIVED INGREDIENT "HEME," AN
IRON COMPOUND CREATED BY IMPOSSIBLE FOODS, INC. FOR USE IN ITS
VEGAN BURGERS 01/01/2016 - 04/25/2018
K943998
THE DOW CHEMICAL COMPANY, MIDLAND, MI - EIR 04/21/2015 -
04/24/2018
K101298 FIRST PARTY
FOIA LOG 2017
MONARCH PCM, LLC, FORT WORTH, TX - EIR, 483, RESPONSE
02/01/2018 - 04/25/2018
INSPECTION FORMS USED BY INSPECTORS OF ANIMAL FOOD FACILITIES
TO VERIFY COMPLIANCE WITH GMP REQUIREMENTS
LIST OF CLOSED FOIA REQUESTS 01/01/2017 - 04/24/2018
CORR, RECS RE EBAY SALE OF JUUL PRODUCTS, OTHER TOBACCO
PRODUCTS 04/02/2018 - 04/30/2018
DMF 6460
DMF 6460
GRAS 737
ADVERSE EVENT RECS
FCN 1738
2017-7641
K091272, K021446, K021442
CLOSED REQUESTS FOR 483 APRIL 2018
FOIA REQUEST LOG APRIL 2018
FAREVA ZONE, FRANCE - 483, EIR 05/01/2017 - 12/01/2017
ELIXA STATISTICAL REVIEW
All EIRs for crude heparin sodium manufacturers located in

China from January 1, 2008 until the date of this request 483
issued to Chongqing Imperial Bio Chem (inspection dates Sept
22-25, 2008)
ULORIC AERS 7209484 8403952 8403952 ETC
INSPECTION CLASSIFICATION DATA 10/01/2011 - 03/31/2018
BLA 125156 S 110, 112, 117
METHOCARBAMOL RECS RE 48 HOUR DRUG FREE INTERVAL IN LABELING

ANDA 208390
2017-8753, 2017-9822
ANDA 205078
EIR, 483, CORR AKORN, SOMERSET, NJ AMITYVILLE, NY HATLINGEN,
SWITZERLAND ETC 01/01/2016 - 04/24/2018
DMF 6460
TESTING PROCEDURES HOMEOPATHIC TEETHING TABLETS, REPORTS ETC
ANDA 062336
SOCIAL MARKETING COMPANY, BANGLADESH, BEIJING WANTAI PHARMACY
ENTERPRISE - IMPORT ALERTS, 483
ZOFRAN TOXICOLOGY, ETC
ADAMAS SBA
FDA TESTING HYLAND TEETHING TABLETS ETC
FREEPORT HOME MEDICAL EQUIPMENT, IL - EIR, 483, WARNING LTR
1/98 TO PRESENT
NDA 021462 S 52 LABEL
K161431
NDA 018485
K171373
K964034
K151068
NDA 019304
VESTA INTERMEDIATE FUNDING INC, FRANKLING, WI - 483 7/20/2017,
10/20/2017
WELLINGTON FOODS, INC, CORONA, CA - EIR 12/05/2017 - 12/13/2017

PHASE 4 PHARMACEUTICAL, LLC AVENTURA, FL - EIR, 483, CORR
04/26/2017 - 05/02/2017
OLYMPIC OXYGEN, WA - EIR, 483, WARNING LTR 1/98 TO PRESENT
ANDA 077007 SBA
NORTHWEST BIOTHERAPEUTICS RECS RE CLINICAL HOLD
SYNGENE INTERNATIONAL, BANGALORE, INDIA - 483 01/01/2018 -
04/02/2018
MYLAN PHARMACEUTICAL, MORGANTOWN, WV - 483 01/01/2016 -
04/25/2018
K173958
K932368 K932366 K932364 ETC
K172186
OHIO LAB PHARMA, KETTERING, OH - EIR, 483, CORR 9/28/17
UNIVERSITY OF SOUTH ALABAMA CHILDREN'S AND WOMEN'S HOSPITAL,
MOBILE, AL - EIR, 483, CORR 6/22/17
IAN M BAIRD, MD, COLUMBUS, OH - EIR, 483, CORR 1/26/17
TAMBRA INVESTMENTS INC, MI - EIR, 483, WARNING LTR, 1/98 TO
PRESENT
BAYER AG, LEVERKUSEN, GERMANY - 483 01/12/2017 - 01/20/2017
FCN 1858
DRUG RECALL DATA 10/01/1999 - 12/31/2017
LIST OF PHARMACEUTICAL COMPANIES RECEIVING PHARMACOVIGILENCE
483 01/01/2015 - 03/31/2018
MANUFACTURING LOCATIONS FOR DRUGS 01/01/2003 - 04/25/2018
HEALTHIUM MEDTECH PRIVATE LIMITED, INDIA MERIL ENDO SURGERY
PVT. LTD. 483 01/01/2010 - 04/25/2018
ANDA 040885 INSERT LABELING
IOPERAMIDE - AERS 1/1/76 TO 12/31/17
PHARMICHEM TESTING SERVICES INC, TINLEY PARK, IL - EIR 2/24/17-
3/16/17
ALBENDAZOLE - PAGE 1 OF THE ANDA CHECKLIST 1/115 TO 3/31/18
VIA CHRISTI HOME MEDICAL & SALINA REGIONAL HOME MEDICAL
SERVICES, KS - EIR, 483, WARNING LTR 1/98 TO PRESENT
ARROWS (JAPAN) UB ANALYZER UA-2 K87115
TRANSVAGINAL MESH - MARKETING, PRODUCT RVWS, COMMUNICATIONS,
ETC
ALBENDAZOLE - ANDA COVER LTRS 1/1/15 TO 3/31/18
PETER THIEL, JIM O'NEIL, BALAJI SRINIVASAN - RECS, CORR, ETC
11/16 TO PRESENT
DANCO LABS - MIFEPREX (MIFEPRISTONE) RU-486 AERS 2005 TO 2018

DANCO LABS - MIFEPREX (RU-486), (CYTOTEC) MISOPROSTOL AERS 2005
TO 2018
ELI LILLY - TRULICITY WARNINGS, SAFETY INFORMATION, AERS, ETC
XTTRIUM LABORATORIES INC, MOUNT PROSPECT, IL - EIR 5/6-25/16

SEROQUEL NDA 20-639 APRVL RECS
REP PETE SESSIONS - CONGRESSIONAL CORR 1/197 TO 4/25/18
UNITED STATES OF AMERICA VS ERIC POTRATZ (CR-15-00236 LHK)
2018-2337
INVOKANA - AERS
TAKHZYRO (LANADELUMAB INJ) - RESEARCH MATERIALS, CORR
DRUG COMPANIES, BLOOD ESTABLISHMENTS, BIOLOGICAL PRODUCT MFRS,
ETC - DOMESTIC AND FOREIGN INSPS 1/1/18-3/31/18
ZIMMER BIOMET, WARSAW, IN - 483 01/01/2017 - 04/27/2018
ZIMMER BIOMET, WARSAW, IN - EIR, 483, CORR 03/05/2018 -
04/26/2018
ZIMMER BIOMET, WARSAW, IN - 483, RESPONSE 11/18/2017 -
04/26/2018
MAQUET CARDIOVASCULAR, WAYNE, NJ - EIR, 483, CORR 9/29/16
ELITECH GROUP SAS, FRANCE - 483 03/27/2017 - 03/30/2017
3M CORPORATION, COLUMBIA, MO - EIR, 483, CORR 2/4/16
CORR BETWEEN NIDA & FDA REGARDING 8 FACTOR ANALYSIS OF
MITAGYNINE & 7 HYDROXYMITRAGYNINE
BAUSCH & LOMB SURGICAL, CLEARWATER, FL - EIR, 483, CORR 4/5/17

BAXTER PHARMACEUTICAL SOLUTIONS, BLOOMINGTON, IN - EIR, 483,
CORR 5/12/16
AIRGAS USA, PUEBLO, CO - EIR, 483, CORR 1/16/17
ETHICON, CORNELIA, GA - EIR, 483, CORR 5/12/17
COVIDIEN, NORFOLK, NE - EIR, 483, CORR 11/15/17
CERNO PHARMACEUTICALS, MIAMI, FL - EIR, 483, CORR 11/17/17
AMPHASTAR PHARMACEUTICALS, RANCHO CUCAMONGA, CA - EIR, 483,
CORR 3/17/17
DEN180001
INDIVIDUAL RECS
SYNGENE, BENGALURU, INDIA - 483 01/01/2018 - 04/26/2018
FAERS 6413861 6462424 6790214 ETC
INNOVATIVE HEALTH SOLUTIONS INC - NSS 2 SYS APRVL
BLA 125557/S013
MERATRAN, ALERTONIC REVIEW RECS
ZIMMER BIOMET, INC, WARSAW, IN - 483 03/01/2018 - 04/26/2018

LEXAMED, TOLEDO, OH - EIR 11/02/2015 - 05/02/2018
NDA 020126
NDA 210-563
APOLLO CARE, LLC, COLUMBIA, MO - EIR 02/01/2018 - 03/31/2018

PACIRA PHARMACEUTICALS, SAN DIEGO, CA - EIR 02/20/2018 -
03/02/2018
HANLIM PHARM CO, KOREA - 483, EIR 01/01/2018 - 05/01/2018
DEXTROMETHORPHAN - AER
DMF 6460
AGILENT NASD, BOULDER, CO - EIR 01/01/2018 - 05/01/2018

CORR BETWEEN FDA AND PFIZER, INC RE PROPOSED CHANGES TO CORE
DATA SHEET FOR DEPO-MEDROL ETC 01/01/2013 - 04/27/2018
PRODUCT QUEST MANUFACTURING, HOLLY HILL, FL - EIR 01/31/2015 -
04/27/2018
K043527 K061903 K072302 ETC
K031804 K041352 K043547 ETC
LIQUID HERBALS MANUFACTURING, LLC DBA LIQUID NUTRA GROUP, SALT
LAKE CITY, UT - INSPECTION RECS ETC
LIST OF INSPECTIONS
CDER IND and NDA data
DESONIDE NDA 01-7010 APRVL
ZIMMER BIOMET, WARSAW, IN - 483, CORR, WARNING LETTER
04/01/2017 - 04/26/2018
ECHO LAKE FOODS INC, BURLINGTON, WI SURPASS, INC, OSCEOLA, WI
- 483 11/27/2017 - 01/11/2018
ANDA 040861
FDA's DARRTS FINAL REPORTS FOR ALL POSTMARKETING REQUIREMENTS

FOR NEW DRUGS AND BIOLOGICS APPROVED SINCE 2008
K-9 KRAVING DOG FOOD TESTING RECS 07/01/2015 - 12/31/2015
NDA 018620
VERICEL CORPORATION PROMOTION OF PRODUCTS CARTICEL, MACI,
EPICEL 04/01/2014 - 04/26/2018
K112877
HHSF223201610122C MOD 4, 5
K143033
SEBALA IRELAND LTD - NAFTIN (NAFTIFINE HYDROCHLORIDE) SBA,
CHEMISTRY RVW, MEDICAL RVW, LBLG
FCN 1753 1800
Documents produced to Food Safety News relating to Evanger's
Dog and Cat Food Co., Inc. and Nutripack LLC from January 1,
2017 to now
NDA 012041/S-043
STN - SE0014279, SE0014280, SE0014281
STN - SE0004087, SE0004088, SE0004094, ETC
CHARLES RIVER, SENNEVILLE, QC - EIR
CHARLES RIVER, RENO, NV - EIR
CHARLES RIVER, SKOKIE, IL - EIR
CHARLES RIVER, RENO, NV - EIR 5/22-26/17
CHARLES RIVER, ASHLAND OH - EIR 7/17-21/17
THERMOTEK - NANOTHERM, VASCUTHERM, VASCUTHERM 2 AER
MEDISCA INC - EIR , INVESTIGATIONS, FORM 2657, ETC
EMJOI TENS DVC K052711
ALBENDAZOLE NDA 1/15 TO 3/31/18
ENTRY NO NL7-0110173-4
CORR BETWEEN REP RANDY HULTGREN & FDA 1/11 TO 4/26/18
AIR SOURCE/AIRGAS - INVESTIGATION
HALOPERIDOL BENZTROPINE - RECALL
TECHNICAL RVWS BY EEOC 2/14 TO PRESENT
CASE NO RA-FDACTP-236-17
Archived Postmarketing Requirements and Commitments Database
files from 2008 to the present
COMMUNICATIONS BETWEEN PAN DRUGS LIMITED AND FDA 01/01/2014 -
01/09/2018
RECS RE PHI ASSESSMENTS, GUIDELINES FOR TOBACCO PRODUCTS, ETC

PHOSPHODIESTERASE 5 INHIBITORS OSE REVIEWS
PHILIP MORRIS INSPECTION RECS
FCN 1445
L'OREAL PROFESSIONAL, PARIS, L'OREAL USA INC REGISTRATION OF
COSMETIC RECS 04/27/2017 - 04/26/2018
Safety of cashew and other substitute milks for feeding to mice
as a supplement to water intake
CATHY L BACKINGER, APRIL BRUBACH, PRISCILLA CALLAHAN-LYON, ETC
CV
SCHWARZKOPF OR HENKEL AG & CO, CULVER CITY, CA - COSMETIC
REGISTRATION 04/27/2017 - 04/26/2018
ENTRY LAB RESULTS #221-3639276-2
MYLAN, MORGANTOWN, WV - 483 01/03/2017 - 04/23/2018
K781967
LIST OF INSPECTIONS FOOD, COSTMETICS 04/01/2008 - 04/30/2018

MELISSA GARCIA CV 04/29/2018 - 04/29/2018
ORANGE BOOK PATENTS 01/01/1984 - 04/27/2018
FDA Regulations on pipe tobacco products
B&R PRRODUCTS, CUTLER BAY, FL - INSPECTION RECS 3/01/2018 -
04/30/2018
NANOPARTICLES IN BABY PARTICLES - 5/16 TO PRESENT
ALBENDAZOLE - FORM 3794 1/15 TO 3/31/18
ELMIRON (PENTOSAN POLYSULFATE SODIUM) NDA 1/15 TO 3/31/18
2018-2915
HYDROXYCUT, JOINT ME, SPEEP MD, ETC - CAERS
RECS RE THE COMMISSARY, PORTLAND, OR SUPER JUGOSO, OAKLAND, CA

- INSPECTIONS, COMMUNICATIONS, ETC 01/01/2012 - 01/09/2018
INDIVIDUAL RECS
CARDIO OPTICS INC - K050808, K062340 1/95 TO 1/1/15
EMAILS BETWEEN FDA & KURT ROSS, DR STACI GRUBER 1/16 TO 5/16
LIST OF INSPECTIONS APRIL 2018
NORTHGATE SUPERMARKET FSVP RECS 01/01/2018 - 03/31/2018
BLA 125387 S 48
K800829 CLEARANCE LETTER
CIPRO LIFE SEATTLE EYE BANK RECS
MICROWAVE OVEN PRODUCT REPORTS 3/15/18 TO PRESENT
PROSOLUS INC, MIAMI, FL - EIR 04/26/16
RECS RE WARNING LETTER AMERICAN PURE WHEY, RALEIGH, NC
01/01/2016 - 01/08/201
ACCUTANE SBA REVIEWS
P030017/S275
AKORN - DATA INTEGRITY RECS, INSPECTION RECS 03/01/2017 -
04/30/2018
BLA 125554
NDA 016295
APPROVAL DATES FOR DRUGS

WALGREENS FSVP RECS
ETC
K133125
PARADIGM REAL TIME SYS P980022 PARADIGM REAL TIME SYS
P98022/S013 PARADIGM REAL TIME INSULIN INFUSION PUMPS
P98011/S031, ETC
ELMIRON - PAGE 1 OF THE ANDA CHECKLIST
DIFFERIN GEL - AERS, APRVL RECS, CORR
HOW MANY DVCS HAVE BEEN IMPORTED INTO THE US IN THE LAST 5 YRS
K062828, K072522 - TESTING STANDARDS, BIOCOMPATIBILITY RECS
ELEVATIONS BRANDS, FRAMINGHAM, MA - EIR 09/09/2016 - 09/23/2016

K131966 K090961
PREVIOUSLY RELEASED 483, RESPONSE, EIR APRIL 2018
KOWA COMPANY, JAPAN - REGISTRATION RECS, INSPECTION REPORTS
VIDEO FOOTAGE
NDA 208780
IFDA-2008-P-0317 FDA-2012-P-0502
KYOWA HAKKO BIO CO LTD, JAPAN - 483
MICROBIOPHARM JAPAN CO, JAPAN - 483 09/01/2017 - 09/30/2017
BIOCON, BANGALURU, INDIA - 483 04/01/2018 - 05/01/2018
OTSUKA CHEMICAL CO, JAPAN - 483 11/01/2017 - 12/05/2017
NDA 008720/ORIG-1
2018-3225
2018-3015
Date Range: 06/02/2016 - 05/01/2018 Provide the name of the
person and/or company that made FOIA Request 2016-8882 for
510(k) submission K152519
510K APPROVAL LETTER AKERS BIOSCIENCES INC., PIFA CHLAMYDIA
K112409
ASPIRE PHARMACEUTICAL, SOMERSET, NJ - EIR 01/01/2015 -
01/09/2018
2018-3306
BIOCON, BAGALORE, INDIA - 483 04/22/2018 - 05/02/2018
License FA1272, Positive Skin Test Control-Histamine, reissued

June 2, 1999, Reference No. 90-0691(original license
application for histamine at 6mg/ml) 1. LARD document 2.
Clinical Review Memoranda 3. SBA
K171120
00P-1213 CITIZEN PETITION
NAMSA MINNEAPOLIS, MN - 483, EIR 01/01/2018 - 05/03/2018
UNIVERSITY OF MINNESOTA RESEARCH ANIMAL RESOURCES, MINNEAPOLIS,
MN - 483, EIR 01/01/2017 - 12/31/2017
EPIPEN, EPIPEN JR MEDWATCH RECS
ERIVEDGE AERS
LIFE EXTENSION, FORT LAUDERDALE, FL - EIR 01/01/2016 -
01/09/2018
K063349 K140789 K051405
RFA-FD-18-013
RFA-FD-18-013
AKORN, DECATUR, IL - 483 ETC 01/01/2018 - 05/03/2018
BIOCON, BENGALURU, INDIA - 483 04/01/2018 - 05/31/2018
BIOCON LIMITED, BANGALORE, INDIA - 483 03/01/2018 - 05/02/2018

BIOCON, BANGALORE, INDIA - 483 04/23/2018 - 05/02/2018
SALMON RIVER FOODS, INC DBA DREAM CHOCOLATE, BOISE, ID - EIR
07/01/2017 - 08/31/2017
TECHNICAL LEAD REPORTS
TECHNICAL LEAD REPORTS, REVIEWER NOTES
KRATOM DEATH REPORTS
ANDA 076550
K092926
ADITYA LABORATORIES, INVADERM, SOMERSET, NJ - EIR, 483,
RESPONSE 01/01/2014 - 05/04/2018
K171356
BIOCON - EIR JUNE 2017
ELMIRON(PENTOSAN POLYSULFATE SODIUM) FORM 3794 1/15 TO 3/31/18

NATIONAL FROZEN FOODS CORP - INVESTIGATION OF GREEN BEANS 1/12
TO 12/31/15
ELMIRON (PENTOSAN POLYSULFATE SODIUM) FORM 356H 1/15 TO 3/31/18

NDA 205489 SBA
IROKO PHARMACEUTICALS LLC - INDOCIN (INDOMETHACIN) SBA.
MEDICAL RVWS, CHEMISTRY RVW, LBLG
FAERS - 4Q2017 CASES
JANSSEN, GURABO, PR - EIR, 483 05/01/2015 - 12/03/2016
MARJON SPECIALTY FOODS, INC, PLANT CITY, FL - EIR 03/13/2017 -
03/15/2017
Guidance for Industry and FDA Staff Intravascular

Administration Sets Premarket Notification Submissions 510(k)
NATURAL AMERICAN SPIRIT CIGARETTES - NOTES, EMAILS, REPORTS ETC
SANTE FE TOBACCO CORR RE WARNING LETTER ETC 05/01/2015 -
05/01/2018
K070961
RICHARD THOMAS EMAILS NARONG CHAMKASEM FINDINGS
ADVISORY COMMITEE RECS PULMOZYME LABELING CHANGE RECS
ZIMMER BIOMET HOLDINGS, WARSAW, IN - CORR, 483 01/01/2018 -
05/01/2018
NDA 022063 SBA
RECS RE MEETINGS KRATOM NEW DIETARY INGREDIENT NOTIFICATIONS

PLAKOUS THERAPEUTICS, WINSTON-SALEM, NC - EIR 01/01/2017 -
05/02/2018
QUEST4 LIFE SCIENCES PVT LTD, INDIA MSN LABORATORIES, INDIA
GLAND PHARMA, INDIA - 483 02/01/2018 - 03/31/2018
RECS RE BLACK BOX WARNINGS : INCREASED MORTALITY IN ELDERLY
PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
VSL#3 AERS
IND-SWIFT LABORATORIES LIMITED, INDIA CODEL INTERNATIONAL, ETC
- 483 03/01/2017 - 10/01/2017
ADV COMMITTEE TRANSCRIPT 02/14/2018 - 02/14/2018
BASF CORPORATION, GEISMAR, LA - EIR 04/01/2015 - 04/30/2018
NDA 209410
NDA 208944
RECS RE CTP MEETINGS WITH RJR
ZEVACOR, SOMERSET, NJ - EIR, 483, WARNING LETTERS 06/01/2017 -
05/31/2018
BIOCON PHARMACEUTICALS, BANGALORE, INDIA - 483 04/23/2018 -
05/03/2018
K151168
SBA ONCASPAR (PEGASPARGASE)
BAYER PHARMA AG EIR
FOIA LOG EXCEL 04/30/2018 - 05/07/2018
SPREADSHEET DMF
JBS SOUDERTON INC MOPAC, SOUDERTON, PA - EIR, 483, ETC
09/13/2011 - 05/05/2018
BIOCON, BENGALURU, INDIA - 483 04/23/2018 - 05/02/2018
K170960
KATHLEEN CROSBY, BEVERLY CHERNAIK, ANN SIMONEAU 06/01/2017 -
09/28/2018
BIOCONF, BANGALORE, INDIA - 483 LAST SIXTY DAYS
NDA 203340
BLACKDUCK COOP AG SERVICES, BLACKDUCK, MN - INSPECTION RECS
05/01/2017 - 05/02/2018
GLYPHOSATE - CONGRESSIONAL CORR LAST 3 YRS
ASTRAZENECA AB, SODERTALJE, SWEDEN 4/18/08, 3/28/14 AMINO
GMBH, FRELLSTEDT, GERMANY 11/13/05 - 483S
INSYS THERAPEUTICS SUBSYS RECS 01/01/2014 - 01/01/2018
ZIMMER BIOMET HOLDINGS, INC - EIR, 483, ETC 04/01/2018 -
05/02/2018
VELTASS, PATIROMER AERS
PREMEETING BRIEFING RECS, POST MEETING SUMMARIES BAKUL PATEL,
APPLE, INC 05/01/2014 - 05/02/2018
PREVIOUSLY RELEASED 483 01/01/2015 - 05/02/2018
HA RIDER & SONS, WATSONVILLE, CA - DATES OF INSPECTIONS, 483,
RESPONSE, RFR ETC 05/02/2013 - 05/02/2018
ORANGE BOOK LISTINGS 01/01/1994 - 12/31/2016
EMD MILLIPORE CORP, BILLERICA, MA - EIR 04/01/2015 -
04/30/2018
BIOCON LTD, BANGALORE, INDIA - 483 04/25/2018 - 05/02/2018
K082327
AARTI DRUGS TARAPUR - 483 11/01/2017 - 01/08/2018
HUMAN CELL AND TISSUE ESTABLISHMENT REGISTRATION DATABASE
ENTRIES
NUVARING DR REDDY'S COMPLETE RESPONSE LETTER 01/01/2018 -
05/08/2018
RACHEL YANKAMA, MD, BATTLE CREEK, MI - INVESTIGATION RECS
01/01/2014 - 07/18/2016
K021012 FIRST PARTY
DIXIE DEW PRODUCTS, INC, ERLANGER, KY - CORR, EMAILS ETC NOT
PREVIOUSLY RELEASED 03/01/2017 - 05/04/2018
FCN 1582
FAP 2288, FDA-2014-F-1509
UNIVERSITY OF OKLAHOMA HEALTH SCIENCE CENTER, OKLAHOMA CITY, OK
- EIR 01/01/2007 - 12/31/2007
FDA EMPLOYEE CONTACT LIST 01/01/1990 - 12/21/2017
UNIVAR, LOS ANGELES, CA - EIR 04/01/2015 - 04/30/2018
AZIYO BIOLOGICS, RICHMOND, CA - EIR 01/01/2016 - 05/02/2018
DETAILED MEDICAL DEVICE REPORTS BREAST IMPLANT ASSOCIATED
ANAPLASTIC LARGE CELL LYMPHOMA 11/01/2006 - 05/02/2018
LIFEHEALTH LLC, ROSEVILLE, MN - EIR 05/08/2017-05/22/2017
MEMO TO FILE FROM DPS
LOBA FEINCHCEMIE GMBH, AUSTRIA - EIR 04/01/2015 - 04/30/2018

INDIVIDUAL RECS
COCONUT WATER IMPORTS IMPORT REPORT 01/01/2016 - 04/30/2018

RECS RE PRESENCE OF FLUORESCENT NANOPARTICLES IN COCA-COLA AND
PEPSI PRODUCTS
FCN 924
Impossible Foods Inc. GRAS 737
RECS RE VITAMIN U 01/01/1940 - 12/31/1969
RECS RE ETHICS WAIVERS 01/01/2017 - 05/01/2018
ABRAHAM KANATE, WEST VIRGINIA UNIVERSITY CANCER INSTITUTE,
MORGANTOWN, WV - 483 03/01/2018 - 05/03/2018
AMERICAN CRYOSTEM CORPORATION, MONMOUTH JUNCTION, NJ -
INSPECTION RECS 07/17/2017 - 07/26/2017
INTERAGENCY WORKGROUP RE CLEAN MEAT RECS 01/01/2010 - PRESENT

JOHNSON & JOHNSON CONSUMER, SKILLMAN, NJ - EIR, 483, CORR
3/10/14
UCSF RADIOPHARMACEUTICAL, SAN FRANCISCO, CA - EIR, 483, CORR
11/5/15
JOHNSON MATTHEW DBA JONAHSON MATTHEY PHARM MATERIALS,
CONSHOHOCKEN, PA - EIR, 483, CORR 3/29/12
CONCORD BIOSCIENCES, CONCORD, NH - EIR, 483, CORR 9/23/16
WUXI MEDICAL INSTRUMENT FACTORY, WUXI CITY, CHINA - 483
03/06/2017 - 03/10/2017
TEVA PHARMACEUTICALS USA, GREENBORO, NC - EIR, 483, CORR
7/18/13
PATRICIA L NORRIS, MD, PORTLAND, OR - EIR, 483, CORR 2/10/17

GPC MEDICAL LMITED, NEW DELHI, INDIA - 483 06/19/2017 -
06/22/2017
REQUESTS ORPHAN DESIGNATION STATUS FOR FOR DIAZEPAM 01/01/2012
- 06/30/2016
SAFIRSTEIN, BETH, MD, HALLANDALE, FL - EIR, 483, CORR 5/22/09

JIANGMEN NOWADAYS DAILY GOODS CO, LTD, CHINA - 483 03/06/2017 -
03/09/2017
AMNEAL PHARMACEUTICALS, BRANCHBURG, NJ - EIR, 483, CORR
10/16/15
MERCK SHARP & DOHME CORP, NORTH WALES, PA - EIR, 483, CORR
4/12/16
GRIFOLS BIOMAT USA, RICMOND, VA - EIR, 483, CORR 9/21/12
CHARLES RIVER LABORATORIES ASHLAND, OH - EIR, 483, CORR 4/8/15

ELITECHGROUP, BOTHEL, WA - EIR, 483, CORR 11/23/15
GRIFOLS DBA TALECRIS PLASMA RESOURCES, LAKEWOOD, CO - EIR, 483,
CORR 11/17/13
DELTA LABORATORIES PTY LTD, AUSTRALIA - 483 03/27/2017 -
03/31/2017
BAXALTA, THOUSAND OAKS, CA - EIR, 483, CORR 2/28/14
NDA 017010
3M COMPANY HEALTH CARE BUSINESS, SAINT PAUL, MN - EIR, 483,
CORR 5/14/15
KAVO DENTAL INVESTIGATION RECS 05/01/2007 - 05/03/2018
HHSF223200930006G
WINE FOREST, NAPA, CA - EIR 04/11/2018 - 04/11/2018
DESI MERATRAN, ALERTONIC
Spreadsheet of 483s issued in April 2018
LAURA & JOHN ARNOLD FOUNDATION - CORR
INDIVIDUAL RECS 2/1/18 TO PRESENT
INVESTIGATIONS IN SANJUAN, MAYAGUEZ, CAGUAS, ANASCO PR
AETHLON MEDICAL AND FDA - CALENDAR DATES, CORR RE EAP REQUEST
FOR HEMOPURIFIER
DOLE, SPRINGFIELD, OH - LISTERIOSIS OUTBREAK INVESTIGATION
DOLE, SPRINGFIELD, OH - LISTERIOSIS OUTBREAK INVESTIGATION 6/15
TO PRESENT
FDA EMPLOYEES, CONSULTANTS, FELLOWS ETC 42 U.S.C. 209(f) OR
209(g) 10/01/2015 - PRESENT
ANDA 088131, 088133, 088134 and 088135
RECS RE STATE OF HAWAII ABAWD TIME LIMIT WAIVER
Mackey, AC, ODS Postmarketing Safety Review, lansoprazole

(Prevacid), esomeprazole (Nexium), and interstitial nephritis.
RECS RE INVOKANA AMPUTATION RISK
503(B) GUIDANCE WATER FOR INJECTION ON SHORTAGE LIST
01/01/2015 - 05/03/2018
AKORN, DECATUR, IL SOMERSET, NJ AMITYVILLE, NY - 483
12/01/2017 - 12/31/2017
LALLEMAND HEALTH SOLUTIONS - EIR 01/01/2015 - 01/01/2018
K160684
JCB LABORATORIES, WICHITA, KS - 503-B Outsourcing Facility
Product Reports
BIG HEART PET BRANDS, BLOOMBSBURG, PA - 482, EIR, LAB REPORTS
02/01/2018 - 05/05/2018
K063202
Records related to Scott Street Tomato House with regards to
Foreign Supplier Verification Program - Importer List
RECS MEDICAGO INC RE INFLUENZA VACCINE
Chanelle Manufacturing Facility, Ireland - EIR MOST CURRENT
HANGZHOU CHEMICAL, CHINA - EIR 04/01/2015 - 04/30/2018
BLA 761046
US SMOKELESS TOBACCO CO (USSTC) - STN SE009713 WITHDRAWN
SUBSTANTIAL EQUIVALENCE RPTS
ZHEJIANG EXCEL PHARMACEUTICAL CO, LTD, CHINA - 483 04/01/2015
- 04/30/2018
LIJIANG YINGUA BIOCHEMICAL AND PHARMA CO LTD, CHINA - 483
10/16/2017 - 10/20/2017
BOND PHARMACY INC, CLINTON, MS - EIR 01/01/2015 - 05/06/2018

PHARMACYLCLICS XCYTRIN
K083752
PHARMACYCLYCS XCYTRIN 01/01/1990 - 12/01/2008
FDA-1986-P-0052
Complete response letter regarding the Biologics Licensing
Application (BLA) for proposed biosimilar rituximab by
manufacturer Sandoz (a Novartis Division)
Complete response letter regarding Biologics Licensing
Application (BLA) for proposed trastuzumab biosimilar by
manufacturer Pfizer
ANDA 072577
LITECURE, LLC, NEWARK, DE - EIR 05/01/2013 - 06/01/2013
OSUKA PHARMACEUTICAL CO - ABILIFY NDA 21-436 PICTURES,
DRAWINGS, DESCRIPTIONS
SBA for Lyrica CR NDA 209501
RITUXIMAB BLA CELLTRION CRL
DIETARY SUPPLEMENT AERS 07/01/2017 - 02/28/2018
TRASTUZUMAB CELLTRION BLA CRL
INAD 011-932
BIOTEST PHARMACEUTICAL, BOCA RATON, FL - EIR 3/3/16
AKORN, DECATUR, IL - 483 03/01/2018 - 05/07/2018
Threshold of Regulation (TOR) No. 2017-00
MASSBIOLOGICS, BOSTON, MA - EIR, 483 02/01/2017 - 05/31/2017
COMPLETE LIST STOCK DEFICIENCIES IN CDRH 510K SMART TEMPLATE

2017-2347
FAERS 4852112, 4840980, 4822735, ETC
AKORN, DECATUR, IL - 483 01/01/2018 - 07/01/2018
MEDICAL REVIEWS NDA 019763, NDA 018869, NDA 019661, ETC

K140284
ANDA 040062
AKORN, DECATUR, IL - EIR 04/15/2013 - 05/03/2013
AKORN, LAKE FOREST, IL - EIR 03/01/2017 - 04/01/2017
LIST OF INSPECTIONS 21 CFR PART 111 01/01/2006 - 01/31/2018
NADA 139-191
ANADA 200-248
2017-8065
NDA 011721
IND 016278
MEDSPA, SALON360 - RECS SENT TO STATE OF MICHIGAN DEPARTMENT OF
LICENSING AND REGULATORY AFFAIRS BUREAU OF PROFESSIONAL
LICENSING AND DRUG MONITORING
RECS PROVIDED TO STATE OF MICHIGAN DEPARTMENT OF LICENSING AND
REGULATORY AFFAIRS BUREAU OF PROFESSIONAL LICENSING AND DRUG
MONITORING
GLAXO KLINE SMITH SHINGRIX STUDIES 12/01/2003 - 05/10/2018
PREVIOUSLY RELEASED 483, EIR, RESPONSE 03/30/2018 - 05/01/2018
JBS MOPAC, ELIZABETHVILLE, PA JBS SOUDERTON INC, SOUDERTON, PA
- EIR: 01/01/2017 - 12/31/2017
IND 16130
GRAHAM FARMS, MOORE HAVEN, FL - INSPECTION RECS 05/01/2009 -
01/15/2015
NORTHWESTERN UNIVERSITY INSTITUTIONAL REVIEW BOARD EXHIBIT 14
08/06/2008 - 08/14/2008
Letter of Import Authorization to the German Regulatory Health

Authority (BfArM), dated on or around 12/22/2017, for Magnevist
(NDA 019-596) and Magnevist Pharmacy Bulk Package (NDA 021-037)
HOSPIRA, ROCKY MOUNT, NC AJINOMOTO NORTH AMERICA INC, RALEIGH,
NC, ETC 483 11/10/2004 - 02/02/2018
NDA 011721
ASSEMBLERS, CHICAGO, IL TURANO BAKING, BOLINGBROOK, IL ETC 483
11/16/2016 - 11/08/2017
PHYSIO-CONTROL, REDMOND, WA ETC 483 08/29/2016 - 12/15/2017
KATAYAMA SEIYAKUSYO CO LTD, JAPAN CONVATEC, UK ETC 483
EX-LAX INC, HUMACAO, PR ETC 483 12/14/2004 - 01/26/2018
PRODUCTOS QUIMICOS MONTERREY SA DE CV LERDO DE TEJADA EIR
04/01/2015 - 04/30/2018
ANDA 040011
ANDA 040036
ALABAMA ORCHID, MEMPHIS ORCHID EIR 01/01/2015 - 01/01/2018
NDA 19-658 SN0000
ANDA 040001
Review of BLA 12554/S-048, S-049, S-050, S-051, S-052, S-061,
S-062, S-064, S-065, S-066
PEACE RIVER CITRUS PRODUCTS INC, BARTOW, FL ETC 483 06/13/2016
- 02/20/2018
K854404
ANDA 206857
K142596 K161667
K122158
TITANIUM HIP TOOL K051032, TITANIUM HIP TOOL LOCKING PLATE
K072175, HIP TOOL IMPLANT K022139, ETC
YERVOY (IPILIMUMAB) - AERS
EPIPEN, EPIPEN JR - FAILURES 1/12 TO PRESENT
New strategic plan for recalls
AMERICAN FAMILY EXPO RECEIPT 01/01/2018 - 05/01/2018
AMERICAN DENTAL SLEEP MEDICINE IP, WEXFORD PA ETC - 483
03/16/2017 - 01/18/2018
AKRON, SOMERSET, NJ VERNON HILLS, IL - 483 01/01/2018 TO
PRESENT
INTERNATIONAL LABS - CLOPIDOGREL, PRAVASTATIN RECALL RECS,
SANCTIONS, AERS, ETC
FCN 1742, FCN 1845
NADA 100-237
NADA 140-971
COPY OF COMPLAINT TO GOOGLE
K173861
NDA 050450
MR TANGO ENTERPRISES, HIALEAH, FL CIVIL MONEY PENALTY RECS

08/01/2016 - 12/31/2017 FDA-2017-H-6798 CRD Docket No. T-18-612
NADA 200-352
NADA 200-007
List of all approved Exporting Unapproved Class III devices and

Class II Devices under Section 802 ii) List of all approved
Exporting Unapproved Class III devices and Class II Devices
under Section 801(e)(2) ETC
EPIC PRODUCTS LLC - CONSUMER COMPLAINT, INVESTIGATORY RECS ETC
04/28/2011 - 05/08/2018
Historical monthly versions of Electronic Orange Book Data
Files (
REGISTERED FIRMS E-CIGARETTE DEVICES, E-LIQUIDS 08/08/2016 -
05/07/2018
RECS RE ENTRIES OF WHEAT GLUTEN BENEO-ORAFTI SA
RECS RE ACETAMINOPHEN BETWEEN FDA AND BAYER 01/01/2010 -
03/29/2014
LIST OF 483S INCLUDING CITATION DESCRIPTIONS 01/01/2013 -
05/08/2018
GRN 744
NDA 019436 LABELING
NDA 019183 CARAFATE (SUCRALFATE) 1GM/10MLSUSPENSION ORAL NDA
209501 LYRICA CR (PREGABALIN) 82.5mg,165mg,330mg Tablets NDA
210192 Juluca
DEN160019
K030837
POPPIES INTERNATIONAL - RECALL RECS, MEMOS, RPTS, ETC
INDIVIDUAL RECS
FDA Letter to request label changes, the label itself, another
other letters concerning the drug company MYLAN, and the cancer
drug CAPECITABINE during this time period
SUPPL-17 NDA 022023
SUPPL-18 NDA 022023
All documents or information consulted, used, or relied upon

in setting the new RACC for cocoa powder at 5 grams in 21 CFR
101.12, going into effect on July 26, 2018 for manufacturers
with $10 million or more in annual sales.
NDA 011366
AKORN INC, SOMERSET, NJ - 483 03/01/2018 - 05/10/2018
APTINYX, EVANSTON, IL - EIR 03/01/2016 - 07/01/2016
KAYLIGHT CORP - MVCELLS AUTOLOGOUS PLATELET PREPARATION KIT
BK080057
RECS RE KYMRIAH - EMAILS, CORR, SCHEDULES 01/20/2017 -
05/11/2018
ESTAR TECHNOLOGIES LTD - TROPOCELLS AUTOLOGOUS PLATELET
PREPARATION KIT BK110035
ZELTIQ AESTHETICS INC - ZELTIQ COOLSCULPTING SYS K171069
RECS PREVIOUSLY RELEASED RE OHR PHARMACEUTICALS, GENAERA,
SQUALAMINE 05/01/2000 - 05/10/2018
ZELTIQ AESTHETICS INC - ZELTIQ COOLSCULPTING SYS K151179
GRAS 744
NARMS retail meats data Excel file with the added
Establishment Code field
NASCOBAL RECS
TESTOPEL ANDA 80-911 - AERS
DRAFT GUIDANCE SPECIAL PROTOCOL ASSESSMENT GUIDANCE FOR
INDUSTRY
WELLNESS CENTER PHARMACY - HORMONE REPLACEMENT DRUG APRVL LTRS,
AERS, STUDIES, ETC
DAPTACEL FLBA SUPPLEMENT 103666/5158 CLNCL RVWS
ROTA TEQ - INGREDIENTS INPLACEBO USED IN CLNCL TRIALS
OLIVIA'S ORGANIC SALAD MIX - INVESTIGATIONS 5/16
ALARIS SYRINGE PUMP MODEL 8100 - MDRS, DVC MALFUNCTION
PATHEON PHARMACEUTICALS INC, CINCINNATI, OH - EIR 2/5-14/18
MIDAZOLAM - ISRS 10516022, 1123496, 1136290, ETC

BIOCON, BANGALORE, INDIA - 483S 1/18 TO PRESENT
ANDA 206726 AERS
ARTERIOCYTE DBA COMPASS BIOMEDICAL, HOPKINTON, MA - INSPECTION
RECS 10/27/2017 - 11/10/2017
500 count label of Chlorzoxazone tablets 375 mg & 750 mg
manufactured by Mikart Inc
CORTROPHIN ZINC NDA 9-854, PRUIFIED CORTROPHIN GEL NDA 8-975
LBLG
DERBY PARADISE INC - ENTRY NUMBER BNI005666412
LOS ROBLES HOSPITAL, THOUSAND OAKS, CA - FORM 2579 9/10 TO
12/10
OKA/MERCK - ZOSTAVAX INSPS, IND, POST-MARKET CLNCL TRIALS, ETC

ASBESTOS IN TALC - MEMORANDUM OF TELEPHONE CONVERSATION 3/8/76,
3/9-11/76
DENIAL OF PHILLIPPE DOUILLET PETITION DKT1983-0404 LTR TO FDA
7/86 - FDA SURVEILLANCE ACTIVITIES
PCAS FINLAND OY, TURKU, FINLAND - EIR, 483 9/11/07 TO 5/11/18

LIST OF INSPS PURSUANT TO THE PRESCRIPTION DRUG MARKETING ACT
(PDMA) 2013 TO PRESENT
CORR BETWEEN MIN DISTRICT OFFICE AND OMDRHO AND DR SCOTT
AUGUSTINE, J RANDALL BENHAM, AUGUSTINE BIOMEDICAL ETC
MEDICAL USE OF MARIJUANA - RECS
ENEM NOSTRUM REMEDIED PVT LTD, MUMBAI, INDIA GALENDTIC PHARMA,
GANDHIDHAM, INDIA - 483 01/01/2018 - 02/28/2018
Documents showing the earliest date of publication of the FDAs

September 2001 Cumulative Supplement 9 to the Approved Drug
Products with Therapeutic Equivalence Evaluations, 21st Ed. in
hard copy form etc
K943508
Whole Device Listing and/or Device Registration Information
Manufacturer Registation #: 9610828
MARS PETCARE US INC, COLUMBUS, OH - EIR, 483, 482 01/01/2017 -
05/09/2018
Drugs@FDA "SubmissionStatusDate" field.
BIOCON, BANGALORE, INDIA - 483 APRIL 2018
ANDA 089685
A list of U.S. patents that have been listed in the Orange Book
INDIVIDUAL RECS 11/12/2017 - 05/08/2018
MEDTRONIC CRYOCATH LP, POINTE-CLAIRE, CANADA - 483 12/01/2009 -
10/31/2016
Biological Testing Procedures for Fluoride Dentifrices.
I am requesting a listing of the FDA New Molecular Entity (NDA

and BLA) approvals from 2006 to present (y/e 2017 inclusive)
for which the FDAs approval represents the first regulatory
agency approval in the world for that molecule or biologic
MARK GLAZEBROOK, HALIFAX, CANADA JACK BARKIN, NORTH YORK,
CANADA - 483 04/01/2010 - 08/01/2014
3M CANADA, BROCKVILLE, CANADA THORNHILL RESEARCH INC, TORONTO,
CANADA ETC - 483 03/01/2015 - 02/28/201
GLOBAL MED INC, TRENTON, CANADA ABBOTT POINT OF CARE, CANADA
ETC - 483 09/01/2013 - 08/01/2014
MEDPACE BIOANALYTICAL LABORATORIES LLC, CINCINNATI, OH PATHEON
PHARMACEUTICALS INC, CINCINNATI, OH - 483 05/01/2017 -
02/14/2018
THE NATURAL DOG COMPANY INC WINDSOR, CO TESTING RECS
01/01/2015 - 08/01/2015
PQ SILICA UK LTD, WARRINGTON, UK EIR
Ingredients for FDA-approved kinesiology tapes called Stark
Tape and Ares Tape.
K142541
AKORN, PAONTA SAHIB, INDIA - 483 02/01/2018 - 05/10/2018
COMMUNICATIONS BETWEEN FDA AND MIMEDX GROUP INC RE RFD FOR
AMNIOFIX INJECTABLE ETC 05/10/2000 - 05/10/2018
2017-4680
LEGACY PHARMACEUTICAL PACKAGING, EARTH CITY, MO - EIR
05/22/2017 - 05/26/2017
CORR BETWEEN CDRH OSB, OC, ODE AND DR SCOTT AUGUSTINE, J
RANDALL BENHAM, ETC
FOI DAILY LOG 4/30/18-5/4/18
FOI DAILY LOG 4/30/18-5/4/18
FOI DAILY LOG 4/30/18-5/4/18
FOI DAILY LOG 4/30/18-5/4/18
FOI DAILY LOG 4/30/18-5/4/18
FOI DAILY LOG 4/30/18-5/4/18
ANDA 206691
IDX LLC - DEN180001
Copies of the following AERS Reports associated with Case ID
6543134
NORTHWEST FARM FOOD COOPERATIVE, BURLINGTON, WA - TESTING RECS
05/01/2015 - 05/17/2018
PADE Reports for Lantus
ANDA 205973
NDA 18956
sNDA 22-307/S001
ADB INTERESTS LLC, HOUSTON, TX - EIR 10/01/2018 - 10/31/2017

AUROBINDO PHARMA, BACHUPALLY, INDIA - 483 03/11/2018 -
03/16/2018
YEARLY MEDICAL DEVICES ESTABLISHMENT REGISTRATION AND DEVICE
LISTING DATA 01/01/1999 - 05/01/2018
Lantus Dear Healthcare Provider letters, drug safety
communications
The FDA "ever-approved" list of all drugs approved from 1938-
present
RECS RE IMPORTATION OF INJECTION DRUGS 12/20/2017 - 05/09/2018

TESTING RECS 769949611431 ETC
GADOLINIUM CONTRAST AGENT RECS 01/01/1970 - 01/01/2018
ATORVASTATIN AERS
AURONEXT PHARMA LTD, INDIA - 483 03/01/2018 - 03/06/2018
RA-FDACDRH-238-17 Reasonable accommodation determination
letter
NDA 006799
ANDA 075079
TESTING RECS Bravo Blend Chicken diet for dogs & cats - Chub
Item # 21 - 102 UPC 829546211028
MEDTRONIC XOMED, INC, MYSTIC, CT - EIR 10/01/2015 - 11/30/2015

INDIVIDUAL RECS
Levonorgestrel Intrauterine System AERS
FDA CORR WITH SEN ISAKSON 01/01/2013 - 05/10/2018
Any and all information related to pediatric studies and
miralax
K022950
I would like a copy of the drug oversight board meeting notes
from 2009 where the FDA talked about miralax/peg 3350
mprolium Residue Methods for Cattle Tissue and Poultry Tissue.
NDA 208264 SBA

Records, laboratory results regarding FDA Sample Number
1019038.
Form 483 issued by FDA to Vista Pharmaceutical Ltd unit in
Nalgonda District, Telangana, India
BOEHRINGER INGELHEIM FREMONT INC, FREMONT, CA 4/4/17
ULTRAGENYX PHARMACEUTICAL INC, NOVATO, CA 6/20/17 BIOMARIN
PHARMACEUTICAL INC, NOVATO, CA 12/14/17 - 483S
COVALENT LABORATORIES PVT LTD, MEDAK DISTRICT, INDIA - EIR

4/10/15 PHARBIL ARZNEIMITTEL GMBH, GOTTINGEN, GERMANY - 483
7/10/15 NIPRO PHARMA CORP, IWASE GUN, JAPAN - 483 12/15/17
2012-1522 3/1/12 2012-1402 2/28/12 2012-1336 2/24/12
2012-408 1/23/12 TO 2/21/12 2012-315 1/18/12 TO 2/15/12 2012-
903 2/10/12 TO 3/12/12
FRESENIUS KABI ONCOLOGY LIMITED BADDI, INDIA - INSPECTION RECS

EEOC RVWS 1/2014 TO PRESENT
HYBRISONIC SHEATH K983985, SCANTEC PAD K031894 TROPHON2
K173865, ETC
ABILIFY - AER
FOIA LOG SINCE 2/2018
ULTRAGENYX PHARMACEUTICAL, INC., NOVATO, CA ETC - 483
OL CORR LOG 2017-2011
MEDISCA INC - FROM 2657, NDC NUMBERS, NOTICES OF
DISCONTINUANCE, ETC 1/03 TO 12/31/10
AKORN, DECATUR, IL - 483 05/02/2017 - 05/09/2018
AKORN, DECATUR, IL - 483 03/01/2018 - 05/10/2018
MEDICAL DEVICE RECALL DATA 10/01/1999 - 05/01/2018
NDA 003402 NDA 204485 ETC
K012736
CHEMISTRY REPORT PLAVIX, ZYPREXA
K141718 K162207
COMMUNICATIONS RE NEVRO CORP, SENZA SYSTEM
MENTHA AND ALLIED PRIVATE LTD, RAMPUR, INDIA - 483, WARNING
LETTER 08/01/2017 - 12/02/2017
CRISABOROLE MEDICAL REVIEWS, CMC REVIEWS
CORR TO, FROM OPDP OR DDMAC RE ADVERTISING, PROMOTIONAL
LABELING
FOIA LOG ABBOTT LABORATORIES 4/01/2018 to 04/30/2018
COMMUNICATIONS BETWEEN DR MICHAEL VERDOLIN OF PAIN CONSULTANTS
OF SAN DIEGO AND CDRH RE NEVRO SENZA SPINAL CORD
STIMULATION7/1/17 TO 12/31/17
RECS RE CA209026
ASTRAL STERITECH, INDIA - 483 03/01/2018 - 05/01/2018
K031786
K063692
EMPIRE CLINICAL RESEARCH, MIAMI LAKES, FL - INSPECTION RECS
02/01/2017 - 05/10/2018
NDA 209310
K100821
RECS RE REMOVAL OF NDC 51927153300
AFATINIB ORPHAN DESIGNATION RECS
ANDA 204521 NDA 017473
LILLY DEL CARIBE INC, CAROLINA, PR - 483 07/10/2017 -
07/21/2017
PDF copies of the monthly Orange Book supplements
TOMITA PHARMACEUTICAL CO LTD, JAPAN - 483 03/01/2018 -
03/31/2018
K001852
BOEHRINGER INGELHEIM, FREMONT, CA - EIR 03/01/2017 - 05/01/2017

RECS RE BOXED WARNING ATYPICAL ANTIPSYCHOTICS
Analytical worksheets for Sample 965880 and Sample 965881

K902924 K934340 K011169 FIRST PARTY
NDA 018239 ANDA 074382 ANDA 073636 ETC
CPM MEDICAL CONSULTANTS, LLC, RICHARDSON, TX - INSPECTION RECS
4/18/18
BIORELIANCE CORPORATION, ROCKVILLE, MD - 482, 483, EIR ETC
10/12/2014 - 04/17/2018
WUXI APPTEC INC, ST PAUL, MN - EIR 3/26/2018 - 03/30/2018
BIOTEST PHARMACEUTICALS CORPORATION, BOCA RATON, FL - 483
02/01/2018 - 05/14/2018
NDA 018342
FAERS individual case report for case number 3708449
SYNOVIS MICRO COMPANIES ALLIANCE, INC, BIRMINGHAM, AL - EIR
01/01/2018 - 01/31/2018
EVANGER'S DOG AND CAT FOOD, WHEELING, IL- EIR 01/01/2017 -
05/11/2018
COVALENT LABORATORIES PVT LTD, MEDAK DISTRICT, INDIA PHARBIL
AZNEIMITTAL GMBH, GOTTINGEN, GERMANY NIPRO PHARMA CORP, IWASE
GUN, JAPAN - 483
SOLU-CORTEF (HYDROCORTISONE SODIUM SUCCINATE) AER 3/18 TO
PRESENT
PATHEON PHARMACEUTICALS, CINCINNATI, OH - 483, EIR 02/14/2018 -
03/31/2018
HARMONY CONCEPS, ODGEN, UT - RECS RE RECALL RAW MEAL, EIR, 483
ETC 01/01/2011 - 05/16/2018
HISAMITSU PHARMACEUTICAL CO, INC, TOSU, JAPAN - 483 09/01/2017
- 09/30/2017
ROHTO PHARMACEUTICAL COMPANY LTD, JAPAN - 483 02/01/2018 -
03/31/2018
HALYARD HEALTH, INC., ALPHARETTA, GA EIR
AERS 10516022, 11234396, 11234397, ETC

ROMAINE LETTUCE OUTBREAK INVESTIGATION, LINE LIST, TESTING ETC
09/01/2017 - 05/14/2018
ISOTRETINOIN DATA
ORION CORPORATION, FINLAND ETC - 483 07/28/2014 - 04/21/2017
AUROBINDO PHARMA AURONEXT, INDIA - 483 02/01/2018 - 03/31/2018

ANDA 200166
K140190
DOUGLAS CAMPBELL, MELISSA GARCIA - CV 05/14/2018 - 05/14/2018

FOIA LOG EXCEL 05/07/2018 - 05/21/2018
UNAPPROVED PRODUCT
RECS RE IMPORT ALERT 66-41
K162078
K171135
FRESENIUS KABI ONCOLOGY LIMITED, BADDI, INDIA ETC 04/14/2016 -
10/31/2017
DIETARY SUPPLEMENT INSPECTION RECS 01/01/2017 - 09/30/2017
DOUGLAS CAMPBELL 483 05/02/2014 - 05/14/2018
MR SATHEESH THOMAS 483 01/01/2008 - 05/14/2018
2017-710 2017-1327 2017-1583 ETC
UNITED SAFETY AGENT 04/15/2018 - 05/15/2018 FSVP RECS
ANDA 208181
2017-6239 2017-6240 2017-7278 ETC
SANDOZ GMBH, AUSTRIA ETC 483 09/13/2017 - 03/16/2018
2017-73 2017-74 2017-75 ETC
MELISSA GARCIA 483 01/01/2013 - 05/14/2018
NDA 012750
TOPCO ASSOCIATES, LCC FSVP RECS 11/01/2017 - 05/01/2018
AMNEAL PHARMACEUTICALS, BROOKHAVEN, NY - EIR, 483, ETC
01/01/2016 - 05/15/2018
AMNEAL PHARMACEUTICALS, HAUPPAUGE, N Y - EIR, 483, ETC
01/01/2016 - 05/15/2018
DAUNORUBICIN HYDROCHLORIDE INJECTION SOLUTION - RLD LABELS
K152948
ANDA 077555
ANDA 208825 ANDA 209718 ANDA 208785
BERKSHIRE STERILE MANUFACTURING, LEE, MA - 483, EIR 03/01/2018
- 05/31/2018
K172258
K172258
FOIA daily log from 3/15/18- 5/15/18
Lantus Recall # D-029-2
HOSPIRA HEALTHCARE INDIA PVT INDIA - 483 4/3/2018
NDA 19082
GARAMYCIN, GENTAMICIN INTRATHECAL INJECTION - APPROVAL RECS
01/01/1980 - 01/01/1990
ANDA 206857
RECS RE INTUITIVE SURGICAL
FDA CORR WITH EUROPHARMA RE CURAMIN
K153293
COOPERVISION INC, WEST HENRIETTA, NY - INSPECTION 4/11/18
BELMA COMPANY, MOROCCO - EIR, 483 01/01/2010 - 05/15/2018
K162172 K131305 K150861
AMNEAL PHARMACEUTICALS, BRANCHBURG, NJ - EIR, 483, WARNING
LETTERS ETC 01/01/2016 - 05/15/2018
DEN170015
RECS RE GAVESTINEL Gavestinel (GV-150526 GV-150526A CAS Nos.
153436-22-7 and 153436-38-5)
AMNEAL PHARMACEUTICALS, PISCATAWAY, NJ - EIR, 483, WARNING
LETTERS ETC 01/01/2016 - 05/15/2018
LIST OF PETITIONS 01/01/2017 - 12/31/2017
AMNEAL PHARMACEUTICALS, INDIA - EIR, 483, WARNING LETTERS ETC
01/01/2016 - 05/15/2018
DR REDDY'S LABORATORIES LTD, ANDHRA PRADESH, INDIA - NOTICES,
483S, INJUNCTIONS, ETC 1/07 TO PRESENT
DIFFERIN GEL - ISRS 14313339, 13877092, 13402100, ETC
RECS RE TIRF-REMS PROGRAM 12/01/2012 - 05/15/2018
GLENMARK PHARMACEUTICALS INC USA - MUPIROCIN TOPICAL CREAM ANDA
201-587 SBA
PRESCRIBERS, PHARMACISTS, ETC TIFR-REMS 01/01/2012 - 05/15/2018

INDIVIDUAL RECS
DAEWOONG, NABOTA - FMD 145 05/01/2018 - 05/16/2018
PRODUCT QUEST MFG, LLC, DAYTONA BEACH, FL - EIR, 483, CORR
10/02/2017 - 10/06/2017
VITAL LABORATORIES PRIVATE LIMITED, INDIA - 483 04/03/2017 -
04/06/2017
K880038
ANDA 091001
TELEMED, LITHUANIA 483 8/3/17
PROSANA DISTRIBUCIONES, MEXICO - 483 03/06/2017 - 03/09/2017

LUPIN LIMITED, GOA, INDIA - 483 03/27/2017 - 04/07/2017
NIH CLINICAL CENTER, BETHESDA, MD - EIR, 483, CORR 2/11/15
QUVA PHARMA, TEMPLE, TX - EIR, 483, CORR 6/20/14
DEN170073
ATL DISTRICT OFFICE 483 04/01/2018 - 04/30/2018
BLT DISTRICT OFFICE 483 04/01/2018 - 04/30/2018
OHM LABORATORIES, NORTH BRUNSWICK, NJ - EIR, 483, CORR 3/18/14
K KRISTENE GUGLIUZZA, GALVESTON, TX - EIR, 483, CORR 5/16/16

ANDA 074190
INTERNATIONAL MEDSURG CONNECTION, SCHAUMBURG, IL - EIR, 483,
CORR 11/22/17
MYERSON, CHICAGO, IL - EIR, 483, CORR 5/16/17
US VASCULAR LLC, BEAVERTON, OR - EIR, 483, CORR 4/24/17
MINDRAY DS USA, DBA MINDRAY NORTH AMERICAN, MAHWAH, NJ - EIR,
483, CORR 3/31/16
RAM SCIENTIFIC, NASHVILLE, TN - EIR, 483, CORR 7/29/16
MEDICAL REVIEW, CHEMISTRY REVIEW EUCRISA UNREDACTED
NDA 208843 (SIKLOS)
COMMUNICATIONS BETWEEN FDA AND MYLAN, FDA AND HEALTH CANADA RE
EPIPEN SHORTAGE 01/01/2018 - 05/16/2018
COMMUNICATIONS BETWEEN FDA AND TEVA RE FREMANEZUMAB
RECS RE TESTING OF FOOD SAMPLES FOR RESIDUES OF GLYPHOSATE AND
OTHER HERBICIDES 01/01/2016 - 12/31/2017
MEDIVET BIOLOGICS, NICOLASVILLE, KY - 483, WARNING LETTER
01/01/2008 - 01/10/2018
NCT03058666 RECS
PRUGEN PHARMS - K082089
INDIVIDUAL RECS
AMERICAN LABORATORIES INC, OMAHA, NE - EIRS 11/1517-12/15/17
OXYGEN DEVELOPMENT LLC, PALM SPRINGS, FL - EIR EXHIBITS 11-17

RISPERAL - AERS, RECS
EVA HEURICH, ORLANDO, FL - EIR 09/01/2016 - 10/01/2016
APRIL 483 CHICAGO DISTRICT
APRIL 483 DENVER DISTRICT
APRIL 483 DALLAS DISTRICT
FRESENIUS KABI, INDIA - INSPECTION RECS 11/20/2008,
11/20/2009, 08/28/2012, ETC
APRIL 483 CINCINNATI DISTRICT
APRIL 483 LOS ANGELES DISTRICT
APRIL 483 NEW JERSEY DISTRICT
APRIL 483 KANSAS CITY DISTRICT
K170918
APRIL 483 DETROIT DISTRICT
APRIL 483 FLORIDA DISTRICT
APRIL 483 MINNEAPOLIS DISTRICT
APRIL 483 NEW ENGLAND DISTRICT
APRIL 483 NEW ORLEANS DISTRICT
MODULIGHT INC, FINLAND - EIR, RESPONSE, WARNING LETTERS
01/02/2012 - 01/01/2018
APRIL 483 NEW YORK DISTRICT
APRIL 483 PHILADELPHIA DISTRICT
APRIL 483 SAN FRANCISCO DISTRICT
APRIL 483 SEATTLE DISTRICT
EX0000210
SE0006178
Eclipse NEX Order Review Records
SE0006177
GPC Silver 100s Box Review Records
GPC Silver Box Review Records
NDA 207920
Kamel Red Smooth Taste Box Review Records
NDI 962
CRAIG CURTIS, ORLANDO, FL - EIR 09/15/2017 - 09/30/2017
COMPASS RESEARCH, ORLANDO, FL - EIR 10/01/2017 - 10/10/2017
INDIVIDUAL RECS
CAP 8C0312
483 CDRH INTERNATIONAL OPERATIONS 04/01/2018 - 04/30/2018
AUROBINDO PHARMA LTD, UNIT X11, BACHUPALLY, INDIA - 483
03/01/2018 - 03/31/2018
NDA 020629 ANDA 061212 ANDA 201587 ETC
April 2018
Fresenius Kabi, West Bengal, India INSPECTION RECS
NDA 020429
INSULIN AERS
NORTHWESTERN UNIVERSITY IRB, CHICAGO, IL - INSPECTION RECS
07/14/2008 - 08/11/2008
NADA 129-831
VITA-HERB NUTRICEUTICALS, PLACENTIA, CA - EIR 05/20/2015 -
05/18/2018
NADA 035-805
Individual Case Reports

INDIVIDUAL RECS 10/01/2017 - 05/17/2018
SYNTHO PHARMACEUTICALS, FARMINGDALE, NY - EIR, 483, CORR
8/26/16
KESHAVA PVT, LTD MAHAHRASHTRA, INDIA - 483 05/25/2017 -
05/31/2017
WHPM, IRWINDALE, CA - INSPECTION RECS 10/30/2012 - 11/16/2014

ICU M EDICAL, LAKE FOREST, IL - EIR, 483, CORR 5/27/15
GODDARD, DR JAMES K, ST PAUL, MN - EIR, 483, CORR 5/14/15
ASTRAZENECA PHARMACEUTICALS, COPPELL, TX - EIR, 483, CORR
3/29/16
ALEXION PHARMACEUTICALS, NEW HAVEN, CT - EIR, 483, CORR
4/19/17
FDA-ORA-18-1012807
K151650 K991513 K131249 ETC
Product Report (Form 3801) under 21 CFR 1002.10 for the
following companies: Skylit Medical AND Luma Light
System
EMERGENT BIODEFENSE OPERATIONS LANSING, CANTON, MA - EIR, 483,
CORR 12/21/17
CHARLES RIVER LABORATORIES PATHOLOGY ASSOCIATES, DURHAM, NC -
EIR, 483, CORR 3/7/13
MONSANTA INC - CIVIL ACTIONS
K172448
BRACCO DIAGNOSTICS, MONROE TOWNSHIP, NJ - EIR, 483, CORR
6/5/17
Product Report under 21 CFR 1002.10 for: Daavlin.
TG UNITED, BROOKSVILLE, FL - EIR, 483, CORR 1/25/17
ADELLO BIOLOGICS, CHICAGO, IL - EIR, 483, CORR 1/26/18
ABIOMED, IMPELLA - RECS 1/1/10 TO PRESENT
K170359 K150522 K082924 ETC
HIZENTRA - MARKETING APRVL AND EXCLUSIVITY RECS
ELOS MEDTECH PINOL, DENMARK EIR NOV 2013
All documents and communications on the 3 inquiries received by

FDA from prospective generic applicants related to obtaining
the necessary samples of the reference listed drug Zavesca to
conduct bioequivalence studies as discussed in "Reference
Listed
NARCAN, NALOXONE DATA
RECS RE ALLEGED DATA INTEGRITY AKORN
ANDA 075467
K910091
FSVP RECS
NUPLAZID FAERS 04/29/2016 - 05/18/2018
COMMUNICATIONS BETWEEN FDA AND PHARMEDIUM, AMERISOURCE BERGEN
RE 503B OUTSOURCING FACILITIES IN MS, NJ, TX, TN 01/01/2016 -
05/18/2018
Approval Review Packages
NDA 208399
7177746 7178912 7181846 ETC
7233748 7235474 7236982 ETC

LETTER FROM HEALTH CANADA TO FDA RE FOLIC ACID FORTIFICATION
12/28/1990 - 12/29/1996
INDIVIDUAL RECS
Phase I, II, and III trials for Lymerix, the patent
application, and all vaccine victim stories
LIST OF TEMPORARY PERMITS CANNED TUNA DRAINED WEIGHT 05/01/2017
- 05/18/2018
7258418 7261121 7266439 ETC
6109797 6126073 6199556 ETC
6451906 6537999 6537999 ETC

Application by Ipsum LLC seeking approval of the Ipsum medical
device for the treatment of hepatocellular carcinoma under the
Expedited Access Pathway Program
NDA Submission for Pulmozyme (Dornase Alpha) Sponsor: Genetech

Edwards Lifesciences LLC Sapien MAUDE RECS
6732465 6783213 6790214 ETC
6942380 6945685 6953167 ETC

Annual Drug Establishment Registration Status information
7063794 7067984 7103379 ETC

CORR WITH REP ROD BLUM 01/01/2015 - 05/21/2018
PMA for medical device Glycosorb AB0 by applicant Glycorex
Transplantation AB
NDA 050108
ANDA 062158
SCHWEBEL BAKING COMPANY INC, YOUNGSTOWN, OH - 483 03/20/2018 -
04/05/2018
PRODUCT CODE DATA DEVICES, HCT/P S
PATHEON PHARMACEUTICALS INC, CINCINNATI, OH - EIR 02/05/2018 -
02/14/2018
K173692
SIEMENS HEALTHCARE DIAGNOSTICS, INC, EAST WALPOLE, MA ETC - 483
04/12/2016 - 03/26/2018
ARANESP EFFICACY DATA
RESPONSE TO CITIZEN PETITION 00P-1213 filed for CALCITONIN-
SALMON 100 IU/ML-1ML VIALS
JAZZ PHARMACEUTICALS PLC, ETC - CORR WITH FDA RE REMS PROGRAM
FOR XYREM ETC 01/01/2007 - 05/21/2018
Product approval documentation and any subsequent supplements
relating to applications for Testosterone Solution
RECS RE A RNA SEQUENCING ASSOCIATED WITH THE 2016 HEPATITIS A
OUTBREAK ASSOCIATED WITH SCALLOPS
14138616 14187292 14044047 ETC
EMAILS BETWEEN DR GONCALO GAMBA DA COSTA AND EMPLOYEES OF
INTERNATIONAL LIFE SCIENCES INSTITUTE RE BISPHENOL A ETC
01/01/2015 - 05/20/2018
NDA 021945 ANDA 200271
CELL SURGICAL NETWORK, CALIFORNIA STEM CELL TREATMENT CENTER

ETC - WARNING, UNTITLE LETTERS 01/01/2017 - 05/21/2018
7315557 7317565 7317886 ETC
7339120 7344120 7345472 ETC

FOREIGN FOOD FACILITIES SPREADHSEET
7366034 7367046 7367048 ETC
7402719 7409111 7412686 ETC
7431999 7432744 7436086 ETC
7502235 7502305 7511369 ETC
7542404 7549690 7551399 ETC

ANDA 061212 SBA
GOJO INDUSTRIES, INC, CUYAHOGA FALLS, OH - EIR 05/01/2017 -
07/03/2017
NDA 210563
NIVOLUMAB, PEMBROLIZUMAB, ETC AERS
7274768 7276861 7277360 ETC

483, RESPONSE, EIR RELEASED 11/30/2017 - 01/01/2018
LAMICTAL (LAMOTRIGINE) LBLG
PLANMED CLARITY K163328
ZILRETTA NDA 08-845
SDI LTD - RIVER STAR TOOTH DESENSITISER K172047
INDIVIDUAL RECS
INDIVIDUAL RECS
MONAT HAIR CARE - CAERS 8/29/17 TO 3/27/18
SENZA SPINAL CORD STIMULATION SYSTEM CONSUMER COMPLAINTS JULY 1
TO DEC 21 2017
NDA 203510
Invokana Amputation Information
483 RELEASED 12/01/2017 - 12/31/2017
AMNEAL PHARMACEUTICALS, EAST HANOVER, NJ - EIR, 483, CORR ETC
01/01/2016 - 05/22/2018
AMNEAL PHARMACEUTICALS, PATERSON, NJ - EIR, 483, CORR ETC
01/01/2016 - 05/22/2018
AMNEAL PHARMACEUTICALS, COMMACK, NY - EIR, 483, CORR ETC
01/01/2016 - 05/22/2018
CONSUMER COMPLAINT REF #27717
K843758 K843755
K843756 K843754
K932363 K843753
K932364 K932369
Summary Basis of Approval for Gleolan
RECS RE POLITICAL APPOINTEES RE MICHAEL COHEN ETC
EIR RELEASED 12/01/2017 - 12/31/2017
K031099
ALCON LABORATORIES, INC, SINKING SPRING, PA - EIR 02/20/2018 -
02/23/2018
PFIZER, IRELAND - 483 01/01/2014 - 12/31/2014
K932368 K932366
Nalge Nunc, Rochester, NY EIR 04/2013
K843532
K932367
The award and modifications of Task Order TO HHSM500T0003 under
HHSF223200850014I
PDUFA LIST
New Molecular Entity New Drug Applications (NME NDAs) list
in .csv format
483, EIR, RESPONSE RELEASED DECEMBER 2017
K112127
SGS CANADA INC, ONTARIO, CANADA - INSPECTION RECS 05/22/2013 -
05/22/2018
Please provide the Biologics License Applications (BLAs) list
in .csv format
NEVRO CORP, SENZA SPINAL CORD STIMULATION DEVICES TRADE
COMPLAINTS 7/1/17 TO 12/21/17
CSL PLASMA INC, CHATTAGNOOGA, TN - EIR 12/01/2017 - 12/31/2017

TORCHED ILLUSIONS, BEAVERTON AND TIGARD, OR - TESTING RESULTS,
INSPECTION RECS
APOKYN LABELING
MANHATTAN DRUG COMPANY, HILLSIDE, NJ - EIR 05/03/2016 -
05/01/2018
AMNEAL PHARMACEUTICALS, INDIA - EIR, 483, WARNING LETTERS ETC
01/01/2016 - 05/22/2018
AVANTI NUTRITIONAL LABORATORIES, MIAMI LAKES, FL - EIR
01/01/2017 - 05/22/2018
RECS RE COMPLAINT 11/01/2017 - 01/31/2018
K041995
BREAKTHROUGH THERAPY DESIGNATION TAFAMIDIS
BLA 761064
Lonza AG Drug Product Services, Hochbergerstrasse 60A, CH-4057

Basel, Switzerland - Inspection Recs 05/22/2013 - 05/22/2018
Prior approval Packages from original NDAs
Complete Response Letter for filgrastim by Adello
PERSONAL RECS
OHR PHARMACEUTICALS, GENAERA PHARMACEUTICALS, INC FORM 3454 ETC
01/01/2000 - 05/23/2018
K123907
K173035
ANDA 61621
K843757 K843760
T2Candida de novo application and related documentation
ALCON LABORATORIES, LAKE FOREST, CA - EIR 03/19/2018 -
03/19/2018
AERS AMNIOFIX, EPIFIX, AMNIOFIX INJECTABLE ETC
K946106 K063435
WARSAW BIOMET WARSAW, IN EIR 09/12/2016 - 04/24/2018
PIRAMEL, LEXINGTON, KY - EIR, 483 02/26/2018 - 03/14/2018
FRESENIUS SE & CO KGA CITIZEN PETITION 11/01/2017 - 05/22/2018

REGISTRATION RECS PANETE PRO-V FOAM SHEER HAIR CONDITIONER
Pantene Pro-V
HAMMILL MANUFACTURING COMPANY, MAUMEE, OH - EIR 01/01/2008 -
05/28/2009
COMPLAINT 149535
SPARK THERAPEUTICS INC, PHILADELPHIA, PA NEW HORIZON
NUTRACEUTICAL LLC, KENNETT SQUARE, PA DIVERSIFIED CHEMICAL
PRODUCTS, INC, WILMINGTON, DE - 483 01/26/2016 - 10/25/2017
CONGRESSIONAL COR LOGS REP DAVID SCHWEIKERT 01/01/2013 -
05/10/2018
KALEO COMPLAINT 04/01/2014 - 05/22/2018
K843759, K811818, K811817
FRESENIUS KABI RECS RE DATA INTEGRITY 10/01/2012 - 05/22/2018

CORR FROM PUBLIC RE NUPLAZID - COMPLAINTS, LETTERS, ETC
NDA 018485
Summary review for the sNDA approval of ipilimumab and

nivolumab as a treatment for patients with intermediate or poor
risk, previously untreated advanced renal cell carcinoma
CAMBREX PROFARMACO, ITALY - 483 05/19/2017
BLA 125409/S-118 SBA
BLA 125514/S-14/S-118 SBA
FRESENIUS MEDICAL CARE NORTH AMERICA TEXAS, IRVING, TX RAKESH

PATEL, HOUSTON, TX LOPEZ TORTILLA FOODS, INC, DALLAS, TX - 483
FRESENIUS KABI DEUTSCHLAND, GERMANY - 483 ETC 01/01/2018 -
05/21/2018
Results of the Domestic-Import India-Origin Solid Oral Generic

Dosage Forms and Control Samples Survey starting with tier 1
(fy2015), tier 2 (fy2016) and any additional tiers assigned.
ANDA 209687 ANDA 208785 ETC
PAXVAX INC - VIVOTIF VAERS 740374-1, CAUSE OF HOSPITALIZATION,
DIAGNOSIS, LAB TEST, ETC
TU-K INDUSTRIES INC, TU-K LABORATORIES INC, 2K INDUSTRIES - MS

KAY DIOXYGEN DEVELOPER RECALLS, CMPLNTS, INVESTIGATIONS, ETC
DAKIN DAIRY FARMS INC, MYAKKA CITY, FL - MILK TESTING RESULTS,
SHIPPING RECS 5/19/14 TO 1/2/18
TRIPLE T SPECIALTY MEATS INC, IA - MULTISTATE OUTBREAK OF
SALMONELLA TYPHIMURIUM LINKED TO CHICKEN SALAD
TRIPLE T SPECIALTY MEATS INC, IA - MEMOS, TESTING DATA, RPTS,
ETC PRIOR TO 1/30/18
SCOTT GOTTLIEB - ELECTRONIC COMMUNICATIONS THAT CONTAIN THE
TERMS BREITBART, INFOWARS, GATEWAY PUNDIT, ETC 1/20/17 TO
PRESENT
EDWARDS LIFE SCIENCES - PERIMOUNT MAGNA NITRAL EASE PERICARDIAL

BIOPROSTHESIS REPLACEMENT HEART VALVE MODEL NUMBER 7300TFX MDRS
K120412
RES-Q 1000 - IND, CORR
NDA 208780
BLA 125554/S-034 SBA
23 FDA-483 items regarding the WuXi Apptec Bio-pharmaceutical
Ltd. 2017-08-02
K142877
MYLAN PHARMACEUTICALS INC, MORGANTOWN, WV - EIR 03/09/2016 -
01/01/2017
GRASP Notice 2449
Comments on Docket FDA-2015-P-0569
SWISHER INTERNATIONAL, SOUTHERN CROSS TOBACCO COMPANY, INC ETC
RESPONSE TO WARNING LETTER 2/01/2016 - 05/23/2018
List of people/companies who submitted comments to Docket FDA-
2015-P-0569
K171560
K151123
DR HELENA YU, MD, MEMORIAL SLOAN KETTERING CANCER CENTER, NY,
NY - 483 0/06/2015 - 05/23/2018
EXCEL DATABASE TOTAL INSTALLED BASE FOR DIGITAL X-RAY SYSTEMS
BROKEN DOWN BY MANUFACTURER, MODEL, INSTALL DATE 01/01/2013 -
05/01/2018
BLISS SOFTWARE RECS
ASTRAZENECA, COPPELL, TX - 483 09/01/2017 - 01/31/2018
CATALENT PHARMA SOLUTIONS LLC, NORRISVILLE, NC - 483
05/19/2017
K173409 K133670
US STEM CELL INC AKA USRM, US STEM CELL CLINIC, US STEM CELL
ETC, SUNRISE, FL - CORR WITH FDA 05/24/2017 - 05/23/2018
FDA 2579 Planmeca, Model ProX Serial Number IPX017257
KROGERS, SCHNUCK'S DAIRY, PRAIRIE FARMS DAIRY, HAZELWOOD, MO -
INSPECTION RECS CERTIFIED 01/01/1975 - 12/31/1990
PFIZER HOSPIRA, MCPHERSON, KS - 483 01/01/2016 - 01/11/2018
Documents regarding nicotinamide riboside and/or nicotinamide

riboside mononucleotide new dietary ingredients
Orphan drug designation submission for BioCryst's BCX-7353
Orphan drug designation submission for Zogenix's ZX-008
MERGE HEALTHCARE INC, HARTLAND, WI - EIR WARNING LETTER
CLOSEOUT
K090801
EDWARDS LIFESCIENCES, IRVINE, CA - WARNING LETTER 03/01/2010 -
03/31/2010
AKORN PHARMACEUTICALS, DECATUR, IL - 483 ETC 01/01/2018 -
05/31/2018
ORCHID ORTHOPEDIC SOLUTIONS AKA ORCHID ARCADIA, ORCHID ANZON,
ARCADIA, CA - EIR 05/01/2013 - 07/31/2013
ORCHID ORTHOPEDIC SOLUTIONS AKA ORCHID ARCADIA, ORCHID ANZON,
ARCADIA, CA- EIR 11/01/2017 - 12/31/2017
K052871
NOBEL BIOCARE USA LLC, YORBA LINDA, CA - 483 04/19/2010 -
05/14/2010
FDA toxicology and chemistry reviews for FCN 1808 and FCN 1875
CFSAN meetings regarding nicotinamide riboside and/or
nicotinamide riboside mononucleotide in a food or dietary
supplement
Product Quest MFG. LLC CMS Case# 543233 RESPONSE TO WARNING
LETTER
K180146
K173489
ZIMMER BIOMET - RESPONSE TO 483 04/24/2018 - 05/24/2018
K160524
TEXAS MEDICAL CENTER, HOUSTON, TX - EIR 01/01/2007 -
05/01/2018
DEN180001, IDx-DR
DEN170073 ContaCT by Viz.AI
K&S FOOD CENTER LLC, HARTFORD, CT TAYLOR FARM, INC,
LONDONDERRY, VT STAY FRESH FOOD, LLC, MERIDAN, CT - 483
08/02/2016 - 10/24/2017
FCN 1858
REVIEWER'S NOTES K172510
2008-TFM-723-0256-P, 09-TFM-709-0257
INVISALIGN ADVERSE EVENTS 01/01/2010 - 05/25/2018
DALLAS CALCO INC, DALLAS, TX - EIR 01/01/2016 - 05/24/2018
FRESH HEMP FOODS LTD REFUSAL RECS 07/01/2010 - 07/31/2010
Request of RLD labels of West-Ward's Daunorubicin
Hydrochloride Injection NDA 050731
AKORN DATA INTEGRITY RECS 01/01/2016 - 05/24/2018
Monthly sales and distribution data of antimicrobial drugs
01/01/2009 - 05/24/2018
All AERS database entries for Nuplazid (pimavanserin) and
quetiapine
ANDA 75-969
List disciplinary actions against TIRF-REMS enrollees and
their names, actions, dates. List of possible TIRF-REMS
disciplinary actions, rules and protocols/policies.
ABBVIE LETTER RE NDA 021015/S-043 ETC
ANDA 200166
RECRO PHARMA CRL 01/02/2017 - 05/25/2018
Narrative summary of death cases reported on obeticholic acid

Zofran Approval package reviews and associated documents for
original NDA 020103 Suppl 004

K063158 K053342
DEAD SEA WORKS, ARAVA, ISRAEL - EIR 06/01/2015 - 09/30/2015
K050896, K152626, K091505
NDA 018651
VAERS ID: 740374-1
Roche, Palo Alto, CA EIR 08/2006
K030096
K130852
WYETH PHARMACEUTICALS INC - LODINE (ETODOLAC) NDA 18-922/S005
NOVARTIS PHARMACEUTICALS CORP - CATAFLAM (DICLOFENAC POTASSIUM)
SBA
IMPRIMIS PHARMACEUTICALS INC, IMPRIMIS RX CA - PEG 40 CASTOR
OIL AERS, 483S, NOTICES, ETC
2018-473 2018-477 2018-561 2018-812 2018-825 2018-1061 2018-
1304 2018-1354 2018-1387 2018-1389
EMAILS CONTAINING THE TERMS MUCKROCK, MUCKROCK.COM
DEBORAH J MILLER, CANCER PATIENT LIAISON EMAILS WITH DAVID
WEINSTEIN MD, BARBARA GOULD, KELLY GAHAN 01/01/2018 -
05/24/2018
EDWARDS LIFESCIENCES - EIRS 9/09, 11/09 EXHIBIT AR 4, JEM 20,
23, ETC
Lutrepulse (N19687) PADER RECS
VOMARIS INNOVATIONS INC - PROCELLERA K130350 ACRYMED INC -
ACRYMERM SILVER ANTIMICROBIAL WOUND DRESSING K002599
2017-8566
2018-3718
AMERICAN DENTAL AIRSONIC TECHNOLOGIES, CORPUS CHRISTIE, TX -
EIR, 483, CORR 11/8/17
CERNO PHARMACEUTICALS, MIAMI, FL- EIR, 483, CORR 11/17/17
11/13/2017 - 11/17/2017
SHANGHAI WEIERYA DAILY CHEMICALS FACTORY, CHINA - 483
04/10/2014 - 04/14/2017
ROCURONIUM BROMIDE INJ ANDA 91-115 LTR (CERTIFIED)
EMMETT F BRANIGAN, MD, BELLINGHAM, WA - EIR, 483, CORR
01/29/2018 - 01/31/2018
AUROBINDO PHARMA UNIT 4 EIR 05/01/2018 - 05/29/2018
NDA 204442 SBA
AESCULAP, INC, CENTER VALLEY, PA - EIR 05/01/2015 - 12/21/2017
BAXTER HEALTHCARE CORPORATION, DEERFIELD, IL QUALITY FISHERIES

DBA THE NIOTA FISH MARKET, NIOTA, IL MARS WRIGLEY
CONFECTIONARY, LLC, BURR RIDGE, IL ETC - 483 12/08/2009 -
01/26/2017
TAP PHARMACEUTICAL PRODUCTS INC, ABBOTT LABS, ABBVIE INC -
LUPRON DEPOT AERS, CORR, WARNINGS, ETC
LIVANOVA PLC, MUNICH, GERMANY - EIR, 483, ETC 01/01/2016 -
05/29/2018
REDBULL CAERS REPORTS
SATHEESH THOMAS 483 01/01/2015 - 05/24/2018
1% ISOSULFAN BLUE ANDA 90-874, ANDA 206-831 BIOEQV
LYMPHAZURIN 1% ISOSULFAN BLUE NDA 18-310, ANDA 90-874, ANDA
206-831 APRVL RECS
CR BARD INC, DAVOL INC - BARD 3DMAX MESH K081010 510K
SUBMISSIONS, CORR 1/1/08 TO PRESENT, ETC
FCN 39 FCN 366
CR BARD INC, DAVOL INC, SURGICAL SENSE INC - KUGEL HERNIA PATCH
K963141, CORR 1/1/96 TO PRESENT
FCN 316
NDA 020648
November 29, 2000 letter from Melinda K. Plaisier, Associate

Commissioner for Legislation, FDA, to The Honorable Thomas J.
Blilely, Jr. regarding medical device reprocessors
CR BARD INC, DAVOL INC - BARS 3DMAX MESH K081010 510K
SUBMISSIONS, CORR 1/1/08 TO PRESENT
GLENMARK PITHAMPUR, INDORE, INDIA - 483 05/01/2018 - 05/30/2018

DIO SPREADSHEET OF ATTEMPTS TO IMPORT SODIUM THIOPENTAL ETC
01/01/2010 - PRESENT
DAVOL INC, SURGICAL SENSE INC - KUGEL HERNIA PATCH K963141 CORR
1/1/96 TO PRESENT, ETC
NUTRITION GROUP PLC UK - 483
INN SBA
NDA 018471
SECUREPORTIV CATHETER SECUREMENT ADHESIVE K170505
NDA 020126
SUMIMOTO CHEMICALS, JAPAN - 483 07/01/2016 - 07/31/2016
CVM APPROVED ANALYTICAL TEST METHODS RE: 1. Sulfadimethoxine
and Ormetoprim 5:3 IN TYPE C POULTRY FEEDS 2. Sulfadimethoxine
and Ormetoprim 5:1 IN TYPE C FISH FEEDS
LIVANOVA PLC, ARVADA, CO - EIR, 483, ETC 01/01/2016 -
05/29/2018
GEN1700298 7/31/17
US SMOKELESS TOBACCO COMPANY LLC - SUBSTANTIAL EQUVALENCE RPTS
STN SE0014130, SE0014131, SE0014132
ANDA 209687 ANDA 208785 ETC
LIVANOVA PLC, HOUSTON, TX - EIR, 483, ETC 01/01/2016 -
05/29/2018
GENSTRIP REGISTRATION AND LISTING 01/01/2013 - 12/31/2014
Chemistry and Toxicology memos from FCN 1253
GLENMARK PHARMACEUTICALS, LTD, INDIA - 483 05/21/2018 -
05/24/2018
2018-1221 2018-1309 2018-1323 ETC
SHIONOGI & CO, JAPAN - 483 09/01/2016 - 09/30/2016
NDA 203567
NDA 202067 203993 ANDA 209687 208785 TENTATIVE APPROVAL
LETTERS
CORR FROM AMAZON TO FDA RE INSPECTIONS OF AMAZON FULFILLMENT
FACILITIES LEXINGTON, KY BREINIGSVILLE, PA, MIDDLETOWN, DE
2008 TO PRESENT
RECS RE WARNING LETTER DEPUY DUPONT ORTHOPAEDICS, WARSAW, IN
01/01/1990 - 01/01/2000
AUROBINDO PHARMA UNIT 16 483 03/01/2018 - 05/29/2018
Investigator's BrochureROEKO Activ Point Chlorhexidine Points

Brand: Coltene Medical Specialty TGP (Gutta percha containing
tetracycline or doxycycline) Gutta-percha device with a
therapeutic or pharmacological additive
NUPLAZID AERS
ADMA BIOLOGICS, BOCA RATON, FL - EIR, 483, CORR 8/14/14
CARVI, EL PASO, TX - EIR, 483, CORR 8/8/17
MIRAMAR LABS, SANTA CLARA, CA - EIR, 483, CORR 8/1/16
CSBIO, MENLO PARK, CA - EIR, 483 04/09/2018 - 05/03/2018
OKC ALLERGY SUPPLIES, OKLAHOMA CITY, OK - EIR, 483, CORR
4/26/13
RUWANTI GUNAWARDANE, MD, FULTON, MD - EIR, 483, CORR 5/16/16

MOHAMED ALI EL-SHAHAWY, LOS ANGELES, CA - EIR, 483, CORR
2/25/16
VERTICAL PHARMACEUTICALS, SAYREVILLE, NJ - EIR, 483, CORR
11/1/16
ISOMEDIX SERVICES, LIBERTYVILLE, IL - EIR, 483, CORR 1/8/14
WEINER, GILBERT R, MIAMI, FL - EIR, 483, CORR 9/6/16
MEDTRONIC SOFAMOR DANEK USA INC, MEMPHIS, TN - EIRS 4/27/16,
4/28/16. 5/3/17
HAEMONETICS PCS 300 PLASMA COLLECTION SYS BK180185
KARYOPHARM - 483S, RESPS 1/1/17 TO 3/31/17
PHARMAVITE NATURE MADE VITAMIN B W/C & FOLI ACID- CAERS
FCN 1761
US STEM CELL INC, SUNRISE, FL - INSP RECS
DEZHOU JINLUO MEAT PRODUCTS, LINYI MEISHAN TIANXING BIOLOGICAL

PRODUCTS CO LTD, MEISHAN SHENYANG WANBANG TIANSHENG
BIOTECHNOLOGY CO LTD, SHENYAN, ETC - EIRS, 483S 6/16
INDIVIDUAL RECS
KERRY, INC - GRAS NOTICE ALPHA-GALACTOSIDEASE
CHLORAPREP REPORTS OF ADVERSE REACTIONS
WUXI APPTEC BIO-PHARMACEUTICAL LTD - RESPONSE TO 483 08/01/2017
- 05/01/2018
LIST OF REGISTERED FOOD FACILITIES 01/01/2010 - 05/30/2018
K943470 K943728 FIRST PARTY
K151422
BURPEE MATERIALS TECHNOLOGY LLC, EATONTOWN, NJ - 483 01/30/2018
- 03/14/2018
RECS RELIED ON RE CHOKEBERRY JUICE USED TO PREPARE A COLOR
ADDITIVE
FDA sample analysis reports for: 991-0235242-6 991-0235452-1

LUITPOLD PHARMACEUTICALS, SHIRLEY, NY - 483 03/19/2018 -
04/11/2018
DIPHENMYDRAMINE, CHLORAPHENIRAMINE AERS
LIST OF FSVP IMPORTERS THAT HAVE BEEN IDENTIFIED AT ENTRY
DRAGON HEART MEDICAL INC, ADDISON, IL - 483 04/03/2018 -
04/24/2018
BIOSYNERGY INC, ELK GROVE, IL - 483 12/19/2017 - 01/25/2018
FLAWLESS BEAUTY LLC, OCEAN, NJ - 483 11/20/2017 - 01/10/2018

MBI DISTRIBUTING INC, DBA MBI NUTRACEUTICALS, LINDON, UT - 483
11/15/2017 - 01/12/2018
MUSCULOSKELETAL TRANSPLANT FOUNDATION INC, EDISON, NJ - 483
11/14/2017 - 01/18/2018
PFIZER PHARMACEUTICALS, INC, PR - 483 01/10/2018 - 01/26/2018

MAUDE 1220908-2017-02461, MDR Report Key 6944128
K162891 K173571
RARITAN PHARMACEUTICALS, EAST BRUNSWICK, NJ - 483 12/05/2017 -
01/08/2018
Analytical test methods for tulathromycin marker residues in
the following animal tissues: CP-60,300 in liver of cattle and
CP-60,300 in kidney of swine.
SOVEREIGN PHARMACEUTICALS LLC, FT WORTH, TX - 483 01/08/2018 -
01/12/2018
BIOTE MEDICAL, IRVING, TX - 483 03/19/2018 - 04/23/2018
PFIZER - VANCOMYCIN EIRS 1/1/15, WARNING LTRS, VIOLATION
NOTICES, ETC
GLENMARK PHARMACEUTICALS LIMITED, INDIA - 483 05/10/2018 -
05/25/2018
INTERNATIONAL MEDICAL INDUSTRIES INC, POMPANO BEACH, FL - 483
03/14/2018 - 04/03/2018
BLA 125320 BLA 125320
FDA comments in response to USTR-2018-0005 " Request for Public

Comment Concerning Proposed Determination of Action Pursuant to
Section 301: China's Acts, Policies, and Practices Related to
Technology Transfer, Intellectual Property, and Innovation"
BOSTON SCIENTIFIC, MAPLE GROVE, MN - 483 04/10/2017 -
04/30/2017
ABBOTT LABS, NORTH CHICAGO., IL, 9/8/93, 7/23/97 ABBOTT LABS,
ABBOTT PARK, IL 6/13/03, 10/5/05 - INSP RECS
ANIMAL STUDIES PICHIA PASTORIS RE FAP 2207 21 CFR 573.750
DERBY PARADISE INC - ENTRY NUMBER BNI00572642 NOTICES FOR
REQUEST OF INFORMATION, BILLS OF LADING, WORKSHEETS, ETC
Date Range: 12/21/2015 - 10/21/2016 Qualitative and
Quantitative composition from dossier section 3.2.P.1 of the
drug product approved with NDA 208645
CENEXI, FRANCE - 483 12/11/2012 - 05/31/2018
CELLTRION, INCHEON, KOREA - 482 04/01/2018 - 05/31/2018
FDA approval of tolvaptan for ADPKD with trade name Jynarque

NDA 022341 S27
NDA 202158
NDA 011601 RLDs Primary Display Panel
K171056
K172723
GRANULES INDIA LIMITED MICRO LABS LIMITED, IND-SWIFT
LABORATORIES LIMITED, INDIA - 483 03/01/2018 - 03/31/2018
K161110
ENTRY NUMBER D97-0907978-1 - FDA NOTICE OF ACTION, LAB RPTS,
ETC
CENTER FOR FOOD SAFETY AND APPLIED NUTRITION - EMAILS FOR
INDIVIDUAL S WHO HANDLE STANDARD OF IDENTITY MATTERS
BENZNIDAZOLE - RECS 1/1/12 TO PRESENT
TEVA - ANDA 90-141 FINAL APRVL LTR
ABBVIE BIOTECHNOLOGY LTD, BARCELONETA, PR - EIRS, 483S 4/28/17
PFIZER PHARMACEUTICALS LLC, VEGA BAJA, PR - EIR, 483 1/26/18

MYLAN LLC, CAGUAS, PR - EIR, 483 10/24/16
COMMUNICATIONS BETWEEN FDA AND GOOD CLEAN LOVE, INC, EUGENE, OR
RE MEDICAL CLAIMS 01/01/2015 - 12/31/2017
NDA 019854 NDA 019853 NDA N019030 ETC SBA
JANSSEN ORTHO LLC, GURABO, PR - EIRS, 483S
FENWAL INTERNATIONAL INC, MARICAO, PR - EIRS, 483S
AMGEN MANUFACTURING LTD, JUNCOS, PR - EIRS, 483S
NADA 91-467
DKT 2001D-0219
DKT 1976F-0392
DKT 2012S-1178-0035 DKT 2017S-0023
DKT 2006P-0002
DKT 1996P-0511, DKT 1976P-0400
MONAT HAIR CARE PRODUCTS AERS 3/27/18 TO 5/31/18
K021344
NEUTRAL POSTURE CHAIRS APPROVAL RECS
GRAS petitions 6GO312 and 6G0311
ANDA 204144
FDA Form 2579 for multiple diagnostic x-ray systems at Martin
Army Community Hospital, FT Benning GA
Labels and Labeling (package insert/patient information) for
Dasatinib (Manufactured by Apotex Inc.)
WELCHDRY, INC, HOLLAND, MI - EIR 06/01/2016 - 12/31/2017
NDA 022141
NDA 209269
VICTORIAN CHEMICAL CO PTY LTD FAP 2A4340
K030009
K040215
K121720
OHM PHARMA INC, MINERAL WELLS, TX - 483 11/30/2012 - 05/31/2018

HHSF223201610024B HHSF22316001 ETC
2018-21
CASE ID12615760
ALEXANDRA BALAGUTA CORR WITH QUINCY BIOSCIENCE, MADISON, WI
06/01/2010 - 06/01/2018
FOIA LOG 02/13/2018 - 06/04/2018
NDA 020547
ANDA73458 ANDA75209
NDA-19-472, Motilium (domperidone)
RALEY'S FSVP RECS 02/01/2018 - 05/31/2018
FOIA LOGS MAY 2018
OHM PHARMA, INC, MINERAL WELLS, TX - EIR 11/30/2012 -
05/31/2018
COMM BETWEEN FDA AND RECRO PHARMACEUTICALS RE APPROVAL IV
MELOXICAM 01/01/2017 - 06/01/2018
LIST OF INSPECTIONS, CITATIONS 06/01/2017 - 06/01/2018
NOVACYL, THAILAND - 483, RESPONSE 03/19/2018 - 05/19/2018
483, RESPONSE, EIR RELEASED 4/30/18 - 06/01/2018
EMAILS BETWEEN CFSAN AND FLAVOR AND EXTRACT MANUFACTURERS,
COMMUNICATIONS FROM FEMA RE GRAS 06/01/2018 - 06/30/2018
PIRAMAL PHARMA SOLUTIONS INC, LEXINGTON, KY APACE KY LLC,
FOUNTAIN RUN, KY ETC 483 11/16/2015 - 09/07/2017
LYONDELL CHEMICAL COMPANY, HOUSTON, TX - EIR 04/01/2015 -
05/31/2018
PREVIOUSLY RELEASED 483, 483 RESPONSE, EIR MAY 2018
LOG OF CLOSED REQUESTS FOR 483S MAY 2018
RECS RE TRESOR RARE, MIAMI FL - MEDWATCH REPORTS, INSPECTION
RECS 01/01/2018 - 01/07/2018
AMCOL HEALTH & BEAUTY SOLUTIONS EIR 10/01/2016 - 06/01/2018
PACIFIC OLEO PLO, TIMUR EIR 04/01/2015 - 05/31/2018
PENTA MANUFACTURING COMPANY, LIVINGSTON, NJ - EIR 04/01/2015 -
05/31/2018
SPEECH BY LARRY G KESSLER 10/04/2000 FDA and the Reuse of
Single Use Devices: Policy Now Established"
LIST OF INSPECTIONS MAY 2018
K170755
ONYX PHARMACEUTICALS, INC, SOUTH SAN FRANCISCO, ETC - 483
01/06/2012 - 02/28/2017
DR FARID MARQUEZ, HIALEAH, FL - EIR 09/08/2014 - 06/01/2018
PRODUCTOS QUIMICOS, NUEVO LEON EIR 04/01/2015 - 05/31/2018
AMGEN INC, THOUSAND OAKS, CA BAXALTA INC, LOS ANGELES, CA -
483 06/20/2016 - 03/16/2018
RECS RE CBE-30 FOR CHANGE IN API SUPPLIER
BLA 125387/S23
1) Transcripts from Pharmacy Compounding Advisory Committee,

October 27-28, 2015 2) Pre-meeting reports and data related to
domperidone at the Pharmacy Compounding Advisory Committee,
October 27-28, 2015
NDA 21748 NDA 21574 ETC
MEDTRONIC INC, NORTHRIDGE, CA - 483 02/14/2018 - 03/14/2018
ANDA 209373
HERBALAND NATURALS INC, RICHMOND, BC, CANADA - EIR 06/03/2016
- 06/04/2018
CAPE FEAR NATURALS, WILMINGTON, NC ETC - 483 07/29/2009 -
06/14/2017
PARKER LABORATORIES INC, FAIRFIELD, NJ - 483 01/30/2018 -
03/20/2018
ENTRY RECS
NDA 017871
DMF SPREADSHEET
MYLAN PHARMACEUTICALS INC, MORGANTOWNN, WV - 483 03/19/2018 -
04/12/2018
LILLY DEL CARIBE, PR - 483 7-21-2017
FOIA LOG 02/24/2018 - 06/06/2018
CLOSED FOIA REQUESTS 04/25/2018 - 06/06/2018
MIMDX TISSUE SERVICES LLC 483 RESPONSE, FINAL CLASSIFICATION,
CORR ETC 01/01/2016 - 06/06/2018
OAKWOOD LABORATORIES LLC, SOLON, OH - 483 03/05/2018 -
03/29/2018
DIAMOND WIPES INTERNATIONAL, INC, CHINO, CA ETC - 483
10/26/2010 - 10/13/2016
RECS RE SAMPLES #966498 ETC
XTTRIUM LABORATORIES INC, MOUNT PROSPECT, IL - 483 11/14/2017 -
03/15/2018
SUN PHARMACEUTICAL INDUSTRIES INC, CRANBURY, NJ - 483
02/13/2018 - 03/09/2018
RENAISSANCE LAKEWOOD LLC, LAKEWOOD, NJ - 483 02/22/2018 -
03/15/2018
K173317
Biological Investigational New Drug (BB-IND) application for
Tanezumab
QA LABORATORIES INC, KANSAS CITY, KS - 483 03/22/2018 -
04/19/2018
PURE SOURCE, DORAL, FL- 483 02/08/2018 - 03/01/2018
K081635
K063785
Food Contamination for Walmart Store East, LP, Store # 4332

Case # 4-2950-16-120 8990 Turkey Lake RD Orlando Florida
ALBERTSONS TOLLESON - SUPER VALU (AZ) ETC FSVP RECS
OBETICHOLIC ACID, OCALIVA AERS
SYNTHON ARGENTINA, SA, ARGENTINA CATALENT BELGIUM - 483
02/18/2009 - 11/25/2016
COMM LAURIE LENKEL RE MARC ULLMAN ESQ, ETC 08/22/2017 -
06/04/2018
UCKELE HEALTH & NUTRITION, INC, BLISSFIELD, MI - 483
09/12/2017 - 09/22/2017
NDA 018873
K173405
Records related to the 2013 quarantine of hydroxyzine HCl
shipped to KVK Tech, Inc.
TECHNICHEM, ANAHEIM, CA - 483 02/07/2018 - 03/09/2018
DAEWOONG PHARMACEUTICAL CO LTD, SOUTH KOREA - 483 11/08/2017 -
11/20/2017
4 HEALTH GRAIN-FREE PUPPY FORMULA DOG FOOD - CMPLNT
INNOVATIVE STERILIZATION TECHNOLOGIES LLC, DAYTON, OH - EIRS
8/13/15, 11/4/15
CELEBREX, MELOXICAM, SYNTHROID, ETC - RECS
LETAIRIS (AMBRISENTAN) NDA 22-081SBA, RISK EVALUATION AND
MITIGATION STRATEGY (REMS) RELATED INQUIRY LTRS,
ACKNOWLEDGEMENT LTRS, ETC
VALEANT PHARMACEUTICLAS NORTH AMERICA, ROCHESTER, NY - 483,
EIR, CORR 9/1/16
AMAROS CO LTD, KOREA - 483 05/08/2017 - 05/12/2017
DRAXXIN ENVIRONMENTAL ASSESSMENT, FONSI
NUVASIVE, MEMPHIS, TN - 483, EIR, CORR 5/4/17
DR REDDY'S LABORATORIES, SHREVEPORT, LA - 483, EIR, CORR
10/10/15
RTI SURGICAL INC, ALACHUA, FL - 483, WARNING LETTER 04/01/2017
- 11/10/2017
K111010
JOHNSON LABORATORIES, TROY, AL - EIR, 483, CORR 3/30/17
LIMACTAL, VITAMIND, FISH OILS, ETC - RECS
RECS RE DISCONTINUATION OF DRUGS AS NME AND NEW THERAPEUTIC
BIOLOGICAL PRODUCTS 01/01/1970 - 05/31/2018
TEVA PARENTERAL MEDICINES, IRVINE, CA - EIR, 483, CORR 7/29/16

GENVOYA, ROYATAZ - RECS
RECS RE REPORT REQUIRED BY 21 U.S.C. 2223(a)(3) RECS RE
PUBLIC INPUT MEETINGS ETC
IMPRIMIS PHARMACEUTICALS INC, IMPRIMIS RX CA - AERS, 483S,
RECALLS, ETC
CERTIFICATE OF PHARMACEUTICAL PRODUCTS CERTIFIED
MERCK & CO, NORTH WALES, PA - EIR, 483, CORR 9/20/18
SEINDNI CO LTD, KOREA - 483 05/25/2017 - 05/26/2017
K063204
4D-R100.CAG-cohREP1 for treatment of choroideremia from 4D
Molecular Therapeutics ORPHAN DESIGNATION RECS
K042037 K082446
483 issued in April 2017 to Analytical Food Laboratories in
Grand Prairie, Texas 04/01/2017 - 04/30/2017
RECKITT BENCKISER, MECHANICSBURG, PA - 483, EIR, CORR 8/17/17

GENESIS BIOSYSTEMS, LEWISVILLE, TX - 483, EIR, CORR 8/31/17
FOREST RESEARCH INSTITUTE, JERSEY CITY, NJ - 483, EIR, CORR
3/18/16
DEXCOWIN CO LTD, SEOUL, KOREA - 483 08/28/2017 - 08/31/2017
EMAILS WITH TERM MUCKROCK, MUCK ROCK, MUCKROCK.COM 06/11/2014 -
06/05/2018
CORR RE TALCUM POWER, JOHNSON & JOHNSON, IMERYS TALC AMERICA
INC, WINDSOR MINERALS ETC 01/01/1983 - PRESENT
RECS RE EMAIL SYSTEM, SEARCH PROCEDURES
EXPAREL AERS
BANYAN MEDICAL, WARWICK, RI - 483, EIR, CORR 9/29/17
Add the Application Number (NDA/BLA) to the pediatric labeling
database
BOEHRINGER INGELHEIM PHARMACEUTICALS, RIDGEFIELD, CT - 483,
EIR, CORR 2/28/17
JULIO A PEGUERO, MD, HOUSTON, TX 483, EIR 04/03/2017 -
04/06/2017
BAXALTA US, THOUSAND OAKS, CA - 483, EIR, CORR 1/19/18
ASTRAZENECA PHARMACEUTICALS LP, FREDERICK MD - 01/23/2017 -
05/23/2017
CSL BEHRING, BRADLEY, IL - 483, EIR, CORR 7/19/17
LIST OF PROCESSING PLANTS FRUIT COMMODITIES, POTATOES, CORN,
LETTUCE 01/01/2013 - 06/05/2018
PIRAMEL PHARMA SOLUTIONS INC, LEXINGTON, KY - 483 02/26/2018 -
03/14/2018
EI LLC, KANNAPOLIS, NC - EIR 02/21/2014 - 02/26/2014
NDA 5382
CHIQUITA BRANDS INTL INC, SAN JOSE, COSTA RICA - 483 02/08/2016
- 08/11/2017 MEDTRONIC VASCULAR GALWAY, IRELAND - 483
02/12/2016
CORR FROM 2008 TO PRESENT BETWEEN AMAZON AND FDA RE FOOD

FACILITY REGISTRATION STATUS OF AMAZON FULFILLMENT LOCATIONS
IND 57004
CV's of all FDA workers for the following time frame:
01/01/2015-06/05/2018
CICLOPIROX STUDY RESULTS
IND 60688
LABCHEMS CORP, MAYAGUEZ, PR CARGILL FLAVOR SYSTEMS OF PUERTO
RICO, ARECIBO, PR - 01/04/2012 - 10/06/2016
LYMPHAZURIN, 1% ISOSULFAN BLUE NDA 18-310 %1 ISOSULFAN BLUE
ANDA 90-874 %1 ISOSULFAN ANDA 206-831
STELLARTECH RESEARCH CORP, MILPITAS, CA - EIRS
OFIRMEV (ACETAMINOPHEN INJ) NDA 22-450 - FORM 3542, STATEMENT
OF DISPUTE, ETC
ZIMMER BIOMET EIR, 483, WARNING LETTERS ETC 08/01/2017 -
01/31/2018
GELLAN GUM GELRITE MK DMF 14721
ENTRY RC9-0028038-4 - ANALYTICAL PACKAGE
ENTRY RC9-0027649-9 - ANALYTICAL PACKAGE
RC9-0027765-2 - ANALYTICAL PACKAGE
RC9-0027528-5 - ANALYTICAL PACKAGE
RD8-0022096-7 - ANALYTICAL PACKAGE
ENTRY RD8-0021952-2 - ANALYTICAL PACKAGE
RECONSERVE OF MICHIGAN, INC, BATTLE CREEK, MI EL BORINCANO
FEED MILLS INC, TOA ALTA, PR UNITED FEED CO-OP, OKEECHOBEE, FL
ETC - 483
DEN160003 BP060002 BP150262 etc
MYLAN, MORGANTOWN, WV - 483 01/01/2018 - 06/06/2018
FDA records obtained by Michigan Department of Attorney General

Licensing & Regulation Division in Investigative report
SUBMISSION OF NDA 01/01/2017 - 06/06/2018
PROMACTA AERS Promacta (eltrombopag).
MEDWATCH REPORT
ANDA 060657 LABELING
RECS RE DOLE FOOD COMPANY, INC, DOLE FRESH VEGETABLES, YUMA, AZ
- INSPECTIONS ETC 01/01/2008 - 06/06/2018
NDA 11751 ANDA 089804
FRESH EXPRESS, YUMA, AZ - INSPECTION RECS ETC 01/01/2008 -
06/06/2018
REFUSAL TO FILE LETTER ISSUED TO CELGENE CORPORATION OZANIMOD
02/01/2018 - 06/01/2018
K162762
K173417
DEAD SEA WORKS LTD, ARAVA, ISRAEL - EIR 06/01/2015 - 09/30/2015

Regulatory information and data for Flumist. - Clinical Review
- Statistical Review and Evaluation - Summary Basis for
Regulatory Action
INDIVIDUAL RECS
2017-1188
ROCKY MOUNTAIN POISON & DRUG CENTER, DENVER, CO - 483
02/23/2015 - 02/25/2015
INDIVIDUAL RECS
FENTANYL - INDIVIDUAL RECS
AMLION TOOTHPASTE MFG SDN, MALAYSIA - 483 2018
PURAC BIOQUIMICA, SA, SPAIN DR REDDY'S LABORATORIES, INDIA -
483 04/18/2016 - 03/09/2018
All records for any NDA with Hydrogen Peroxide as active
ingredient.
FAERS 14455349 14652359 14652365 ETC
CAERS - 2017-CFS-000632, 2017-CFS-001025, 2017-CFS-001106, ETC

ALMA LASERS LTD INJURIES ETC 01/01/2010 - 12/31/2015
RECS RE COMPLAINT
COUNTRYSIDE CREAMERY BUTTER - INVESTIGATION RECS
NDA 009388
K180265
CARNIVORE MEAT COMPANY LLC, GREEN BAY, WI - EIR, 483, ETC Date
Range: 05/01/2013 - 06/07/2018
BIO-PHARM, LEVITTOWN, PA - 483 01/01/2018-PRESENT
K151909, K161598, K152093
CSL BEHRING, BRADLEY, IL - EIR 07/11/2017 - 07/19/2017
GOLDEN PEANUT COMPNAY LLC - PECAN PORDUCTS INSPS, RECALLS,
APRVLS, ETC
ASTELLAS PHARMA US, NORTHBROOK, IL - EIR 8/21/17 TO 6/7/18
VAERS - INDIVIDUAL RECS
WELLBUTRIN - RECS FEDERAL NUTRITIONAL GUIDLINES
K850754
K9 NATURAL PET FOOD - RECALL RECS 4/18
BENADRYL - AERS 6/28/18-7/1/18
EIR PREVIOUSLY RELEASED 05/01/2018 - 05/31/2018
483S PREVIOUSLY RELEASED 05/01/2018 - 05/31/2018
INDIVIDUAL RECS
BRISTOL MYERS SQUIBB COMPNAY, OTSUKA PHARMACEUTICAL -
DEVELOPMENT AND COMMERCIALIZATION COLLABORATION 01/01/1980 -
01/12/2018
GE HEALTHCARE, GENERAL ELECTRIC COMPANY - WARNING LETTER RECS
09/27/2007
GILEAD SCIENCES, FOSTER CITY, CA - 483 01/06/2014 - 06/06/2018
TENEO INFERIOR VENA CAVA ETC 510K ETC 01/01/2008 - 12/31/2015

RECS RE UNITED SAFETY AGENTS, FSVP RECS
DEN160029
MERIDIAN MEDICAL TECHNOLOGIES, INC, BRENTWOOD, MO - RESPONSE TO
WL 09/20/2017 - 09/22/2017
UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH,
MADISON, WI ANI PHARMACEUTICALS, BAUDETTE, MN - 483
01/20/2015 - 07/28/2016
INDUSTRIAS QUIMICAS FALCON DE MEXICO INSPECTION RECS
K972382
RECS RE DISCOLORATION OF KVK TECH, INC HYDROXYZINE HCI ETC
REPORT OF INSPECTION FOR COMPLIANCE WITH 21 CFR 589.2000 and
589.2001
SYNTHES PRODUCTS, WEST CHESTER, PA - EIR 09/26/2017 -
10/31/2017
All Serious Cases (including deaths) reported to the FDA under
the Reaction Group "Eye Disorders" for the product "Eliquis" as
listed in the FAERS
P140003
RECS RE ALMA LASERS LTD ETC 01/01/2002 - 06/07/2018
APOLLO ENDOSURGERY, WEST LAKE HILLS, TX - INSPECTION RECS
Correspondence between CDER and Philadelphia district office
regarding KVK Tech 01/01/2006 - present
DEXCOM INC, SAN DIEGO, CA - 483 02/12/2018 - 02/16/2018
ROBERTSON MICROLIT LABORATORIES INC, LEDGEWOOD, NJ - 483
09/04/2014 - 09/09/2014
RECS RE Z-14192-2016 AERS ALGOVITA SPINAL CORD STIMULATION
K172258
K090217
FAP 2A3607 7A3975
Chemistry review, Bioequivalence review and Administrative
information/Correspondence for Nitazoxanide Tablets 500 mg
(Alinia)
PATHEON, MANATI, PR - EIR 05/08/2013 - 06/12/2013
ST JOHN'S WORT AERS
List of 483s issued to pharmaceutical, biologics and medical
device manufacturing facilities and clinical research
facilities and investigators in May 2018
FCN 1500
F121036903, F104212872, F95342455, ETC
INSPECTION DATA DRUGS, MEDICAL DEVICES 10/01/1999 - 06/07/2018
THE VAPOR BAR, MCKINNEY, TX - INSPECTION RECS
VENUSA DE MEXICO S, MEXICO BAYER MEDICAL SRL, COSTA RICA -
483, EIR 08/07/2014 - 10/27/2016
FLONASE RECS
FDA Memorandum dated May 19, 2005 on consumer exposure to
styrene-ethylene butadiene block copolymer that is referenced
in FCN 679.
ROMAINE LETTUCE DISTRIBUTION RECS 04/01/2018 - 06/07/2018
"Sexy Hair Concept" COSMETIC REGISTRATION
RONALD BUDZIK, MD, COLUMBUS, OH - EIR, 483, CORR 10/17/17
CASMARA COSMETICS SA, SPAIN - 483 05/29/2017 - 05/31/2017
NOVEL LABORATORIES, SOMERSET, NJ - EIR, 483, CORR 8/8/17
QUEST MANUFACTURING, DAYTONA BEACH, FL - EIR, 483, CORR 1/27/17

LUPIN LIMITED, INDIA - 483 05/08/2017 - 05/19/2017
GREER LABORATORIES, LENOIR, NC - EIR, 483, CORR 11/22/17
INVITRX THERAPEUTICS, IRVINE, CA - EIR, 483, CORR 4/25/16
STRAUMAN MANUFACTURING, ANDOVER, MA - EIR, 483, CORR 7/21/17

LIST OF 483S DEC 2017
MedWatch form for FDA Case ID:14375151
ROYAL CANIN USA, FREMONT, NE - EIR, 482, 483 ETC 01/01/2013 -
06/08/2018
ACCUPAC, LAKEWOOD, NJ - EIR, 483, CORR 2/14/17
ANALYTICAL CONTROL SYSTEMS, FISHERS, IN - EIR, 483, CORR
2/29/16
DR REGINALD SAMPSON, LANCASTESR, CA - EIR, 483, CORR 8/18/17
BELL-MORE LABORATORIES, HAMPSTEAD, MD - EIR, 483, CORR 5/26/16

BIO-RAD LABORATORIES, HERCULES, CA - EIR, 483, CORR 2/25/16
KASEL ASSOCIATES INDUSTRIES, DENVER, CO - 483, 482, EIR ETC
01/01/2012 - 12/31/2014
Basic information on all applications for Breakthrough Therapy
Designation (BTD) submitted to CDER or CBER during this period
see letter for details 01/01/2012 - 06/08/2018
RARITAN PHARMACEUTICALS, EAST BRUNSWICK, NJ - EIR, 483, CORR
10/20/16
2036940 2036943 PET SAFETY REPORTS, SAMPLE RESULTS
K160870
TRACE MINERALS RESEARCH, CANADA - EIR 06/01/2017 - 05/31/2018

MARS PETCARE, ALLENTOWN, PA - 482, 483, EIR ETC 01/01/2008 -
12/31/2010
Documents related to the 2015 American Snuff Company recall of
Grizzly and Kodiak branded smokeless tobacco products
DIAMOND PET FOOD PROCESSORS OF SC, LLC, GASTON, SC - EIR, 482,
EIR ETC 01/01/2010 - 06/08/2018
MARS PETCARE US, INC, COLUMBUS, OH - UNTITLED LETTER
07/01/2017 - 06/08/2018
OPENBIOME AKA MICROBIOME HEALTH RESERACH - AERS FECAL
MICROBIOME TRANSPLANT PRODUCTS 01/01/2013 - 06/08/2018
SYNGENE INTERNATIONAL LTD, INDIA - 483 01/24/2018 - 01/26/2018

Documents related to the 2017 U.S. Smokeless Tobacco Company
voluntary recall of Cope, Copenhagen, Husky, and Skoal branded
smokeless tobacco products
PERTILITY PARTNERSHIP, ST PETERS, MO - EIR, 483, CORR
02/21/2018 - 03/05/2018
K993900
CELLTRION - 483, WARNING LETTER 01/01/2018 - 06/08/2018
OTSUKA PHARMACEUTICAL CO LTD, JAPAN - 483 03/01/2018 -
03/31/2018
MICROBIOPHARM JAPAN CO INC, JAPAN - 483 03/01/2018 - 03/31/2018

2018-1707 2018-2919
Little, A. D., Inc. Report to the National Peanut Council,
"Assessment of the Effects of Possible Aflatoxin Guideline
Changes for the Peanut Industry," 1974
NOVA DISTRIBUTORS LLC - CORR WITH FDA RE WARNING LETTER
11/17/2017 - 06/10/2018
DEN180001 DECISION SUMMARY DE NOVO RECS
K092837
K171301
K960791
1) Transcripts from Pharmacy Compounding Advisory Committee,

October 27-28, 2015 2) Pre-meeting reports and data related to
domperidone at the Pharmacy Compounding Advisory Committee,
October 27-28, 2015 ETC
SMOKELESS TOBACCO CO LLC - SE0012626, SE0012633 UNREDACTED
SUMMARY
PHILLIP MORRIS USA - SE0004287, SE0004290, SE0004291, ETC
UNREDACTED SUMMARIES
K160836
MARS PETCARE, COLUMBUS, OH - EIR
WELLBUTRIN - ADVISORY COMMITTEE MTG
ZIEGENFELDER CO - AERS 1/18 TO PRESENT
BANABA - INFORMATION
SGLT2 INHIBITORS - AER
PROPRANOLOL (INDERAL) AER, LBLG
SYNERGY HEALTH STERILIZATION UK LTD, BRADFORD, WEST YORKSHIRE,
ENGLAND - DMF 6555
FAERS - 14335706, 14319470, 14275193, ETC
PATHEON INC - NEO MEDROL ACNE LOTIOIN SHIPPING DOCUMENTATION
MEDTRONIC - COVIDIEN TYCO SURGIPRO MESH RECALL
IDIVIDUAL RECS
DUKE CLINICAL RESEARCH INSTITUTE, DURHAM, NC - 483
483'S ISSUED 2017
COURSES COMPLETED BY DAVID T GLOVER
MASSOUD MOTAMED, MIND M CHOU, CHERYL A CLAUSEN ETC CV
06/11/2017 - 06/11/2018
Sucralose Food Additive Petition
RECS RE MOLLY & DREW ORIGINAL BEER BREAD MIX RECALL 01/01/2016
- 06/11/2018
SYNERGY HEALTH WESTPORT LTD, MAYO, IRELAND - DMF 10255
ABBVIE, NORTH CHICAGO, IL - CORR WITH FDA, EIR, 483 ETC
01/02/2017 - 06/11/2018
INGREDION INCORPORATED, INDIANAPOLIS, IN - EIR 12/07/2015 -
06/11/2018
THIRTY-TWO DEGREES, LLC, HAMEL, MN - EIR 05/02/2018 -
06/11/2018
MASS GENERAL HOSPITAL LABORATORIES, BOSTON, MA - 483 04/01/2018
- 06/11/2018
ADMA BIOLOGICS, BOCA RATON, FL - 483 APRIL 2018
KVK TECH INC, NEWTOWN, PA - INSPECTION RECS 2013
Stability data section 2.1.P.8 Stability, in relation to Xiidra

(lifitegrast 5% solution, eye drops) from Shire and Blephamide
(sulfacetamide sodium and prednisolone acetate ophthalmic
10%/0.2% suspension, USP) from Allergan ETC
NDA 016727
NDA 007335
HOSPIRA BOULDER, INC 483, WARNING LETTERS ETC 01/01/2013 -
06/08/2018
SYNERGY HEALTH STERILIZATION UK LTD, READING, BERKSHIRE,
ENGLAND - DMF 6554
INNOVIZE, NORTH OAKS, MN - EIR 02/29/2016 - 02/29/2016
DAEWOONG PHARMACEUTICALS CO LTD - EIR 05/16/2018 - 05/16/2018

NDA 050450
NDA 050495
K160895 K133386 K120578 ETC
Food Contact Notifications (FCN) 770, 1056, 1473, and 1778
SUCRALOSE FAP
K094038
K094038
ADVERSE EVENT RECS
SYNERGY HEALTH, MARSEILLE, FRANCE - DMF 10733
ETHIBOND - RECALL
FDA-SS-1116099 - FINAL DECISION
2016-2331 2017-380 2017-3164 etc
WHPM INC, IRWINDALE, CA - EIR 11/12/14, 11/13/14
VAGIFEM, YUVAFEM, ETC AERS
CAITO FOODS LLC, INDIANAPOLIS, IN - INSPECTION REPORTS, WARNING
LETTERS, RECALLS ETC 01/01/2008 - 06/11/2018
AERS 12613898 1092810411476505ETC
Most recent label (last updated on 27th April 2018 through
Suppl-037) for TRIZIVIR (NDA# 021205)
IDE, PMA, 510K LASKY CLINICAL TRIALS ETC 06/11/2011 -
06/18/2018
INCLUSION, EXCLUSION CRITERIA SERZONE CLINICAL TRIALS Date
Range: 01/01/1985 - 12/31/1994
INCLUSION, EXCLUSION CRITERIA CLINICAL TRIALS REMERON
01/01/1985 - 12/31/1997
EVANGER'S DOG & CAT FOOD CO, WHEELING, IL, MARKHAM, IL - 4383,
482, EIR ETC 01/01/2009 - 12/31/2013
EVANGER'S DOG & CAT FOOD CO, WHEELING, IL, MARKHAM, IL - 483
482, EIR ETC 01/01/2010 - 12/31/2013
482, EIR 2011
INDIVIDUAL RECS
482, EIR ETC 2012
SUN PHARMA, HALOL, INDIA - EIR 05/01/2018 - 06/13/2018
K153736
INCLUSION, EXCLUSION CRITERIA PAXIL CLINICAL TRIALS 01/01/1993
- 12/31/1999
SPINOS LIFESCIENCE AND RESEARCH PRIVATE LIMITED, INDIA - EIR
MAY 2018
INCLUSION, EXCLUSION CRITERIA EFFEXOR
BOVIE MEDICAL CORPORATION, CLEARWATER, FL - EIR 07/27/2015 -
07/30/2015
CSL PLASMA, INC, TUCSON, AZ - EIR 08/01/2017 - 08/31/2017
CORR BETWEEN CTP & ALTRIA PHILIP MORRIS
CORR FROM CBER RE CLINICAL TRIAL NCT00092534 TO MERCK SHARPE &
DOHME
Xcaliber SE records
K173214
12268449 11950881 11516280 etc
K100488
BLACK MAMBA PREMIUM ETC - LAB ANALYSIS, TESTING, RE PUBLIC
NOTICES 04/01/2012 - 06/01/2018
EXPORT CERTIFICATES TO IRAQ BY GENERAL ELECTRIC ETC
INCLUSION, EXCLUSION CRITERIA ZOLOFT CLINICAL TRIALS
SAFIRSTEIN, BETH, MD, HALLANDALE BEACH, FL - 483 04/01/2009 -
06/30/2009
CORR BETWEEN FDA AND DR KENNTH MUKAMAL, BETH ISRAEL DEACONESS

MEDICAL CENTER MODERATE DRINKING STUDY 12/01/2015 - 05/01/2017
ANNUAL BUDGET RPT 2014-2017, CTP SALARIES, CIVIL PENALTY AWARDS
2014-2017
COSMETIC REGISTRATION RECS
FCN 1854
FDA/CDER Certificates of Pharmaceutical Products CERTIFIED
BRISTOL MYERS SQUIBB - RUBRAMIN PC NDA 6-799 LBLG
FOOD CONTACT SUBSTANCE PHOSPHONIC ACID
DEN 140044, DEN 160026, DEN 170046
PHARMEDIUM, LAKE FOREST, IL CLEVELAND, MS DAYTON, NJ - EIR,
483 1/1/16 TO PRESENT
MILLSTONE MEDICAL OUTSOURCING INC, LLC, OLIVE BRANCH, MS - EIR
04/30/2018 - 05/01/2018
J&L MEDICAL SERVICES LLC, CT, MA - EIRS, 483S, WARNING LTRS
1/1/98 TO PRESENT
PRAXBIND, KECENTRA - ORPHAN DRUG DESIGNATION
COMMONWEALTH BRANDS INC - UNREDACTED RVW
OZURDEX NDA 22-315/S003
BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM - FDA RULING ON THE
FORFEITURE OF 180-DAY EXCLUSIVITY
INDIVIDUAL RECS
KEEFE COFFEE - RECS
MIRACLE FRUIT PRODUCTS - APRVL RECS 1974
J LIEB FOODS, INC, FOREST GROVE, OR ETC - 483 06/12/2013 -
06/12/2018
ROMINGER MEDIZINTECHNIK GMBH, SEITINGEN OBERFLACHT, GERMANY -
EIR 12/11/13
REISDORF BROS FEED MILL, NY - INVESTIGATION RECS, INSPS, CORR,
ETC 12/15
PREMIER CLINICAL RESEARCH, SPOKANE, WA - EIR, 483, CORR
11/29/17
ABBVIE - 483 12/01/2017 - 12/31/2017
DAEWOONG PHARMACEUTICALS, SOUTH KOREA - 483 11/117
DMF 009225
Docket 74-20155
NDA 21041 SUPPLEMENTS, RECALLS ETC
ANDA 075467
CORR BETWEEN FDA AND CHILDREN'S HOSPITAL OF PHILADELPHIA RE
POLYETHYLENE GLYCOL 3350
K162817
ELITE LABORATORIES, NORTHVALE, NJ - EIR, 483, CORR 4/24/27
EI LLC, KANNAPOLIS, NC - EIR, 483, CORR 10/6/17
PC MARKETING, RIDGEFIELD, NJ - EIR, 483, CORR 1/19/17
QUALGEN, EDMOND, OK - EIR, 483, CORR 5/10/17
K113732
CORIXA CORPORATION DBA GLAXOSMITHKLINE VACCINES, MARIETTA, PA -
EIR, 483, CORR 5/16/17
CRANE USA, ITASCA, IL - EIR, 483, CORR 4/26/17
HHSF223201400016B
BIOPHOTAS, TUSTIN, CA - EIR, 483, CORR 4/6/16
K122980
ALLERGAN, INC, IRVINE, CA - EIR, 483, CORR 09/01/2016 -
09/01/2017
K161700
SMITH VALLEY DAIRY, WELLINGTON, NV - 483 01/01/2016 -
01/06/2018
2/20/1985 GUIDANCE: REQUIREMENTS PROPOSED FOR PUMP INSULINS AND
INSULIN PUMPS
Complete Response Letter insulin glargine Mylan
BAXTER SODIUM CHLORIDE APPROVAL OF MANUFACTURING PLANT, TEST
DATA, AERS 01/01/2011 - 12/20/2017
COMMUNICATIONS BETWEEN RECOMBINETICS AND OC, CFSAN, CVM, ETC
01/01/2012 - 05/01/2018
Daily FOIA log from 11/4/17-1/15/18
NDA 020204
RECS RE PETITION ABBOTT LABORATORIES TO AMEND FEDERAL

REGULATION TO PROVIDE FOR THE SAFE USE OF VITAMIN D3 AS A
NUTRIENT SUPPLEMENT IN MEAL REPLACEMENT BEVERAGES 01/01/2012 -
01/01/2015
HHSF223201400012B
Please provide a copy of the CRL sent to Sandoz for its ANDA
filing for ADAVIR
K141053
FOIA daily log from 5/22/18-6/15/18
RECS RE EXPAREL RE ALLEGATION, EVALUATION, CONCLUSION
ADVERTISEMENT OR PROMOTIONAL MATERIAL
Background information regarding the FDA presentation entitled
Scientific Basis for Swedish Match NA Premarket Tobacco Product
Authorization, dated April 6, 2017.
NDA 017741
GALAXY SURFECTANTS LTD, INDIA - 483 03/23/2018 - 03/30/2018

2017-7898 2017-7789 2017-7744 etc
K163474
GUARDIAN PHARMACY SERVICES - COMPOUNDED TRIAMCINOLONE-
MOXIFLOXACIN LAB ANALYSIS FOR SAMPLES 691816, 904017, 996864,
ETC
ETC
LAND MARKS PRODUCTS INC - LISTERIA OUTBREAK RECS 2017-2018,
CORR, RPTS, ETC
FY17 HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS FOR
HUMAN FOOD INSPECTIONS
FY18 HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS FOR
HUMAN FOOD INSPECTIONS
REPLICATION MEDICAL INC - GELSTIX INVESTIGATION RECS
PHARMACIA AND UPJOHN CO - CYKLOKAPRON NDA 19-280 SBA
BLA 125160/S283
Notice and comments board from the time it was posted to the
final rule for the "Food Labeling: revision of the nutrition
and supplement facts labels" rule 5/27/2016
2017-8697 2017 8713 2017 8743 2017-8921 2017-9004 2017-
9091
All clinical trial records and the FDA approval letters for the
measles-mumps-rubella (MMR) I and MMR II vaccine formulations
BK060015
GLENMARK PHARMACEUTICALS LTD, MONROE, NC - 483 05/14/2018 -
05/18/2018
RECS BETWEEN FDA AND DEBRA PAGANO, FDA CONSULTANTS LLC, CHITRA
SHARMA 01/01/2006 - 05/31/2018
2018-3603 2018-3608 2018-3659 etc
2017-433 2017-1196 2017-6608 etc
2018-2919 2018-3056 2018-3084 etc
K172356
NDA 203214/S18
BLA 103948/S5151
BK110061 BK120066 BK120057
TENOFOVIR ALAFENAMIDE MEDWATCH RECS
K050558
K073090
MEDTRONIC, MEMPHIS, TN - EIR 03/19/2018 - 03/19/2018
CPT1300232
K172191 APPROVAL LETTER
Documents related review of the 15 Xcaliber products for which

SE orders were issued on 05/10/2018, and the 6 Xcaliber
products for which SE orders were issued on 06/08/2018
K093659, K101431, K022236, ETC
2018-2207 2018 -2210 2018-2353 ETC
SRDAN VERSTOVSEK, HOUSTON, TX ETC - 483 09/17/2012 -
09/22/2017
K081754
MONAT GLOBAL CORP HAIRCARE PRODUCTS, MIAMI, FL - AERS,
COMPLAINTS ETC 01/01/2014 - 06/14/2018
Recs re carbon-graphite used in food processing/contact
applications
BK030033
LONZA AG, SWITZERLAND, JANSSEN PHARMACEUTICA, BELGIUM ETC - 483

UPDATED LIST OF DMF CBER PRODUCTS
QUESTIONS RE CBER GUIDANCE
ZIMMER BIOMET, WARSAW, IN - 483, EIR, CORR 03/15/2018 -
06/14/2018
CORR FROM ROD BLUM 1/16 TO 6/11/18
HENAN LIHUA PHARMACEUTICAL CO LTD, ANYANG, CHINA CHANGZHOU
TIANHUA PHARMACEUTICAL CO LTD, JINTAN, CHINA APICORE
PHARMACEUTICALS PVT LTD, PADRA, INDIA - 483
SECURITY VIDEO
NDA 17857
JOHNSON & JOHNSON - TRAMADOL LAWSUITS
LIVA NOVA, DEUTSCHLAND - MYCOBACTERIA INFECTIONS AT WELLSPUN
YORK HOSPITAL, YORK, PA 2014 TO PRESENT
JUZEN CHEM, TOYAMA, JAPAN 483 2018
BRENNTAG PACIFIC 483'S CA, AZ, ND, 2011-2018
WEST PHARM LIST OF 483'S DATE RANGE 2008-2018
FCN 1878
IDE G110001, DENALI FILTER K130366
510K SUMMARY K801208 K843557, K862926,
BARD ECLIPSE ANCHOR FILTER PRE-IDE MTG MATERIALS 2010 K102511

ANDA 206266 (Febuxostat Tablets) TENTATIVE APPROVAL 2018
K112605
SUSTOL SBOA (NDA # N022445) HERON THERAPS INC

DE NOVO DEN150011 SONACARE
K153023 EDAP TECHNOMED, INC
LUCENTIS BLA 125156 Supplement S110 APPROVED 10/13/16 APPROVAL
INFO
INTL ASSOC FOR FOOD PROTECTION MTG JULY 10, 2018 RECS
BARBARS SCHNEEMAN FORMER DIR CFSAN EMAILS DATE RANGE 01/01/2004
- 12/31/2012
INOGENT LABS, INDIA EIR 2015 FEI 3005851210
VALENS MOLECULES LTD, INDIA EIR 2016 FEI# 3001329340
RECS PASTEURIZATION OF EGGS
FCN 1604
NDA 019890
CLEAR LABS 2015 REPORT ON HOT DOGS EMAILS
DATA FOR FAST TRACK FOR CDER NEW DRUG REVIEW DIV FY2015,
FY2016, and FY2017
COMPLAINT AND ADVERSE EVENT DATA 10/01/1999 - 06/18/2018
DRUG SAMPLING AND TEST DATA 10/01/1999 - 06/18/2018
USSTC SE0012626 AND SE012633 MEMO
RECS RE DOCKET 83P-0404
B AND R PRODUCTS INSP RECS 2018 CUTLER BAY, FL
COOK PHARMICA, IN AND SAMSUNG BIO, KOREA 2018 483 AND NOTES
483's May 2018 LOS ANGELES
STAHLBUSH ISLAND FARMS, CARVALLIS, OR - INSPECTION REPORT
06/01/2017 - 08/31/2017
CASE NUMBERS: 14566707 11658233 14677496 14365267 14353330

14347023 14322988 14318601 14318557 13614541 14277157 10035170
MONAT GLOBAL, FL INSP RECS, COMPLAINTS AND FOIA REQUESTS DATE
RANGE: 09/29/2014 - 06/15/2018 HAIR CARE PRODUCT
LISTING OF INSPECTIONS, INSPECTION CITATIONS 06/15/2017 -
06/15/2018
KRATOM SAMPLE TESTING 02/05/2018 - 06/15/2018
DRUG REGISTRATION LIST 01/01/2017 - 06/15/2018
NDA 017606
NDA 21536
483s issued by the Minneapolis DO in May 2018
483s issued by the Philadelphia DO in May 2018
483s issued by the New Orleans DO in May 2018
HARBINGER MEDICAL GROUP LL, LAFAYETTE, LA - EIR 01/01/2016 -
01/15/2018
483s issued by the New England DO in May 2018
483s issued by the New York DO in May 2018
483s issued by the New Jersey DO in May 2018
483s issued by the San Francisco DO in May 2018
483s issued by the San Juan DO in May 2018
483s issued by the Seattle DO in 2018
483s issued by Atlanta DO in May 2018
483s issued by CBER International Operations Office in May 2018

483s issued by CDER International Operations Office in May 2018
483s issued by the CDER International Operations Office in May
2018
RECS RE DETERMINATION THAT FERMENTATION PROCESS FOR MANUFACTURE

OF VANILLIN IS A NATURAL PROCESS RESULTING IS A NATURAL PRODUCT
NDA 018651 SBA
483s issued by the CDRH International Operations Office in May
2018
483s issued by the Chicago DO in May 2018
483s issued by the Cincinnati DO in May 2018
483s issued by the Dallas DO in May 2018
483s issued by the Denver DO in May 2018
483s issued by the Detroit DO in May 2018
483s issued by the Florida DO in May 2018
483s issued by the Kansas City DO in May 2018
CARMUSTINE NDA 017422
NDA 017422 Chemistry Review
CORR WITH FDA RE ESTABLISHMENT OF MEDICAL DEVICE CLASSIFICATION
882.1561 01/01/2016 - 01/15/2018
FDA Memo from Heinz J. Eierman dated August 28, 1978 titled
"Health Research Group Inquiry on Talc Safety."
US NONWOVENS CORP, BRENTWOOD, NY - EIR 06/01/2012 - 06/19/2018

INDIGO CARMINE INJECTION AERS
NDA 019329 NDA 018897
ANDA 077707 SBA
BOSTON SCIENTIFIC, DORADO, PR - EIR MAY 2017
JUUL RESPONSE TO LETTER, ETC 03/01/2018 - 06/18/2018
GALAXY SURFACTANTS LIMITED, RCHEM PRIVATE LIMITED, WANBURY
LIMITED, INDIA - 483 03/01/2018 - 03/31/2018
RECS RE180-DAY EXCLUSIVITY BUPRENORPHINE, NALOXONE
FDA review documents for biosimilars approved in 2017 and 2018
that did not have an FDA Advisory Committee meeting prior to
approval
K905164
Exforge Abbreviated New Drug Applications
Docket Numbers 94P-0420 and FDA-2008-P-0309-0001/CP - RECS
RELIED ON BY FDA IN RESPONSE
Medical Reviews for the following biosimilars approved in

2017: Renflexis (Infliximab-abda), Cyltezo (Adalimumab-adbm),
Mvasi (Bevacizumab-awwb), Ogivri (trastuzumab-dkst), Ixifi
(infliximab-qbtx), Retacrit (epoetin alfa-epbx), Fulphila
(pegfilgrasti
K140910
Roxarsone ADVERSE EVENT RECS

K944650
Transcript of December 1994 Gastrointestinal Advisory Committee
hearing re: Prevacid application
K780872
The FDA orphan drug designation request for flunarizine for the
treatment of alternating hemiplegia
FDA Memo dated July 11, 1984 from John A. Wenringer re: Denial
of Petition for Labelling of Warning of the Hazardous Effects
Produced by Asbestos in Cosmetics Talc from Philippe Douillet
K121812, K111818, K120349 ETC
K820771
NDA 021897
P030054 S274
Documents regarding FDA draft guidance entitled Selection of

the Appropriate Package Type Terms and Recommendations for
Labeling Injectable Medical Products Packaged in Multiple-Dose,
Single-Dose, and Single-Patient-Use Containers for Human Use
Guidanc
K944649
IRIDICA BAC BSI 510k
2018-3876
CVM CLINICAL RESEARCH PROTOCOLS ETC 01/01/2013 - 06/19/2018
K093159 FIRST PARTY
Summary Basis of Approval for ANDA 078873
NDA 019890 & NDA 017857
NDA 021081
CVM ADE Comprehensive Clinical Detail Report Listing for the
following drugs: afoxolaner, fluralaner, sarolaner
NDA 209269
RECS RE OSE Review of the Xie, et al. publication (OSE RCM#
2016-939) and the OSE Review of the Lazarus et al. publication
(OSE RCM #2016-166) ETC
K140390
NDA 021081/S-062
NDA 021536/S-031 and S-051
RECS RE ALUMINUM ZIRCONIUM IN ANTIPERSPIRANTS
Electronic version of the FDA orange books from 1984-2010
TORAY INDUSTRIES, INC. SETA PLANT, OTSU, JAPAN - 483 07/01/2017
- 07/31/2017
K103195
TOMITA PHARMACEUTICALS, JAPAN - EIR 3/9/2018
HARVONI AERS
K041112
CITY OF HOPE NATIONAL MEDICAL CENTER IRB, DUARTE, CA - 483
01/01/2016 - 01/30/2016
GUOBANG PHARMACHEM GROUP CO LTD, CHINA - EIR 09/01/2015 -
12/31/2015
FAP 2281 POST FILING CORR
SCM-2023002-3 IMPORT RECS
LA TIENDA INC - IMPORT DATA
GUOBANG PHARMACHEM GROUP CO LTD, CHINA - 483 09/01/2015 -
12/31/2015
AJINMOTO ALTHEA, INC, SAN DIEGO, CA - 483 03/28/2017 -
04/06/2017
K012126 K063148 K961758 ETC
OCULAR THERAPEUTIX, BEDFORD, MA - INSPECTION CLASSIFICATION
RECS 05/04/2017 - 06/05/2018
ADMA BIOLOGICS INC, BOCA RATON, FL - EIR 04/02/2018 -
07/31/2018
INTERTEK PHARMACEUTICAL SERVICES, SAN DIEGO, CA - 483
K180818
RECS RE GLENDALE WAREHOUSE & DISTRIBUBTION CORP ETC FSVP
AJINOMOTO ALTHEA INC, SAN DIEGO, CA - INSPECTION RECS
05/23/2017 - 06/01/2017
MYLAN PHARMACEUTICALS INC - ZONALON (DOXEPIN HCL) NDA 20-
126/S001,S002,S003,S004 SBAM RVWS, LBLG, ETC
NDA 020563/S-040
CORIN MINIHIP FEMORAL STEM - RECS, CORR
K171958
ADVISORY COMMITTEE MEETING MINUTES
NDA, BLA APPLICATION INFORMATION
K140082
FOIA LOGS EXCEL 05/14/2018 - 06/20/2018
ANDA 090141
K132119
510(k) submission information is being requested for: Excel
Excel Cerebral Cooling System Excel Cooling Element Excel
Cryo Cooling Element Extreme
FCN 1553
LISTERIA OUTBREAK STONE FRUIT RECALL 2014 - RECS
The inspections done of the plant(s) manufacturing Kellogg's

Honey Smacks in relation to that multistate salmonella outbreak
FRESENIUS KABI ONCOLOGY LTD, NADIA, INDIA - 483 5/24/17
PINNACLE FOOD GROUPS, INC, JACKSON, TN - INSPECTION RECS,
RECALL RECS 04/20/2017 - 06/15/2017
LIST OF FOIA REQUESTS THAT RESULTED INDATA THAT WAS DELIVERED
VIA DC/DVD
NDA 019839 NDA 020031 NDA 020151 ETC
NDA 202833
NDA 020723
K032104
K172258
NUPLAZID AERS
ETC
records and correspondence related to the FDA Sentinel review
of Nuplazid (pimavanserin) that are able to be released
ETC
BLANCA O JORDAN, ABBVIE, INC, NORTH CHICAGO, IL - 483
11/01/2017 - 06/21/2018
HEPLOCK, HEPERINE, X-RAYS, HYPNOSIS RECS
MYLAN LABORATORIES, INDIA - 483 09/05/2016 - 09/30/2016
JIANGXI FUSHINE PHARMACEUTICAL CO LTD, CHINA - EIR 06/22/2014 -
07/06/2014
DKT 2004P-0214
FAERS NUPLAZID, INGREZZA, KUVAN ETC
ZIMMER CONTINUUM LONGEVITY LINER - CMPLNTS, RECALL RECS
NDA 208246 NDA 203496 ORENITRAM
ELI LILLY - CYMBALTA AERS, STUDIES, WARNINGS
COMMUNICATIONS FDA PROTON PUMP INHIBITORS AND CHRONIC KIDNEY
DISEASE ETC
SUMMARY OF INSPECTIONS OF ANIMAL FOOD FACILITIES 10/03/2017 -
12/22/2017
INDIVIDUAL RECS - VAERS RPT
Pred Forte (Prednisolone Acetate) Ophthalmic Suspension 1%
Sterile Product Formulation - ingredients, manufacturing
process, Formulation product Patent numbers
SERTRALINE AERS
TRIIODOTHYRONINE AERS
1VIT05006 (NCT00740246) 1VIT03001 (NCT00396292) 1VIT05005
(NCT00317226) ETC
Atropine Sulfate Ophthalmic Solution, USP, 1%, (Manufacturer

Akorn, Inc., Application NDA 206289) Product Formulation
HEMLIBRA AERS
RAJBHOG FOODS PVT LTD, FLUSLHING, NY - EIRS 1/1/13 TO PRESENT

K163217
DEN180001
PHARMAVITE, OPELIKA, AL, NATURE MADE - INSPECTION RECS, RECALL
RECS 06/02/2016 - 06/21/2018
HYLAND HOMEOPATHIC - BABY TEETHING HOMEOPATHICS - AERS 2009.
2010
K172236
Number of INDs that CBER received for vaccines from the
earliest possible date to the most recent date
K110386
RECS RE FDA GUIDELINES FOR TESTING WHITE PETROLATUM
EXTERNAL COMM RE POLARITYTE, INC TISSUE PRODUCT SKINTE FROM
COMPETITORS 06/29/2016 - 06/18/2018
R&D SYSTEMS, INC, MINNEAPOLIS, MN - 483, EIR, RESPONSE ETC
BK130068
DEN170043 DEN170088
FCN 132
CHURCH & DWIGHT CO, INC, VANCOUVER, WA - EIR AND ATTACHMENTS,
EXHIBITS 10/19/2015 - 09/30/2016
O2 CONCEPTS, NEWTOWN, CT - EIR 12/3-6/13
K103340
K080959 K070536
K052925
K021605
NADA 128-620
Sections 1.13 - 1.17 NDA 021618
CITRA LABS, BRAINTREE, MA - EIR, 483, CORR 9/27/17
AMAG PHARMACEUTICALS, WALTHAM, MA - EIR, 483, CORR 6/15/16
ABS CORPORATION, OMAHA, NE - EIR, 483, CORR 2/27/17
KIM CHEMICALS PRIVATE LTD, INDIA - 483 06/05/2017 - 06/09/2017

BRISTOL MYERS SQUIBB PHARMACEUTICAL RESEARCH INSTITUTE, EAST
SYRACUSE, NY - EIR, 483, CORR 9/16/16
BIOZONE LABORATORIES, PITTSBURG, CA - EIR, 483, CORR 1/26/16
FRESENIUS KABI USA, GRAND ISLAND, NY - EIR, 483, CORR 2/4/16
GRIFOLS BIOLOGICALS, LOS ANGELES, CA - EIR, 483, CORR 8/24/17

GLAXOSMITHKLINE DBA HUMAN GENOME SCIENCES, ROCKVILLE, MD - EIR,
483, CORR 4/11/16
BENTLEY LABORATORIES, EDISON, NJ - EIR, 483, CORR 6/9/17
OEYAMA-MOTO MEDICAL GROUP FOUNDATION, INC, WEST COVINA, CA -
EIR, 483, CORR 08/07/2017 - 08/11/2017
ADVANCED MAGNETIC RESEARCH INSTITUTE IRB, LAS VEGAS, NV - EIR,
483, CORR 10/26/16
LANNETT COMPANY, PHILADELPHIA, PA - EIR, 483, CORR 9/16/16
BIOMERIEUX, HAZELWOOD, MO - EIR, 483, CORR 1/25/17
CHARLES RIVER LABORATORIES, WORCESTER, MA - EIR, 483, CORR
7/12/13
SF-311 FORMS ETC
No. 1380, filed by Troy Corporation, for the reaction products
of paraformaldehyde (CAS Reg. No. 30525-89-4) and ethylene
glycol
K162172 K131305 K150861 ETC
K162172, K131305, K150861, ETC
PQ CORPORATION, UTICA, IL - EIR REDACTED, UNREDACTED 05/31/2017
- 06/25/2018
K971794
K170957
ADMA BIOLOGICS, INC, FLORIDA - 483 01/01/2018 - 06/25/2018
GRAS submissions/rebuttals regarding company Biothera Inc and
its beta glucan products
Official tissue residue method for melengestrol acetate in
cattle tissues
Official tissue residue method for monensin in cattle tissues

UNITED SAFETY AGENTS FSVP RECS 06/15/2018 - 07/25/2018
RECS RE REFUSAL OF ENTRY BAOLINGBAO 36YYW99
FDA OPEN MEETING MEDICAL DEVICE QUALITY SYSTEM REGULATION
TRANSCRIPT ETC 08/01/1995 - 09/30/1995
RECS RE 3M FORCED AIR WARNING DEVICE, RECS RE DEAR HEALTH CARE
PROVIDER LETTER 01/01/2016 - 06/25/2018
STANDARD HOMEOPATHIC COMPANY, HYLANDS, LOS ANGELES, CA -
INSPECTION RECS, COMPLAINTS, ETC 01/01/2015 - 06/25/2018
ARROW RELIANCE WARNING LETTER RECS 04/02/2018 - 06/25/2018
BAXTER HEALTHCARE CORPORATION, IRVINE, CA - EIR 02/21/2017 -
03/03/2017
Official tissue residue method for chlortetracycline in cattle
tissues
QUANTITATIVE INSIGHTS INC - RADIOLOGICAL COMPUTER-ASISTED
DIAGNOSTIC SOFTWARE DE NOVO APPLICATION
VALEANT PHARMS, BAUSCH & LOMB INC, ALCON LABS - TETRACAINE HCL
COMM 2/28/16 TO PRESENT
LISTS, INDICES, ETC RE HISTORICAL STUDIES PRODUCED OR
COMMISSIONED BY AGENCY HISTORICAL STAFF ETC
ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY - GUIDELINES TO REPORT
CONTENT 06/01/1951 - 06/22/2018
FERRING PHARMACEUTICALS, CHINA - 483 12/01/2011 - 12/31/2011

2017-6972 2017-3967 2017-577 2017-8829 2017-3839 2018-812
2017-1609 2017-2565 2017-2603 2017-4457
All meeting minutes, meeting agendas, or decision logs created
between 11/01/2017 05/31/2018 by the FDA Nicotine Steering
Committee
AROMASIN NDA 20-753, ARIMIDEX NDA 20-541, FEMARA NDA 20-726 -
APRVL RECS
IND 112,290 Serial Numbers: 0010, 0011 and 0012
Inactive ingredient ethyl alcohol in bupropion XL 300mg,
manufactured by Par NDC 10370-102-03
IMBRUVICA NDA 210563 SBA
QUIDEL CORP, DIAGNOSTIC HYBRIDS INC - IMMULITE 2000/2000 XPI
TSI ASSAY K152061 RECS
CERNO PHARMACEUTICALS, MIAMI, FL - 483 11/13/2017 - 11/17/2018

FAERS detailed report for Ocaliva (obeticholic acid) from
04/01/2018 to the present
FAERS detailed report for Nuplazid (pimavanserin), from
04/01/2018 to the present
IDE Number G050134, GS Filter
RECS RE LETTER 10/13/17 LETTER TO CDRH FROM BRYAN CAVE RE
SMILEDIRECTCLUB USE OF MEDICAL DEVICES INCONSISTENT WITH
RELEVANT 510KS
NDA 21018/S34
K173452
NDA 20986/S2
2018-1616 2017-4276 2016-5299 2ETC
Medication error reports for insulin pen devices
Internal and external communication/correspondence related to

the Reclassification of Non-Invasive Bone Growth Stimulator
from class III to class II medical device 1/1/2014-7/1/18
K172831
FOIA requests, and their responses, from 8/1/2017 to 5/1/2018,

that involve the company MiMedx Group Inc, or MiMedx
Establishment Inspection Report, Form FDA 483 and
Correspondence: Zep, Inc., Emerson, GA End dates of inspection:
July 23, 2015
Correspondence: Altaire Pharmaceuticals, Aquebogue, NY March
09, 2017
Correspondence: Acorda Therapeutics, Ardsley, NY February 29,
2016
Correspondence: AP.I. Solutions, Daphne, AL End dates of
inspection: August 31, 2016
Correspondence: BioLife Plasma Services, Greenwood, IN August
27, 2017
Correspondence: bioMerieux, Durham, NC January 05, 2016
Correspondence: .Decimal, Sanford, FL May 01, 2015
Correspondence: Elba, Troy, MI October 05, 2017 FDA
Correspondence: Halyard Health, Alpharetta, GA November 11,
2016
Correspondence: Wenzel Spine, West Lake Hills, TX March 11,
2016
Correspondence: Fisher Bioservices IRB, Germantown, MD May 14,
2015
Correspondence: Sage Products, Cary, IL September 01, 2016
Correspondence: Genentech, South San Francisco, CA July 08,
2016
Correspondence: Frontida BioPharma, Philadelphia, PA March 31,
2017
MEDICAL REVIEW RECS NDA 022137, 022195, 022207, ETC

FDA FOIA Request Logs from 01/01/2013 to 05/31/2018
RECS RE RECALL CHIP N DIPPED CHOCOLATE BARS, HUNTINGTON, NY
Recs re Advanced Notice of Proposed Rule Making, Oral Health
Care Drug Products for OTC Human Use Establishment of a
Monograph"
Records relating to the Advanced Notice of Proposed Rule

Making, Oral Health Care Drug Products for Over-the-Counter
Human Use Tentative Final Monograph for Oral Antiseptic Drug
Products,
K162475
Information regarding the Oncology Drug Advisory Committee
meeting held on July 2010
MEDISCA INC - EIRS, 483S, WARNING LTRS, ETC
All materials reflecting or relating to FDAs participation in

meetings or other activities of the Cosmetic Ingredient Review
(CIR) related to issuance of the May 1, 1993 publication, Final
Report on the Safety Assessment of Chlorhexidine/Chlorhexidine.
INNOVATIVE STERILIZATIONS TECHNOLOGIES LLC - ONE TRAY
STERILIZATION TRAY K052567
New Drug Application (NDA) for Epidiolex
PHARMA SOLUTIONS, LLC, EARTH CITY, MO - COMPLIANCE, LICENSING,
INSPECTIONS 06/09/2015 - 06/26/2018
THAYER INTELLECTUAL PROPERTY INC - MANOS DVC WARNINGS, CLNCL
TRIALS, MDRS, ETC
ARROW RELIANCE INC DBA DARWIN'S NATURAL PET PRODUCTS - LAB
RPTS, ANALYSES, RESULTS, ETC 3/15/18 TO PRESENT
2018-4764
ABILIFY - AERS
ANTRIM PHARMS - ESCITALOPRAM ORAL SOLUTION ANDA 203-967
NDA 20-753/S006, NDA 20-541/S024, NDA 20-726/S005,008,S011 -
EFFICACY SUPPLEMENTS
SYNAPTIC 4000 PRO/NEUROGENX 4000 PRO - APRVLS, DENIALS,
CLEARANCES, ETC
AUROBINDO PHARMA LTD - METHENAMINE MANDELATE TABS ANDA 205-661
SBA
AVINGER INC - PANTHERIS SYS K173862
HIP PROSTHESES P040033, K083566, K052808, ETC
SMITH & NEPHEW - BHR HIPS P040033
PATHEON NV, WUXI APPTEC - 483 01/01/2008 - 06/01/2018
Meeting minutes since 1/1/2017,within the TRG (Tissue Reference
Group) that mention MiMedx or MiMedx Group Inc 01/01/2017 -
06/26/2018
Adverse Event Reports in regards to Amnion and/or Placenta
based HCT/P 361 products
All materials relating to the use of chlorhexidine as an
inactive ingredient in a mouthwash
WEEKLY FOIA LOG
XINXIANG PHARMACEUTICAL CO LTD, HENAN, CHINA - 483 09/01/2015
- 10/05/2015
Grandfather Determination Letter (Tobacco Product, Cigar) for
GF1601685
EPIDIOLEX, CANNABIDIOL, CBD ETC STUDIES, REPORTS ETC 01/02/2006
- 06/30/2018
Records relating to the Advanced Notice of Proposed Rulemaking,

Oral Health Care Drug Products for Over-the-Counter Human Use
Antigingivitis/Antiplaque Drug Products Establishment of a
Monograph Proposed Rules, published May 29, 2003, at Volume 68
o
CORR RE MEETING REQUEST, AGENDA, ETC BETWEEN INDIVIOR AND
REBECCA WOODS, ELIZABETH WOODS, OCC 11/01/2017 - 06/30/2018
CORR, AGENDA, ETC RE MEETING BETWEEN GRAIL SIPES, SANJA SITLANI
11/01/2017 - 06/30/2018
CID-2017891-3, CID-2017892-1, CID-2017894-7 ENTRY RECS
FDA APPROVAL LETTERS ANDA 040050 ETC
2017-1404
MAC-CHEM PRODUCTS INDIA PVT LTD, INDIA - 483 04/01/2018 -
04/30/2018
K181051
HCT/P 361 ADVERTISING PROMOTIONAL COMMERCIAL LABELING LETTERS,
RESPONSES 10/01/2017 - 06/26/2018
2017-3895
XINXIANG TUOXIN BIOCHEMICAL CO LTD, CHINA - 483 09/01/2015 -
10/05/2015
NDA 202833
ANDA 210256 SBA
ANDA 208841 SBA
ANDA 077511
ANDA 209506
Speaker presentations from the June 25-26 2018 CBER Science
Symposium to post on the AABB website
ANDA 210208
FCN 1864 FCN 1582
P100006/S005
BIOTEST PHARMACEUTICAL CORPORATION, BOCA RATON, FL - EIR
07/01/2017 - 07/31/2017 (FIRST PARTY)
CONAGRA BRAND, INC, OAKDALE, CA - CASE 149680
VIRCHOW BIOTECH PRIVATE LTD, INDIA ETC 483 11/03/2014 -
12/11/2015
Biotechnology Consultation BNF151 Submission, received by FDA
on July 1, 2015
DBLA 125085/S-319
ECIGARETTE AERS
ANDA 208077
FOI DAILY LOG 5/28/18-6/1/18
FOI DAILY LOG 5/28/18-6/1/18
FOI DAILY LOG 5/28/18-6/1/18
FOI DAILY LOG 5/28/18-6/1/18
FOI DAILY LOG 5/28/18-6/1/18
FOI DAILY LOG 5/28/18-6/1/18
CORR WITH EXPRESS SCRIPTS, INC, INVESTIGATION RECS 05/01/2017 -
06/26/2018
GUANGZHOU BILIAN BIOTECHNOLOGY CO LTD, HONG KONG - REGISTRATION
INFO COSMETICS 03/01/2018 - 06/27/2018
OCI CERTIFIED INVENTORY OF EVIDENCE FORM - CASE NUMBER, CASE
TITLE 02/01/2012 - 06/26/2018
FDA PERIPHERAL AND NERVOUS SYSTEM ADV COMMITTEE 8/11/10 MEETING
RECS
FDA LETTER CTS HEXASULFONATED OPTICAL BRIGHTENER AS COMPONENT
OF FOOD CONTACT PAPER ETC
Results from testing of pet food samples collected by
Department of Health and Human services FDA 971516 971515
ANDA 022000 091640 203286, etc
K101586
LIST OF FDA DRUGS FOR DEPRESSION
MEDICAL DEVICE ADVERSE EVENT REPORTS
FERRING GMBH, KIEL, GERMANY - 483 04/20/2008 - 05/20/2008
FERRING PRODUCTION, INC, PARSIPPANY, NJ - 483 09/01/2016 -
09/30/2016
FERRING PHARMACEUTICLAS, INC, PARSIPPANY, NJ - 483 09/15/2011 -
10/15/2011
GORDANA JOKSIC, BELGRADE, SERBIA RUZA ANTIC, BELGRADE, SERBIA
- EIRs
K172783
NYPRO, CLINTON, MA - 483 03/13/2017 - 03/17/2017
ANN SIMONEAU COMM RE SANTA FE NATURAL TOBACCO CO 08/24/2015 -
08/27/2015
ANDA 208363
LETTER FROM GAIL BORMEL TO EDWARD JOHN ALLERA ETC
LIST OF CLINICAL INVESTIGATORS INSPECTED ETC
Unredacted (document without redactions) traceback diagram for

FDA investigation of multistate outbreak of E. Coli O157:H7
infections linked to romaine lettuce from Yuma growing region
Food inspection reports for large facilities in the Houston
area
FDA study on flu vaccines' efficacy in seniors in the 2017-18
season
FERRING PHARMACEUTICALS, INC, PARSIPPANY, NJ - 483 10/01/2008 -
10/31/2008
K172787
1. Medical device recalls 2. Drug recalls 3. Historical list
of significantly regulated organizations (SRO) 4. Historical
list of medical device manufacturers registered with FDA
GAYLORD CHEMICAL COMPANY, LLC, TUSCALOOSA, AL - 483
ANDA 208363
JIANGZI FUSHINE PHARMACEUTICAL CO LTD, CHINA - EIR 06/22/2014 -
07/06/2014
FMD Form 142 for Celltrion's Incheon Plant 05/01/2018 -
07/02/2018
FERRING PHARMACEUTICALS, INC, PARSIPPANY, NJ - 483 05/15/2008 -
06/15/2008
DEN130051 K102651 K031831
MARIN BREAST HEALTH TRIAL CENTER, NOVATO, CA - INSPECTIONS
RECS, COMPLAINTS ETC
Review of published study reports pertaining to references
identified in OSEs 8/19/16, Pharmacovigilance Review on
Melanoma and PDE5 inhibitors
PACIRA RECALL RECS, COMMUNICATIONS ETC
ALKEM LABORATORIES LTD, DAMAN, INDIA - CLASSIFICATION RECS
03/01/2018 - 06/29/2018
K090288
K112786
FCN 1854
Copy of the disclosable portions of two documents mentioned on

page 4-5 of the Technical Project Lead Review for SE0002153
5/25/18 tentative approval letter for ANDA No. 209942
6/29/11 effective approval letter for ANDA No. 076619 for
Ifosfamide
CTP reviewer guides additions or updates from May 2016 to the

present to the Center for Tobacco Products Reviewer Guides,
Reviewer checklists, and Work instructions for review of
Substantial Equivalence Reports
INDIVIDUAL RECS
5/22/18 tentative approval letter for ANDA No. 210392 for
Tadalafil
K161355 K173085
2018-3725
HYDROCHLORIDE - AER 9/17 TO 12/17
ENTRY RC9-0028200-0
SODIUM GLUCOSE COTRANSPORTER INHIBITORS - AER 9/17 TO 12/17
CORR TO AND FROM REP JOHN FASO 1/17 TO 6/29/18
CASE 6:18-CV-613-GAP-DCI
FCN 1756
ALLERGAN - ONABOTULINUMTOXINA (BOTOX) IPSEN BIOPHARM LTD -
ABOBOTULINUMTOXINA (DYSPORT) MERZ NORTH AMERICA -
INCOBOTULINUMTOXINA (XEOMIN) - FAERS 2014 TO 2017
DR TAYFUR AYALP MD, FARMINGTON HILLS, MI - RECS
HP ACTHAR GEL (CORTICOTROPIN) - RLD
DCVAX-L PHASE III TRIAL SCREENING HALT
K092331CERTIFIED COPY 510(k) REVIEWER MEMO
DISEASE PREVALENCE ESTIMATES FOR PRODUCTS ON ODP APPS

GIFTS FDA COMM REC'D 05/11/2017 - 06/29/2018
K151296
TECHNICAL PROJECT LEAD REPORTS FOR NSE ISSUED TO DORSAL TOBACCO
OCT 2017-MAY2018
TECHNICAL PROJECT LEAD REPORTS AND REVIEWER NOTES FOR ANY SE
ORDERS ISSUED TO DOSAL TOBACCO OCT 2017- MAY2018
MICHAEL FEIGN, FRONT RANGE ORTHO, COLORADO SPRINGS, CO - WL
ETC.
SE ORDERS APRIL 2018 TECHNICAL PROJECT LEAD REPORTS AND
REVIEWER NOTES
XCALIBER OR TANTUS TOBACCO REVIEW RECS SE ORDERS MAY 10 AND
JUNE 8 2018
WILLIAM P WERSCHLER SPOKANE, WA - INSP RECS DATE RANGE:
11/06/2017 - 06/29/2018
K160942 SONABLATE
INSP RECS RELEASED SINCE 5/30/18
LIST OF INSP AND INSP CITATIONS 07/01/2017 - 07/01/2018
K173372
MEDICAL DEVICE ESTABLISHMENT REGISTRATION AND MEDICAL DEVICE
LISTING FILES, PRODUCT CODE CLASSIFICATION FILES
INSP LIST JUNE 2018
FOIA LOG JUNE 2018
RELEASED INSP RECS JUNE 2018
MEDWATCH REPORTS GARDASIL SEE ATTACHED LIST OF 76 CASES
MEDWATCH REPORTS GARDASIL 75 CASES SEE ATTACHED
LOG OF JUNE 2018 CLOSED REQUESTS FOR 483S
NDA CORTENEMA ANDA HYDROCORTISONE ENEMA RECTAL SUSP
K010911 SE LTR
MEDWATCH REPORTS GARDASIL 46 CASES SEE ATTACHED
K152115 RENEW
EVANGER'S DOG AND CAT FOOD CO, INC - RECALL RECS, ETC
06/01/2013 - PRESENT
483S SUN PHARM AUROBINDO PHARM CADILA PHARM INDIA - DATE:
04/01/2018 - 05/31/2018
K161212 FDA REVIEWS
YONSA NDA 210308 CLIN AND CMC REVIEW
LABELING PRIMACOR (NDA # 019436) (SUPPLEMENT NDA 19-436/S-
021)
COSYNTROPIN, SYNACTHEN AND ACTH COMMS WITH EXTERNAL PARTIES
SINCE 1/1/17
K181051 IMPEDE EMBOLIZATION PLUG
K140882
2018-1706 2017-4465 2017-4750 etc
PADE EIR JUNE 2012 ALKERMES, WALTHAM-MA
NEW FRENCH BAKERY, MN EIR 2017
PMA P000005 S005
K100742
K130387
K143374
K163127
K152764
K162800
K160555
K162567
K161789
REG OR VCRP RECS GUANGZHOU TIANZHILI BIO-TECHNOLOGY CO LTD.,
CHINA
NUPLAZID FAERS
Scott Gottlieb, Robert Califf, Margaret Hamburg etc - Emails
withd boyer@bgrdc.com, bwood@bgrdc.com, bdelmonte@bgrdc.com etc
01/01/2014 - 06/29/2018
Sorin Stockert 3T heater-cooler device AERS
Hospira Healthcare India Pvt. Ltd., Sriperumbudur India, Mylan

Laboratories Limited, Nashik District India, Choksi
Laboratories Limited, Indore India 483 04/01/2018 - 04/30/2018
Ruxolitinib ADR 8395844 8635043 8677746 etc
K170441 K103140 K143233 etc
SHIRAKAWA OLYMPUS CO LTD, JAPAN - EIR 05/18/2015 - 05/21/2015

GARDASIL CASE REPORTS
GARDASIL CASE REPORTS
FAERS 3023863, 9594515, 9909616, ETC
NDA 008362
OCALIVA AERS
K828673 K890147
"uly 31, 2013 memo from CDER/OMPQ/DIDQ/ICB" referenced in the
2013 Establishment Inspection Report (EIR) for the inspection
of Synthetics China Co., Ltd. (FEI 3006719713)
Sorin Stockert 3T heater-cooler device, infections caused by

and/or stemming from the use of the Sorin Stockert 3T heater-
cooler device in Amita Health Alexian Brothers Medical Center
etc
FOIA LOG 06/17/2018 - 06/30/2018
DMF SPREADSHEET
ANDA 209365 BIOEQUIVALENCE REVIEW
NDA 022320, Supplement 2 SBA
HOSPIRA HEALTHCARE INDIA PVT LTD, INDIA - 483 03/26/2018 -
04/03/2018
ZYDUS HOSPIRA ONCOLOGY LTD, INDIA - 483 04/09/2018 - 04/12/2018

SUN PHARMACEUTICAL INDUSTRIES LTD, INDIA - 483 04/16/2018 -
04/20/2018
MYLAN, GALWAY, IRELAND - 483, WARNING LETTER, CORR 06/01/2018
- 07/05/2018
ANDA 089804
ALGORITHME PHARMA USA, FARGO, ND - EIR 01/18/2017 - 01/20/2017

GARDASIL MEDWATCH REPORTS
K153027
RECS RE PREMARKET EVALUATION OF PURDUE PHARMA OXYCONTIN

483 RELEASED 06/01/2018 - 06/30/2018
NDA 209618
FOIA LOG 1/1/2017 TO PRESENT
FCN 1801
VM NUTRITIONAL, MURRAY, UT SUPRANATURALS, SPRINGVILLE, UT, ETC
- EIR 01/01/2011 - 07/06/2018
NDA 021536
NDA 012750
RECS RE FDA SOCIAL MEDIA LISTENING PLATFORM RE OPIOIDS
MEETING MINUTES MITCH ZELLER, EU DIRECTORATE GENERAL FOR HEALTH
AND FOOD SAFETY RE TOBACCO RELATED TOPICS 05/01/2018 -
07/02/2018
OCI INVESTIGATION MEMO
K160192
GARDASIL MEDWATCH REPORTS
K112711, K173542, K101749
CDC, INDIANA STATE DEPT OF HEALTH - EPIDEMIOLOGIC INVESTIGATION

GE Class 2 Recall Light Speed Computed Tomography Z-0802-2007
recall event ID 37007 510 K040372 etc
FDA Class 2 Recall date 11/19/2007 terminated 1/28/2013 Recall
# Z-2026-2012 event ID 62404 510 Ks K024012, K22069, K021049
etc
IND 51209
SERIOUS NUTRITION SOLUTIONS - RECS RE WARNING LETTER RECS RE
UNSENT WARNING LETTERS DIETARY SUPPLEMENTS
Dr. Yang Chai & Dr. Bridget Samuels University of Southern
California Center for Craniofacial Molecular Biology, Los
Angeles, CA - IDE, 510K, CLINICAL TRIALS ETC
INDIVIDUAL RECS
RECS RE FDAs POE INVESTIGATIONS FROM SOCIAL MEDIA PLATFORMS
RISE BAKING COMPANY, MINNEAPOLIS, MN - EIR 07/25/2016 -
08/26/2016
ADMA BIOLOGICS, BOCA RATON, FL - EIR APRIL 2018
K033660 FIRST PARTY
FULPHILA STUDY RECS
WILLIAM WERSCHLER, PREMIER CLINICAL RESEARCH, LLC, SPOKANE, WA

- 483, RESPONSE, WARNING LETTER ETC 11/29/2017 - 07/02/2018
TENTATIVELY APROVED ANDA - RVWS
Biotechnology Consultation BNF158 Submission, received by FDA
on Nov 14, 2016
Documents submitted to the Food and Drug Administration by
JUUL Labs, Inc. as part of FDA 04-2018 JUUL Request for
RD0000476
HERBALLY YOURS INC, ST GILBERT, AZ - INSPS, 483S, LIST OF
INGREDIENTS, ETC 6/28/13 TO RESENT
Records re validated analytical methods testing for the
presence of CBD and THC for all hemp products/ native raw
materials, from 2012 to present day
Airbus, Mobile, AL HAECO, Greensboro, NC etc - FDA Form 2371a

and 2371b "Certificate of Sanitary Construction," Form 483
OFFICE OF THE COMMISSIONER AND EXPRESS SCRIPTS HOLDING CO -
CORR 5/1/17 TO 6/26/18
OFFICE OF THE COMMISSIONER CORR REGARDING POLICY RELATED TO
PHARMACY BENEFIT MANAGERS 5/1/17 TO 6/26/18
(1) CTP Microbiology Guide after 2016 (2) CTP Toxicology Guide
(not provided in the 2017-3535) (3) Internal memo on ammonia
(mentioned on p.33 of the 04/01/2016 Chemistry Guide) etc
EIR RELEASED UNDER FOIA 06/01/2018 - 06/30/2018
MEAD JOHNSON INFANT FORMULA INVESTIGATION RECS FOIA REQUESTS
01/01/2015 - 07/03/2018
INDIVIDUAL RECS
SHANGHAI DESANO CHEMICAL PHARMACEUTICALS - 483 08/02/2009 -
03/02/2018
SPREADSHEET OF INSPECTION CLASSIFICATIONS 10/01/2011 -
06/30/2018
ENFORCEMENT REPORTS 10/01/2011 - 07/03/2018
Copies of all drafted, submitted or received SF-716 forms
produced from January 1, 2001 through December 31, 2017
INSPECTION DATA 04/01/2018 - 06/30/2018
K892886 K905234 K905235 ETC
WEIS MARKETS, ICE CREAM DIVISION, SUNBURY, PA WEIS MARKETS
MEAT PLANT, SUNBURY, PA ETC - INSPECTION RECS, CORR 09/04/2009
- 07/03/2018
AKORN, DECATUR, IL - 483 02/01/2018 - 07/02/2018
LOG OF FOIA REQUESTS FOIA CLOSED 7A EXEMPTIONS 06/01/2018 -
06/30/2018
RECS OF IMPORTATION OF VITAMINS, MINERALS, ETC FOR USE IN PET
BIRD FOOD BY ZUPREEM, HIGGINS PREMIUM PET FOOD, LAFEBER
COMPANY 01/04/2016 - 12/31/2017
INSPECTION DATA 05/01/2018 - 06/30/2018
LETITIA ROBINSON, INDIA DIRECTOR - PRICE OF FLIGHTS, HOTELS
COMMUNICATIONS BETWEEN PERCHOLORATE USERS ETC RE FDA ACTION
THRESHOLD OF REGULATION EXEMPTION TOR No. 2005-006 01/01/2013
- 06/30/2018
KEYTRUDA SUPP APPLICATION
RECS RE UNREBUTTED EVIDENCE THAT FDA DECISIONS STEMMED FROM
POLITICAL PRESSURE
FOIA LOG 03/15/2018 - 07/05/2018
DR SCOTT GOTTLIEB CALENDAR 03/15/2018 - 07/05/2018
K081565 FIRST PARTY
AIZANT DRUG RESEARCH SOLUTIONS PVT LTD, INDIA - EIR UNREDACTED
08/14/2017 - 08/18/2017
JUDGE ROTENBERG EDUCATIONAL CENTER INC - INSPS 1/31/00 TO
2/10/00 483 11/23/2010 WARNING LTR 12/7/12, ETC
2017-10625
INDIVIDUAL RECS
HYDROPROGESTERONE CAPROATE ANDA 210-723 APRVL LTR 6/21/18
DRUG COMPANIES, MEDICAL DVC MFRS, BLOOD ESTABLISHMENTS, ETC -
DOMESTIC AND FOREIGN INSPS 4/1/18 TO 6/30/18
SNYDER'S LANCE INC, CHARLOTTE, NC ETC - 483 02/13/2017 -
05/04/2018
CHRISTOPHER RANCH LLC, GILROY, CA ETC - 483 05/23/2016 -
10/20/2017
MEDTRONIC PEURTO RICO OPERATIONS CO, JUNCOS, PR ETC - 483
04/19/2017 - 06/01/2018
CPT1800464BY
K170507
DEXTENZA APPROVAL RECS
ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD, CHINA - 483 11/01/2016 -
12/31/2016
COMPLAINT 152080
SUNSCREEN PRODUCTS REPORTS, BIOLOGIC SAFETY REPORTS 01/01/2008
- 07/06/2018
K123672
K110124, K131457, K140582, ETC
Historical/inactive and currently active NDC codes that FDA
received till date
K063859
ANDA 088131, 088133, 088134 CMC RECS
NDA 010418
Recs re "Summary and Comments on Analyses for Asbestos in
Cosmetic Talc Products" by Heinz J. Biermann, dated October 1,
1973
JIM BRADY'S RESTAURANT, NEW YORK, NY - INSPECTION RECS
07/06/1998 - 07/09/2018
NDA 020193
NASCOBAL CONSUMER COMPLAINTS 01/01/2005 - 01/20/2018
DINESH GUPTA, TENNESSEE CENTER FOR CLINICAL TRIALS, TULLAHOMA,
TN - 483 01/01/2018 - 07/06/2018
CORR BETWEEN FDA AND JUUL LABS 06/01/2015 - 07/09/2018
K962985
RECS RE ERIC POTRATZ, PRIMORDIAL PERFORMANCE
BEST MAID COOKIE, RIVER FALLS, MN - EIR 11/01/2016 - 11/30/2016

HYDROCHLOROTHIAZIE TABLETS AERS
DEN170089
K971794 FIRST PARTY
NOVELTY CONE COMPANY, INC, PENNSAUKEN, NJ ETC 483 08/29/2016 -
06/14/2018
MILLER'S HONEY COMPANY INC, SALT TAKE CITY, UT ETC - 483
07/10/2017 - 03/01/2018
K123999
WUXI APPTEC BIOPHARMACEUTICALS - 483 8/2/17
CATALLIA MEDIXICAN FOODS, LLC, EAGAN, MN ETC - 483 11/01/2017
- 03/14/2018
RACHEL M PRESTI, SAINT LOUIS, MO ETC 483 06/06/2016 -
03/13/2018
SE0006283
List of 483s issued in June 2018
RICHARD WOLF MEDICAL INSTRUMENT CORPORATION, VERNON HILLS, IL -
EIR 03/25/2013 - 06/04/2015
K162515
K103529 INSTRUCTIONS FOR US
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION, VERNON HILLS, IL
- EIR 3/25/13
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION, VERNON HILLS, IL
- 09/17/2014 - 10/10/2014
OTC Volumes 160363 and 160390 submitted to Docket No 82N-0214

NDA 1-504
FAIRVIEW COMPOUNDING PHARMACY, MINNEAPOLIS, MN - EIR
04/02/2018 - 04/18/2018
FSVP RECS GLENDALE WAREHOUSE & DISTRIBUTION CORP ETC
K950709
NDA 020553
FCN 574
FCN 958
SOUTH FORK DAIRY, LLC, EVAN BARTON, NEWARK, OH - INSPECTIONS,
COMPLAINTS
NESTLE USA DBA NESTLE PROFESSIONAL LJ MINOR, BRECKSVILLE, OH
ETC 483 10/23/2017 - 04/03/2018
ANDA 203649
ASTELLAS PHARMA US, NORTHBROOK, IL ETC 483 07/12/2001 -
05/16/2018
FCN 1346 FCN 71 ETC
PINNACLE FOODS GROUP INC, JACKSON, TN ETC 483 02/08/2000 -
01/23/2018
HANOVER FOODS CORPORATION, RIDGELY, MD ETC 483 03/20/2017 -
04/12/2018
BAXALTA US INC, THOUSAND OAKS, CA ETC 483 08/12/2015 -
01/19/2018
KELLOGG HONEY SMACKS LAB RESULTS, 484, EIR ETC 01/01/2018 -
07/05/2018
GILL DAIRY, LLC, TONY GILL, FRANK GENUTGEN, SOUTH SOLON, OH -
483, COMPLAINT ETC 01/01/2008 - 07/05/2018
KATE'S HOMEMADE BUTTER INC, ARUNDEL, ME ETC 483 10/24/2017 -
04/05/2018
K150465 K181001 REVIEWER NOTES
2016-10529 CERTIFIED
SOUTH FORK DAIRY, LLC, EVAN BARTON, NEWARK, OH - 483,
COMPLAINTS ETC 01/01/2008 - 07/05/2018
NDA 02153
ANSWER TO TEST FD249 CONDUCTING SEAFOOD INSPECTION COURSE
10/18/2010 - 04/07/2017
KRATOM TESTS REFERENCED IN STATEMENT
LL'S MAGNETIC CLAY INC - COMMUNICATIONS 06/01/2018 - 08/31/2018

K172079
FDA-ORA-MP-10169794
GRUMA CORPORATION DBA MISSION FOODS, PUEBLO, CO - 483
03/19/2010 - 06/17/2015
MEDICAL DEVICE CLEARANCE
INDIVIDUAL RECS 02/01/2012 - 07/06/2018
BIORERLIANCE CORPORATION, ROCKVILLE, MD - 483, EIR 10/01/2014 -
04/17/2018
COUNTRY FRESH, INC, HOUSTON, TX ETC - INSPECTION RECS
01/01/2013 - 07/06/2018
EMAILS, SAMPLES 03/26/2015 - 08/31/2015
K082891
SE0006288
SE0000116
RICHARDSON-VICKS/PROCTOR GAMBLE, GREENSBORO, NC - 483
01/01/1980 - 12/31/1985
SE0000117
SE0000118
SE0014069
SE0006276
BENEDICT S LIAO EMAILS, INSPECTIONS, WEST COVINA, CA
07/06/2014 - 07/09/2018
SE0014068
K131467
K828673
HUDSON BAKING COMPANY, HUDSON, WI - EIR 01/01/2017 - 01/14/2017

SE0006284
SE0006282
SE0006281
EX0000219
SE0006280
K924165
SE0006278
SE0006277
SE0006279
K150754
SE0014486
SE0014485
SE0002191
SE0014484
SE0014483
SE0002190
SE0006289
K061180K011841K01034 ETC
NDA 201587
NDA 206977
K150754
KOMBUCHA - MFG PROCESSES, STANDARD OF IDENTITY, CONSUMER
CMPLNTS, ETC
SUEZ WTS USA INC - FCN 1548
ENTRY RD8-0022132-0 ANALYTICAL PACKAGE
AMERICAN MEDICAL ELECTRONICS (ORTHOFIX) - P850007/S006,S013
PHILIP HEALTHCARE - INGENIA 3T MRI K110151, K173079, K177356,
ETC 483S, RECALLS, CMPLNTS, ETC
JAVO BEVERAGE COMPANY INC - EIRS, 483S, TESTING, ETC
STRIDES PAHRMA GLOBAL PTE LTD - KETOCONAZOLE TABS ANDA 210-457
SBA
2018-5300
LENNY & LARRY'S COOKIE RECALL RECS - COMM, TESTING, ETC
07/01/2016 - 12/31/2016
NUPLAZID ETC AERS
NDA 050703 SBA
Inactivated DMF's 16167, 16168, and 16169
2017-1967 2017-4694 2017-6766 2017-7099 2017-7127 2017-7128
2017-7773 2018-2605 2018-2608 2018-2968
Orphan drug designation letter decision and orphan drug

designation package for the following three molecules: 1. 6-
{(1S)-1-phenylethylamino}-3-(propan-2-yl)-1,2,3,4
tetrahydropyrimidine-2,4-dione for the treatment of symptomatic
obstructive hypertrop
Most recent sales data in kilograms for the following
antibiotics: amoxicillin, doxycycline, cephalexin,
ciprofloxacin
RECS RE SCOTT GOTTLIEB SENIOR ADVISOR FOR FDA, INSIGHT ON HOUSE

LABORATORY TESTING APPROVAL KITS 01/01/2003 - 12/31/2007
FAIRLIFE, LLC, COOPERSVILLE, MI - REPORTS, CITATIONS ETC RE
TESTING OF MILK
UNITED SAFETY AGENTS - RECS CONTAINING DUNS NUMBER ETC
07/09/2018 - 07/31/2018
FOIA LOGS EXCEL FORMAT 06/20/2018 - 07/10/2018
CONTINENTAL DAIRY FACILITIES, LLC, COOPERSVILLE, MI - REPORTS,
PERMITS ETC RE MILK PRODUCT TRANSPORTATION 01/01/2012 -
07/10/2018
RECS RE TALC, 2015-8567
K014274
CSL PLASMA INC, OMAHA, NE - EIR 06/01/2017 - 06/30/2017
Recs re synthesis and manufacturing of the API for the drug
Synthroid (LEVOTHYROXINE SODIUM) oral tablet
LIVANOVA PLC, HOUSTON, TX 01/01/2016 -05/29/2018 LIVANOVA PLC,
MUNICH, GERMANY 01/01/2016 - 05/29/2018 LIVANOVA PLC, ARVADA,
CO 01/01/2016 - 05/29/2018 ETC EIR, 483
Correspondence between the FDA and MARS PETCARE US, INC in
Columbus, OH between July 2017 and July 2018
DRAXXIN ENVIRONMENTAL ASSESSMENT
PCS 300 PLASMA COLLECTION 510K
ABBOTT MITRACLIP DETAILED NARRATIVE MAUDE RECS 01/01/2013 -
07/10/2018
GARAGE VIDEO
FSVP spreadsheet which includes the 23 publicly available data
points for all entries that led to our company's inclusion in
this list
FAIR OAKS BRAND, INC, FAIRLIFE, LLC, SELECT MILK PRODUCERS, INC
- REPORTS, RECS, LICENSES ETC TRANSPORTATION OF MILK INTO STATE
OF MICHIGAN 01/01/2012 - 07/10/2018
K132833
K014274
LEPRO HERBALS PVT LTD, PANIPAT, INDIA CORR ETC 01/01/2015 -
06/30/2016
NDA 017247
BK170108
NDA 020220
K052293
DAEWOONG PHARMACEUTICAL CO LTD, SOUTH KOREA - EIR 11/01/2017 -
11/30/2017
ANDA 210457 SBA
UNITED STATES V KRISTJAN THORKELSON, CANADADRUGS.COM LTD
PARTNERSHIP ET AL ELI LILLY AND TAKDEDA PHARMACEUTICALS USA
INC - ILLEGAL IMPORTATION AND MISBRANDING OF PRESCRIPTION DRUGS
DERMIRA INC - QBREXZA (GLYCOPYRRONIUM) NDA 210-361 SBA
Food Contact Notification #1665
INTERNATIONAL LABORATORIES LLC - CLOPIDOGREL TABS RECALLRECS

JUUL LABS INC - RD000476 TOBACCO PRODUCTS DEVELOPMENT, TEST
MARKETING, RESEARCH, ETC
JAMIESON - FORM FDA 3500, FORMA FDA 3500A, FDA FORM 3500B
REFUSE TO FILE RESPS ISSUED TO SPONSORS IN RESPONSE NDA, BLA,
SNDA, SBLA CORR 1/1/17 TO 7/6/18
Clinical research organizations in China that have been

utilized by a sponsor to submit clinical trial data from
clinical trials performed in China (the "Data"), to the U.S.
FDA and the U.S. FDA has accepted this Data to support
advancing a product (dr
VITALITY WORKS INC, ALBUQUERQUE, NM - INSPS, 483S, INGREDIENTS,
ETC 7/6/13 TO PRESENT
Recs res updates to the FDA's public communications policies
from January 1, 2018 to today, July 2, 2018
Waiora International Ltd. Dietary Supplement: NCD2 AERS
CIGARETTE MANUFACTURER BRAND STYLES, ABBREVIATED LIST OF
HARMFUL AND POTENTIALLY HARMFUL CONSTITUENTS
RECEIPT FOR BOOTH COST AT AMERICA'S FAMILY PET EXPO
Food Contact Notification #1421
REQUEST LTRS, DENIALS 6/18
PLAVIL, MELATONIN - RECS
RECS RE ROADRUNNER ANADA APOQUEL
Response to request under correspondence from Review Division

Dated April 17, 2013 in the OOPD Database, which is referenced
on Page 2 of the attached May 1, 2013 Orphan Exclusivity
Memorandum for Ravicti
CADILA, HOSPIRA JOINT VENTURE, INDIA - 483 04/01/2018 -
04/30/2018
HISTORICAL DATA DRUG ZIP FILES 01/01/1984 - 12/31/2016
K063049
TITLE LIST OF INTELLIGENCE BULLETINS NATIONAL INSTITUTE FOR
OCCUPATIONAL SAFETY AND HEALTH (NIOSH) FOIA LOGS
UNITED CATERING OPERATIONS, HOUSTON, TX - HEALTH AND FOOD
SAFETY INSP RPTS 1/1/16 TO PRESENT
HALOPERIDOL - RECS
BIOVET JSC, BULARGIA - EIR 06/19/2017 - 06/23/2017
HALOPERIDOL 10MG TABS - RECS
AKORN INC INSPECTION RECS 05/01/2018 - 07/03/2018
RADAGAST PET FOOD, INC - RECALL TESTING RECS 01/01/2018 -
04/20/2018
OC Raw Dog, LLC - Recall Testing Recs 01/01/2018 - 05/01/2018
K030310
TDaP lot # ED2EN AERS
NDA 018956
Berkshire Sterile Manufacturing, Inc., Lee, MA etc - 483
HETERO UNIT I, INDIA - 483 02/26/2018 - 03/02/2018
CPT1700867
INFLECTRA, RENFLEXIS, REMICADE RECS RE APPROVED SHELF LIFE,
REVISIONS
RECS PRODUCED BY JUUL LABS RE RD0000476 04/28/2018 - 07/12/2018

RECS RE REVIEW OF 15 XCALIBER INTERNATIONAL PRODUCTS
BLUE RIDGE BEEF OF EATONTON, GA - RECALL TESTING RECS
01/01/2018 - 03/26/2018
NNC12IA11I
Copy of the disclosable portions of the letter dated 03/18/1999
from Alan Bennett to FDA regarding orphan drug exclusivity for
interferon-beta products
CPT1700887
SHANGHAI MEDICILON INC, CHINA - EIR, 483, RESPONSE
HHSF223201750056A
K040836
K052084
CELLTRION INCHEON, SOUTH KOREA - 483 STATUS, CORR 05/20/2017 -
01/17/2018
TRUPET RECALL TESTING RECS 01/01/2018 - 04/17/2018
HHSF2232016100048 HHSF22316001
K122270
NDA 020532
K173595
NADA 100-237
K163510
ANADA 200-248 NADA 100-237
K180606 SUMMARY
DEN130015 K142801 K160338 K163507
LUPANETA PACK NDA 203696
Recs re United States ex rel. Campie v. Gilead Sciences, Inc.
Communications with CMS re Gilead compliance
RAD CAT PET RAW DIET FREE-RANGE CHICKEN RECALL TESTING RECS
01/01/2018 - 03/20/2018
FSVP RECS RE WEGMAN'S 03/17/2018 - 07/11/2018
F & I COHEN INC, WINNETKA, CA - NOTICES OF VIOLATIONS,
CITATIONS, INSP SHEETS, ETC
INDIVIDUAL RECS
DRUG RECALLS 2011-2016

K063091 K130943
K083641
COMPLIANCE ACTIONS DATA 01/01/1994 - 07/15/2018
2018-21
K062282
MEDIVATIVE TECHNOLOGIES, INDIANAPOLIS, IN - 483 01/01/2014 -
01/01/2018
ALLERGAN, INC, IRVINE, CA - EIR 01/01/1999 - 12/31/2001
ORAJEL TEETHING PRODUCTS, COMMUNICATIONS WITH CHURCH & DWIGHT
RE TEETHING PRODUCTS 01/01/2005 - 07/16/2018
DEN180001
Sample #1024062
ADMA BIOLOGICS, INC, RAMSEY, NJ BOCA RATON, FL -
COMMUNICATIONS WITH FDA 01/01/2018 - 07/13/2018
K170840
K132951
NDA 207533/S4 06/05/2017 APPROVAL
NDA 020449
DEN170001
K180394
K153281
513(g) submissions
513(g) submissions and FDAs responses, for the companies
Hologenix, Holofiber, and Celliant
PRISHA COSMETICS, RIKEN SHAH, PRITI SHAN, CHATSWORTH, CA -
INSPECTIONS, WARNING LETTERS ETC 01/01/2010 - 07/13/2018
Hudson CONCHATHERM III+ HEATER,21 VOLT Catalog #380-88R AERS

ANDA 207550
RAW BASICS LLC, PLEASANT PRAIRIE, WI - RECALL RECS 01/01/2018 -
03/06/2018
MEGAFINE, INDIA - 483 01/01/2018 - 07/13/2018

2017-10410
KAYEXALATE AERS
ANDA 75172
ANDA 74171
ANDA 040066
SHANDONG ZOUPING DAZHAN NEW MATERIALS CO LTD, CHINA - 483
1.12.18
Travel records for Dan McChesney for the month of September
2017
2015-8495 2016-3421 2016-3462 ETC
EMAIL BETWEEN DAN MCCHESNEY AND CHRISTOPHER COWELL 01/01/2017
- 07/31/2017
POLARITYTE SKINTE HCT/P CORR WITH FDA 01/01/2017 - 07/16/2018

CPT 1800586
GOLD KOSHER CATERING, MIAMI, FL - INSPECTION RECS 01/01/2015 -
12/31/2017
BLA 125409 S113, 118
APOTHECON - KENALOG-40 INJ (TRIAMCINOLONE ACETONIDE INJECTABLE
SUSPENSION) NDA 14-901 LBLG
CLOSEED LOG 6/25-29/18
DAIL LOG 6/18-22/18
ADVIL LIQUI-GELS SBA, SUMMARY REIVEW, CMC ETC
K133532
Public Warning Letter issued in July 2008 for the use of
Medtronics Infuse BMP
THERANOS RECS RE PRODUCT APPROVALS, EMAILS
ZHEJIANG PHARMACEUTICALS CO LTD, CHINA - 483 01/19/2018 -
01/29/2018
ZHEJIANG CHANGHAI PHARMACEUTICALS CO LTD, CHINA - 483
01/19/2018 - 01/30/2018
APOTEK PRODUKTION & LABORATORIER AB, SWEDEN - 483 05/24/2018 -
06/05/2018
BUPRENORPHINE SBA
CLIA WAIVER APPLICATION K091216
GILSTER-MARY LEE CORPORATION, PERRYVILLE, MO - 483, 483, EIR
ETC
K161469
Adverse event reports with patiromer
QVAR, ARMONAIR RESPI CLICK ETC FAERs
MYLAN, NASHIK, INDIA - 483 02/01/2018 - 05/31/2018
Medical Review(s) of BLA 125554 (nivolumab) for the following
supplements (dose change): S-048, S-049, S-050, S-051,S-052,
S-061, S-062, S-064, S-065, and S-066
All records related to Consumer Complaint 152312
ZIMMER MANUFACTURING BV MERCEDITA PUERTO RICO - 483 07/01/2017
- 07/31/2017
COVIDIENT, MEDTRONIC RECS SUBMITTED RE LIGASURE 01/01/2010 -
12/31/2017
FOIA LOG 01/01/2015 - 12/31/2015
CPT1800518
2018-1933
K040980
STN RD0000476 JUUL SUBMISSION RECS
RECS RE NCAR AND IMDRF
K061615 K110715
Administrative documents associated with the approval of
Sublocade
GRAS 784
K171050
FRESH PAK, INC, DETROIT, MI ETC 483 01/04/2018 - 05/15/2018
NDA 007959/S-015 APPROVAL LETTER, LABELING
ICON LABORATORY SERVICES, INC, WHITESBORO, NY ETC 483
02/28/2012 - 02/08/2018
ASTRAZENECA PHARMACEUTICALS. NEWARK, DE ETC 483 03/14/2016 -
08/24/2017
K141789
CARLOS DANGER, MD, MIAMI, FL ETC 483 08/17/2015 - 04/24/2018

TOXIKON CORP, BEDFORD, MA ETC 483 04/25/2016 - 05/04/2018
RA MEDICAL SYSTEM, CARLSBAD, CA - 483 04/01/2018 - 07/17/2018

RECS RE DOSES, DURATION OF FLUOROQUINOLONE USE
A copy of any and all Notifications submitted pursuant to
Section 412(d)(1) of the FFDCA for Prolact Plus Human Milk
Fortifiers (+4, +6, +8, and +10)
Communications, inspection reports, laboratory reports,

consumer complaints, agreements, and memorandums of
understanding related to the 2018 recall of Smucker Pet Foods
and the 2017 recall of Evanger's Pet Foods
Requesting RLD Labeling Materials: Package Insert, Container

Label, Carton and Medication Guide for Xylocaine (NDA 008048)
Entries for which Gusmer Enterprises was declared as the FSVP
importer
K102531
FDA Review Package for SUPPL-11 of NDA 022363 (approved on
11/18/2016), Livalo (pitavastatin) tablets 1 mg, 2 mg, 4 mg
ABBOTT DIABETES CARE, ALAMEDA, CA - 483, NOTES 09/01/2017 -
01/17/2018
NDA 12-142/S-107
Scientific and/or policy memorandum for bOPN. Synonyms: bovine

osteopontin scientific memo scientific memo component of GRN
000716 policy memo. All scientific and/or policy memoranda
related to FDA's evaluation of GRN 000716 and/or the intended
use o
All documents concerning Exogenous Ketones (also called dietary
ketones, ketone esters, and/or ketone salts) that have been
composed, created, produced, sent, or received, between the
dates of January 1st, 2013 and July 15th,, 2018
All memos, draft memos and other documents authored by Daniel
Fabricant concerning OxyElite Pro or USPLabs 01/01/2012 -
01/01/2016
Correspondence between Dr. Steve Miller, chief medical officer

of Express Scripts, and the FDA Office of the Commissioner
ANDA 040745
GARDASIL SAFETY STUDY RECS
1 specific monthly Orange Book Cumulative Supplements from the
20092018 period
Medical Review (s) for BLA 125554 (nivolumab), supplement: S-
041
AERS NUPLAZID, PIMAVANSERIN
ORTHOSENSOR INC, DANIA BEACH, FL - EIR 01/13/2016 - 01/15/2016

K163453
Iopamidol (Isovue) approval package for non-clinical areas, ie

pharmacology (safety pharmacology), pharmacokinetics &
toxicology (acute dose, repeat dose (NOEL, NOAEL, LOAEL)
K131553 K131103 K984233
HAUPT PHARMA LATINA 483 04/01/2018 - 07/17/2018
BLA 125031 / S-180
NDA 016949
BLA 103362
ETC MAUDE REPORTS
180-Day PMA supplement file P030036/S100
K172111 K160880
OCEAN BLUE LOGISTICS, ORLANDO, FL - EIR, 483 01/02/2013 -
01/13/2018
AMERISOURCE BERGAN, CHESTERBROOK, PA, LAKE FOREST, IL, ETC
01/01/2013 - 12/31/2017
All transcripts, summaries, slide decks and related materials

from a February 2018 Critical Path Innovation Meeting on the
topic of "Translational Pharmaceutics based drug development in
the US."
2018-3876
copy of the FDA FOIA log for the time period June 1, 2018 to
June 30, 2018, where information was requested concerning
Prilosec and/or Nexium
Grant 1U01FD005291 Grant 1U01FD005288 Contract
HHSF223201610114C
K173084
RECS RE GLYPHOSATE AND VACCINES
AIRON CORPORATION, MELBOURNE, FL - EIR 01/11/2017 - 01/31/2017
2018-1507 2017-10671
NDA 022406
OSB Lead-OBERA PAS (OPAS-001) for the ORBERA Intragastric
Balloon System - PROTOCOLS, REPORTS (CERTIFIED)
Wakefern-NJ WAKEFERN-PA Wake Fern Food-NJ Wakefern Food Corp-NJ
Wakefern Food Corp.-NJ ETC FSVP
INDIVIDUAL RECS
CRYODOSE TA OTC MIST SPRAY K172203
ABBOTT LABS - HUMIRA (ADALIMUMAB INJ) RECALLS, LAWSUITS, AERS,
ETC
LAP-BAND ADJUSTABLE GASTRIC BANDING SYS P00008 ANNUAL RPTS,
APRVL RECS, SUMMARIES, ETC
SAN SABA PECAN LP, GOLDEN PEANUT COMPANY LLC - CORR,
COMPLIANCE, APRVLS, ETC
PAXIL - INDIVIDUAL RECS
ALCOHOL - LIMIT TO SALES
PERMIT TO IMPORT ABACAUR TABS, LAMIVUDINA TABS, TRAYENTA TABS,
ETC
SPARK THERAPEUTICS, WEST PHILADELPHIA, PA KITE PHARMA, EL

SEGUNDO, CA NOVARTIS, MORRIS PLAINS, NJ - 483S 3/18 TO PRESENT
RECS RE NDA 022222, 022494, 022510, ETC

CORR BETWEEN SCOTT GOTTLIEB AND MEDIA STAFF RE TWEETS
05/09/2017 - 01/17/2018
MERCK - GARDASIL VACCINE STUDIES, CLNCL TRIALS, CMPLNTS, ETC

SEROQUEL, RISPERDAL, GEODON, ETC - TESTING, DRUG TRIALS,
RESEARCH NOTES, ETC
BUDESONIDE ANDA 205-4457 - APRVL LTR 7/3/18
NORTRIPTYLINE - SHORT AND LONG TERM EFFECTS, REACTIONS WITH
OTHER DRUGS AGENCY MANUAL
2016-6520 2016-10027 2017-3773 etc
DAEWOONG PHARMACEUTICAL, SOUTH KOREA - EIR 01/01/2018 -
07/18/2018
K163696
K160862
DATA PROVIDED BY JUUL
COMPOUNDING CENTERS OF AMERICA, HOUSTON, TX - CONSUMER
COMPLAINTS, ETC
K013093
K092003
NXSTAGE MEDICAL INC, TIJUANA, MEXICO - 483, ETC 01/02/2017 -
07/17/2018
GUARDIAN PHARMACY SERVICES, DALLAS, TX - CONSUMER COMPLAINTS
ETC
FDA Enforcement report from March 17, 1999
K093633
Communications between FDA and AbbVie and/or Biogen relating to
Zinbryta (daclizumab)
FDA-1980-N-0074, FDA-1980-N-0074-0001/CP
All documentation related to FDA's internal review of the 2009

Citizen Petition submitted by The Proctor & Gamble Company
(FDA-1980-N-0074-0001/CP) which requested an allowance for the
use of the in vitro pH cycling model, on an individual case
basis,
All information requests issued by the Center for Tobacco
Products pursuant to Section 904(b) of the Federal, Food, Drug,
and Cosmetic Act
All records and correspondence related to an email from

Joelle.Lester@mitchellhamline.edu to
Mitchell.Zeller@fda.hhs.gov and Ann.Simoneau@fda.hhs.gov, with
the subject line "New Product without Marketing Orders,"
including correspondence within the FDA
FLUOCINONIDE REGISTRATION RECS
All responses to Section 904(b) information requests issued

by the Center for Tobacco Product to JUUL Labs Inc., J Well
(and MMS ECVD LLC), Liquid Filling Solutions LLC (and Myle Vape
Inc), SVR Inc., and YGT Investment LLC, and 7 Daze LLC
NDA 205004 Supplement 2
HHSF223201810000B
HHSF223201810000B
Speaker presentations (including presentations from the Open
Public Hearing if available) from the July 17, 2018 CBER Blood
Products Advisory Committee Meeting
Tobacco related product injury/adverse event/reaction reports

voluntarily reported to the FDA Center for Tobacco Products,
the FDA Safety Reporting Portal, MedWatch program, and the FDA
Adverse Event Reporting System from January 2017 - June 2018
NDA 018692
FDA records related to the Grade 5 Serious Adverse Event
(patient death) during the Phase 1 study of Mersana
Therapeutics' drug XMT-1522
Protein Research 1852 Rutan Dr, Livermore, CA 94551
Establishment Inspection Report (EIR) Form 483
K042613
K923402
BOSTON SCIENTIFIC, RESEARCH AND TECHNOLOGY CENTER, ARDEN HILLS,
MN - 483 ETC 06/01/2018 - 06/18/2018
Recs re doses and duration of fluoroquinolone use that led to
the recent changes in drug class labeling
A list of all sites where the FDA conducted GMP, GLP or GCP
inspections during the requested period
INDIVIDUAL RECS 10/20/2017 - 04/20/2018
3M COMPANY IRB, SAINT PAUL, MN - EIR, 483, CORR 4/14/17
3D IMAGING DRUG DESIGN AND DEVELOPMENT, LITTLE ROCK, AR - EIR,
483, CORR 4/20/17
NDA 006488, Supplement 27
2018-1160 2018-1784
SE0014246
SE0014221
ANDA 207989
E-mail records for Miriam.Burbach@fda.hhs.gov for the dates
07.01.18 through 07.18.18
E-mail records for katie.alford@fda.hhs.gov for the dates
07.01.18 through 07.18.18
3M DELIVERY SYSTEMS, NORTHRIDGE, CA - EIR, 483, CORR 3/6/17
MATTHEW TAYLOR, OREGON HEALTH AND SCIENCE UNIVERSITY, PORTALND,
OR - EIR, 483, CORR 8/26/16
3/17/16 WASHINGTON UNIVERSITY SCHOOL OF MEDICINE, ST LOUIS, MO
- EIR, 483, CORR 03/17/2016 - 04/01/2016
GENEWIZ, LLC, SOUTH PLAINFIELD, NJ - EIR, 483, CORR 3/31/15
STRIDES SHASUM LIMITED, INDIA - 483 5/26/17
21ST CENTURY SCIENTIFIC, COEUR D'ALENE, ID - EIR, 483, CORR
3/21/17
JINAD 012-532, submission ID# 0007, dated May 13, 2015
NDA 050505
NITROGLYCERIN APPLICATION RECS
CORR BETWEEN CDER AND PHILADELPHIA DISTRICT RE HYDROXYZINE
HCl, BY KVK TECH 01/01/2006 TO PRESENT
K101052 FIRST PARTY
CORR BETWEEN FDA AND FTC RE ANTICOMPETITIVE BEHAVIOR OF BRANDED

AND GENERIC PHARMACEUTICAL COMPANIES 03/01/2017 - 12/31/2018
Coltne/Whaledent GmbH + Co. KG, Germany EIR 2016
K063148
REPORTS RE VAPE BATTERY EXPLOSIONS 01/01/2015 - 07/19/2018
LIST OF OVERSEAS AND DOMESTIC COMPANIES REGISTERED WITH THE FDA
TO SELL BABY FORMULA IN THE USA
MODULATED IMAGING INC - K181623
2018-5313
CAERS 01/01/2004 - 07/16/2018
INDIVIDUAL RECS
SCOTT GOTTLIEB CONFLICT OF INTEREST DISCLOSURES 01/01/2003 -
07/16/2018
NICOLA CARMICHAEL'S WARRANT OF AUTHORITY
ENTRY NO RD8-0022134-6 - ANALYTICAL PACKAGE
ENTRY NO RD8-0022135-3 - ANALYTICAL PACKAGE
ANI PHARMACEUTICALS - PROPAFENONE HCLTABS ANDA 76-550 PRAZOSIN
CAPS ANDA 72-577 CORR, RVWS, BIOEQUV
DEL MONTE FRESH PRODUCE NA INC - RECALL OF VEGETABLE TRAYS
CONNECTED TO RECENT CYCLOSPORA-RELATED ILLNESSES
OXCARBAZEPINE NDA 05-444 APRVL
NDA019708/S-026
NDA019699/S-026
NDA018900/S-034
RAW ATER, LIVE WATER, GROUND WATER - RPTS, MEMOS, POLICIES, ETC
1/17 TO 1/18
K170574
K170595
K171584
NDA018156/S-031
NDA020002/S-023
NDA019873/S-027
ANDA 208790
NDA019633/S-034
NDA202106/S-003
NDA019635/S-044
ALLERGAN INC - RHOFADE (OXYMETAZOLINE HCL) NDA 208-552 SBA,
MOR, LBLG, ETC
NDA019632/S-039
NDA019630/S-043
NDA019634/S-039
NDA019634/S-039
NDA019696/S-035
NDA019711/S-034
NDA019630/S-042
NDA016730/S-055
NDA017464/S-050
NDA019873/S-028
2017-1246
NDA019626/S-035
NDA018900/S-033
K170897
NDA018681/0028
ANDA A209133
NDA019634/0037
NDA019632/0037
NDA019630/S-044
NDA019631/S-038
NDA019633/S-035
DIPRIVAN MEDWATACH REPORT
LUPIN LIMITED, INDIA - RESPONSE TO 483 05/19/2017 - 12/22/2017

COURSE MANUAL FOR MILK PASTEURIZATION
NDA019634/S-040
NDA019635/S-045
NDA019696/S-036
NDA019699/S-028
NDA019708/S-028
NDA019711/S-035
NDA019826/S-029
NDA019830/S-023
NDA019952/S-037
NDA019953/S-035
TAULER SMITH LLP - EMAILS, MEMOS, INTERVIEWS, ETC 1/15 TO 10/17

NDA020002/S-024
NDA020006/S-024
TESTING RECS REDBARN, LONG BEACH, CA 01/01/2018 - 03/06/2018

Testing records for recall
https://www.fda.gov/Safety/Recalls/ucm482799.htm
COMPLAINT RECS RE KITTEN DEATHS 01/01/2018 - 03/01/2018
https://www.fda.gov/safety/recalls/ucm598161.htm
SEAN DUKE EMAILS RECS 06/01/2018 - 06/08/2018
CONTRACT RECS RE CLOUD COMPUTING
TESTING RECS RECALL
https://www.fda.gov/safety/recalls/ucm598255.htm
SAFE HAVEN BABY BOXES, WOODBURN, IN - INSP RECS 7/19/17
TESTING RECS RECALL, EATONTON, GA BLUE RIDGE BEEF
TESTING RECS RECALL STEVE'S REAL FOOD , SALT LAKE CITY, UT
TESTING RECS RECALL BIG DOG NATURAL, BRICK, NJ
8514834 8599691 8610603 ETC
A&Z PHARMACEUTICALS, HAUPPAGE, NY - 483, EIR, CORR 11/22/17
RECS RE SEARCH AND SEIZURE AT AMA LABORATORIES, NEW CITY, NY
01/01/2016 - 07/23/2018
ACTELION PHARMACEUTICALS US, SOUTH SAN FRANCISCO, CA - 483,
EIR, CORR 9/21/16
FDA FOIA LOG ABBOTT 02/01/2018 - 07/25/2018
QUESTIONS REGARDING USANA HEALTH SCIENCES, INC 01/01/2016 -
07/25/2018
QUESTIONS RE USANA HEALTH SCIENCES, INC 07/01/2013 - 07/25/2018

TCI LAB - INVESTIGATION, CMPLNTS, CORR, ETC
QUESTIONS RE USANA HEALTH SCIENCES, INC 05/01/2014 - 07/25/2018

FDA AGREEMENT WITH BUTANTAN INSTITUTE RE DENGUE VACCINE
08/13/2009 - 08/15/2009
FATALITY REVIEW TEAM CONCLUSION 18-036
ACELL, INC, COLUMBIA, MD - COMPLAINT RECS 11/01/2017 -
07/20/2018
ANDA 209996 SBA
ANDA 074254 SBA
NDA 017426 SBA
ANDA 071425 SBA
ANDA 208836 SBA
the 12 application numbers: 07-21629-18, 07-21634-18, 07-21635-
18 ETC
SCOTTS MIRACLE-GRO CO - WILD BIRD FOOD PRODUCTS1/1/08 TO
PRESENT
AVLON INDUSTRIES, MELROSE PARK, IL - 483, EIR, CORR 1/5/17
ACUDERM, FT LAUDERDALE, FL- 483, EIR, CORR 7/13/17
ACINO PRODUCTS, HAMILTON, NJ - 483, EIR, CORR 10/26/15
AFTON SCIENTIFIC, CHARLOTTESVILLE, VA - 483, EIR, CORR 9/15/17

AIRGAS USA, BILLERICA, MA - 483, EIR, CORR 5/9/17
APNEA SCIENCES CORPORATION, ALISO VIEJO, CA - 483, EIR, CORR
9/18/15
ARJ INFUSION SERVICES, LENEXA, KS - 483, EIR, CORR 5/25/17
ATRIUM MEDICAL CORPORATION, HUDSON, NH - 483, EIR, CORR 7/13/16

FCN 958
CDER CISST user manual, user acceptance test (UAT) report, and
validation report for the CISST
GMP LABORATORIES OF AMERICA INC - INVESTIGATION, CMPLNTS, CORR,
ETC
GILEAD SCIENCES POST APPROVAL STUDY RECSP
Supplemental approval information for NDA 209092 Supplement 1

ANDA 207989 ANDA 091161
ELI LILLY KINSALE LRD, IRELAND - 483 MARCH 2018
Veltassa, Patiromer FAERS
All discontinued NDC numbers along with the generic name and/or
trade name ETC
CLOZAPINE, CLOZARIL AERS, ETC
ANDA 080737
14271144 14336590 14339331 ETC
LIST OF APPROVED DRUGS SPECIFIED TO CANCER TYPE
CONGRESSIONAL CORR
COMM BETWEEN CDER AND HEALTH CANADA RE APOLLO HEALTH AND BEAUTY
CARE, CANADA
RECS CLINICAL TRIALS FOR ZHEIJIANG HUAHAI PHARMACEUTICAL LTD CO
Date Range: 01/01/2008 - 07/24/2018
CHONGQING IMPERIAL BIO CHEM CO LTD, CHINA ETC 483
8848814 9012316 8945184 ETC
FDA Import Refusal Data for Fishery and Seafood Products

AVIOQ, DURHAM, NC - 483, EIR, CORR 1/13/17
AMPHASTAR LABORATORIES, CHINO, CA - 483, EIR, CORR 10/21/16

ALZA CORPORATION, VACAVILLE, CA - 483, EIR, CORR 2/1/18
AIRGAS USA, PORTLAND, ME - 483, EIR CORR 12/13/17
K132662
KRAFT - MIO ENERGY WATER ENHANCER CONTAINING CAFFEINE 1/10 TO
1/13
Requesting a copy of the FDA import documentation with the

importer of record, Firm Legal Names as listed in the FDA
Importers list, listed as follows: Adams Extract & Spice LLC,
Adams Falvors Foods Ingredients, Adams Flv Foods & Ing, ADAMS
FLV FOODS
AEGLE NUTRITION, LLC, CARROLLTON, TX - EIR 11/28/2017 -
07/06/2018
DAILY LOG 7/9-13/18
DAILY LOG 7/9-13/18
WRIGLEY - ALERT GUM CONTAINING CAFFEINE RECS 1/1/13 TO 1/11/18

DAILY LOG 7/9-13/18
DAILY LOG 7/9-13/18
DAILY LOG 7/9-13/18
DAILY LOG 7/9-13/18
ANALYSIS OF CAFFEINE INTAKE BY THE US POPULATION - RECS 1/1/10
TO 1/11/18*
BK020051, BK070069, BK040068
ALLERMED LABORATORIES, SAN DIEGO, CA - 483, EIR, CORR 7/13/15

ALPHA MEDICAL INSTRUMENTS, MISSION VIEJO, CA - EIR, 483, CORR
6/4/15
ALK-ABELLO, PORT WASHINGTON, NY - EIR, 483, CORR 12/21/16
Response Letter from Natural Alchemist in response to the FDA
Warning Letter, Closeout Letter
DOSE OF NATURE RESPONSE TO WARNING LETTER, CLOSEOUT LETTER
GREEN GARDEN GOLD, LLC RESPONSE TO WARNING LETTER, CLOSEOUT
LETTER 02/05/2016 - 07/20/2018
THAT'S NATURAL! MARKETING & CONSULTING RESPONSE TO WARNING
LETTER, CLOSEOUT LETTER 11/01/2017 - 07/20/2018
DON LEE FARMS, LOS ANGELES, CA - EIR, 483, CORR 01/01/2010 -
12/22/2017
DRUG MASTER FILE (DMF) 11040
STANLEY BROTHERS SOCIAL ENTERPRISES LLC DBA CW BOTANICALS DBA
CW HEMP, RESPONSE TO WL, CLOSEOUT LETTER 11/01/2017 -
07/20/2018
COMMUNICATIONS WITH FRIENDS OF CANCER RESEARCH 01/21/2013 -
01/20/2018
"Programs on 'Mycotoxins in Foods'" (or similar) from the
"Compliance Program Guidance Manuals" (or similar) for the
years 1965 to 1974."
GREEN ROADS OF FLORIDA LLC RESPONSE TO WARNING LETTER, CLOSEOUT
LETTER 11/01/2017 - 07/20/2018
RECS RE CLAROS 1 PMA DEVICE FILING
EPI-NO ADVERSE EVENT, BAN OF DEVICE
GREEN TEA AERS
MECTA CORP, TUALATIN, OR - EIR, EXHIBITS, 483 ETC 07/01/2015 -
07/22/2018
LILLY FRANCE SAS, FRANCE - 483 4/4/17
TESTING RECS RECALL
STANDARD HOMEOPATHIC CO - INVESTIGATION, CMPLNTS, EVALUATION,
ETC LAST 10 YRS
Inspection information for all FDA inspections at tobacco
manufacturers conducted from June 2017 to June 2018
E-mails for Sean Duke sean.duke@fda.hhs.gov for the date of
June 22, 2018
TESTING RECS PRIMAL PET FOODS 07/01/2017 - 12/31/2017
Testing Recs Natural Selections Turkey With Organic Vegetables
Meals for Dogs, Lots #39937 and #40507 etc
I'm requesting the list of companies Sean Duke visited on
06.06.18 as part of any investigation
STRYKER GMBH, CH - 483 2/25/16
CHANGZHOU SUNLIGHT PHARMACEUTICALS LTD, CHINA - EIR 09/02/2017
- 07/02/2018
DR MOHAMED A EL-SHAHAWNY, LOS ANGELES, CA - EIR, 483 02/05/2015
- 02/16/2016
MAGNOLIA MEDICAL TECHNOLOGIES, SEATTLE, WA - EIR 02/22/2017 -
07/31/2017
2016-3653 2016-9935 2017-7660 ETC
K170722
SHIRE, LEXINGTON, MA - EIR 2016
BAXTER, CLARIS INJECTABLES LTD, INDIA - 483 07/27/2017 -
08/04/2017
THE FEMININA GROUP INC, SEATTLE, WA - 483 03/08/2018 -
03/14/2018
SUMMIT MEDICAL LLC, EAGAN, MN - 483 02/27/2018 - 03/09/2018

HERBAL INNOVATIONS LLC DBA HERBAL INGENUITY, WIKESBORO, NC -
EIR 04/02/2018 - 07/02/2018
NADA 100-616
CELLTRION, INCHEON, SOUTH KOREA - 483 06/25/2018 - 07/25/2018
Recall # Z-1124-2017
Laboratory Analysis Report for sample number 1046029
KORLYM AERS
APOMORPHINE HCL NASAL SPRAY FOR ERECTILE DYSFUNCTION - RECS,
CORR
RLD ACCESS INQUIRY FOR KORLYM 01/01/2015 - 03/08/2018
LUSOMEDICAMENTA TECNICA FARMACEUTICA, PORTUGAL - EIR
07/18/2016 - 07/22/2016
LETTERS FROM CONGRESS TO FDA RE SUBPART E OF FOOD SAFETY
MODERNIZATION ACT 11/08/2016 - 07/24/2018
FLUOROQUINOLONE SAFETY LABELING CHANGE RECS
K150522
P160007
P160048
K142086 K160805
PRIME NUTRITION, NORCROSS, GA DURACAPS, NORCROSS, GA -
COMPLAINTS, INVESTGATIONS, ETC Date Range: 01/01/2010 -
07/13/2018
ALKEM, DAMAN, INDIA - EIR 03/01/2018 - 07/24/2018
IMPORT ALERT 54-15
NDA 022161
NDA 017944
RECS COMMUNICATIONS, MEETINGS RE EFFORTS TO MODERNIZE
STANDARDS OF IDENTITY FOR YOGURT 04/01/2015 - 07/24/2018
Chemistry Review Memorandum dated 4/28/2017 from P. Turowski
to Dr. E. Petro of CFSAN regarding Food Contact Notification
(FCN) 001775
CXL-USA, LLC's Response to US Food and Drug Administration's

April 1, 2015 Warning Letter, Ref: 15-HFD-45-04-01
Supporting scientific information and the accompanying FDA

response for the structure/function claims provided for the
dietary ingredient(s) of Shilajit Fulvic Acid as stated in the
document FDA-2012-S-1144-1611
K001277 SUMMARY
K001277
RECS RE PHYSICAL ASSAULT AND ELAVIL
TENTATIVE APPROVAL LETTER ANDA 208532
NOOPEPT - NDA, IMPORT ALERTS, CORR, ETC
ny and all documents in which Tropical Smoothies Cafe was

declared as anFSVP importer and/or any and all other documents
that relate to the inclusion of Tropical Smoothies Caf on the
list of FSVP Food Importers
NDA 22287
Chemistry and Toxicology memorandum only of Food Contact
Notification (FCN) 1767
TSI No. 1781 (SAFETY-001781), i.e., Product: Proton Pump
Inhibitors
TSI No. 1579 (SAFETY-001579) pertaining to PDE5 inhibitors and
melanoma
Summary for Basis of Approval (SBA) for the Gablofen NDA 022462
Supplement 8
RECS FROM JUUL LABS TO FDA REQUESTE FOR INFORMATION RE
MARKETING PRACTICE 04/01/2018 - 07/25/2018
The summary basis of approval/ reviewer documents for the
approval of Lyrica (pregabalin) for fibromyalgia
NDA 200533 supplement 1 SBA
ANDA 208077 209506 SBA
JOSEPH WEIDER - RECS
NOVEN PHARMACEUTICALS, INC, MIAMI, FL - EIR JUNE 2015
CORR BETWEEN FDA AND JUUL 01/01/2018 - 07/25/2018
JINAD 012-532, submission ID# 0009, dated October 23, 2015
PRESTIGE AMERITECH K160100
P840029
PHILIP MORRIS USA INC - STN SE0014442, SE0014443, SE0014444,
SE0014445
INDIVIDUAL RECS
CONSUMPTION WARNING LBLG ON GATORADE
CASE RA-FDAORA-NE-170-18
HOSPIRA, MCPHERSON, KS HOVIONE, PORTUGAL PATHEON CINCINNATI,
OH ETC 483 01/01/2016 - 12/01/2017
NDA 06-703 APRVL
CRYOTRON 2 CRYOTHERAPY DVC K030281
ZYDUS ANDA 20-882
JOEL I BERNSTEIN & DR JOEL I BERNSTEIN MD INC - RECS
THALIDOMIDE RELEASED UNDER FOIA
INDIVIDUAL REC
2018-5587
INSULIN INFUSION PUMPS ADVERSE EVENTS BY AGE 01/01/2008 -
07/01/2018
TENTATIVE APPROVAL LETTER ANDA 208532
FLORIDA CORPORATIONS BUSINESS RECS 07/01/2013 - 07/25/2018
K011135
RECS RE ASSAY VALIDATION OF 4TH GENERATION QUANTIFERON-TB TEST

All sponsored research awards made to the Department of Surgery
at Duke University from 1938 to current
K173327
THE KROGER COMPANY, COLUMBUS, OH ETC - 483 08/11/2015 -
01/31/2018
MEDPACE INC, CINCINNATI, OH ETC 483 06/05/2017 - 04/20/2018
KEDPLASMA LLC, PENSACOLA, FL EIR 08/28/2015 - 09/05/2015
MYLAN PHARMACEUTICALS, MORGANTOWN, WV - MEMOS, EMAILS ETC RE
INSPECTION
K152948
CRYOLIFE, KENNESAW, GA - EIR 01/01/2015 - 12/31/2015
RECS RE INTERACTIONS BETWEEN MEAD JOHNSON AND FDA RE ENFAMIL
NEUROPRO INFANT FORMULA
NDA 006799
K153229
K171610
K171566
All communications, including emails or letters, between FDA

and any other government entity, issued between October 3, 2017
and present, that discuss GRAS notices 10/03/2017 - 07/26/2018
All documents relating to GRAS Notices 540 (Soybean

leghemoglobin from Pichia pastoris) and 737 (Soy leghemoglobin)
CELLTRION INCHEON, S KOREA - 483 JULY 2018
Opdivo Supplemental approval information BLA 125554/S41
Copies of Form 483's issued by the Atlanta District Office from
June 1-30, 2018
483s issued by the CDER International Operations Group in June
2018
DMF 1145
LUPIN LIMITED, INDIA - RESPONSE TO 483 04/01/2017 - 12/22/2017

CDRH BENCHMARKING STUDY 01/01/2010 - 12/31/2010
EDWARDS LIFESCIENCES LLC, IRVINE, CA DRAPER, UT - INSPECTION
REPORTS, WARNING LETTERS 01/01/2015 - 01/01/2018
K171277
2018-5075
All documents previously released under FOIA regarding the

application submitted to the FDA on June 27th 2011 seeking
approval for Investigational Device Exemption for the Cadisc-L
spinal device by Ranier Technology
STARFLEX SEPTAL CLOSURE DEVICE CLINICAL TRIAL RECS
RECS RE FILSHIE CLIPS
EFFECTIVE APPROVAL LETTER ANDA 203649
BREAST IMPLANT MAUDE REPORTS
FAERS 7761823, 3833104, 3040226, ETC
FOIA DAILY LOG 12/16/2017 - 01/18/2018
CPT1701184 CPT1701265
MAUDE REPORT 9617229-2015-00232
2018-2314 2018-4148
FOIA LOG JULY 2018
PHILIP MORRIS USA INC - SUBSTANTIAL EQUIVALENCE RPTS STN
SE0000602, SE0000603
JUUL LABS INC - FDA LTR 4/24/18 (STN RD0000476)
BIONPHARMA INC - CLOBAZAM ANDA 208-825 TENTATIVE APRVL LTR
CYMBALTA - AERS 2004 TO PRESENT
GENVOYA REYATAZ - CLNCL TRIAL RECS
BREAST IMPLANTS - MDRS
SSM HEALTH CARE CORPORATION, FENTON, MO - EIR 10/23/2017 -
11/16/2017
MINERALILFE NEUTRACEUTICALS LLC, COLORADO SPRINGS, CO - DOCS

K173595
TITAN KOGYO LTD, JAPAN - 483 07/01/2017 - 07/31/2017
LEAD CHEMICAL CO, JAPAN - 483 07/01/2017 - 07/31/2017
LIST OF INSPECTIONS JULY 2018
LOG OF CLOSED FOIA REQUESTS JULY 2018
K151459
IWAKI SEIYAKU, JAPAN - 483 09/01/2017 - 09/30/2017
NOVEN PHARMACEUTICAL, MIAMI, FL - EIR 06/22/2015 - 12/31/2015

FOIA LOG EXCEL 07/11/2018 - 07/30/2018
CADILA HEALTH API UNIT, INDIA - 483 01/01/2018 - 01/19/2018
CHARLES RIVER LABORATORIES, RENO, NV BIOAGILYTIX, DURHAM, NJ
- EIR 01/13/2017 - 08/17/2018
CELLTRION INCHEON, S KOREA - INSPECTION RECS 04/01/2018 -
07/31/2018
MEDICAL DEVICE RECALL DATA 01/01/1980 - 09/30/2002
NDA 21248 S-015
DAITO KASEI KOGYO CO LTD, JAPAN - 483 07/01/2017 - 07/31/2017
STELLA CHEMIFA CORPORATION, JAPAN - 483 07/01/2017 - 07/31/2017

UNICHEM LABS, INDIA - 483 07/01/2018 - 07/30/2018
Supplemental NDA for Trintellix (vortioxetine), including
supplement 6 approved May 2, 2018
8 ANDA APPROVAL LETTERS

FAERS 15147330 15147342
FCN 1169
Docket FDA-2015-P-0569
K100635
2017-1609 2017-3436 2017-3743 ETC
IWAKI SEIYAKU CO LTD, JAPAN - 483 09/01/2017 - 09/30/2017
NEW DAY - IBUPROFEN MFRS NAME, DISTRIBUTORS ADDRESS
IOVATE, HYDROXYCUT, CREATINE, ETC - CAERS
RECS RE EFFECTS OF INTRAVENOUS IMMUNOGLOBULIN ADMINISTRATION ON
PLATELET COUNTS OVER TIME IN IDIOPATHIC THROMBOCYTOPENIC
PURPURA
RECS RE IMPACT OF CDC GUIDLINE FOR PRESCRIBING OPIOIDS FOR
CHRONIC PAIN
RFR RECS ASSOCIATED MILK PRODUCERS

REPORTS, STUDIES, ANALYSIS BY FDA SOCIAL MEDIA LISTENING
PLATFORM RE ARTICLES, READER COMMENTS, ETC ABOUT CONTROLLED
SUBSTANCES, PRESCRIPTION DRUGS, KRATOM
VETTER PHARMA - 483 01/10/2015 - 01/21/2017
Drug manufacturing inspections records
OCI CASE FILE
CHUN CHLORELLA USA REPORT RE REJUV-A-WAFERS
KERRY INC, GRIDLEY, IL - 483, EIR ETC 01/01/2016 - 07/31/2018

Most recent "OSC" review or post marketing safety review that
led to the March 2, 2018 Drug Safety Communication regarding
the withdrawal of Zinbryta (daclizumab)
K171810
NDA 008845
ZHEJIANG HUAHAI PHARMACEUTICAL, CHINA - 483 5/19/17
MYLAN PHARMACEUTICALS, MORGANTOWN, WV - RESPONSE TO 483
04/12/2018 - 07/31/2018
ADMA BIOLOGICS, BOCA RATON, FL - EIR MARCH 2016
GERMAN HEALTH AUTHORITY CAPABILITY ASSESSMENT 01/01/2017 -
01/18/2018
AJINOMOTO ALTHEA, INC, SAN DIEGO, CA - EIR, 483 04/01/2017 -
04/30/2017
K173084
Orphan Drug Designation letter for tiopronin to Dr. Pak
GRN 540 GRN 737
MATRIX SURGICAL , ATLANTA, GA - EIR 07/18/2018 - 07/31/2018
RECS RE INSPECTIONS SKY RIDGE MEDICAL CENTER, LONE TREE, CO
01/01/2010 - 01/01/2016
DIFFERIN GEL - ISRS 14702048, 13790775M 13790722, ETC
K151604 K980025 K980027
RECS SUBMITED BY JUUL LABS 05/31/2018 - 07/31/2018
CELLTRION INCHEON, S KOREA - 483 07/01/2018 - 07/16/2018
NDA 21077 S-056 S-057
All meeting minutes, meeting agendas, or decision logs
regarding the June 2018 Nicotine Steering Committee monthly
meeting
USANA HEALTH SCIENCES, CHINA - INSPECTION RECS 01/01/2015 -
07/31/2018
OIL OF MUSTARD FDABF-GRAF-131
STRIDES SHASUN LIMITED, BANGALORE, INDIA ETC - EIR 05/01/2017
- 08/01/2018
K172460
NDA 208418
All applications for any use, approved and unapproved,
including clinical studies for Dimethyl Sulfoxide
P180002 P080032
APS BIOGROUP INC - WARNING LTR 7/6/17
METHOD PHARMACEUTICAL, LLC, FORT WORTH, TX - EIR, 483 RESPONSE
01/01/2015 - 08/03/2018
K024322
ANDA 090887
SE0014067 SE0014118
FREDERICK ROBINSON MD, NINETY-SIX, SC - 483 01/01/2004 -
08/02/2018
YUKI GOSEI KOGYO CO LTD, JAPAN - 483 11/01/2017 - 11/30/2017

NDA 19430
October 1995 ODAC meeting transcript
K172593
DEN170009
SUMIKA CHEMICAL ANALYSIS SERVICE, LTD, JAPAN - 483 06/01/2018
- 06/30/2018
AKORN PHARMCEUTICALS INC, DECATUR - 483, SUBPEONAS 01/01/2018 -
08/01/2018
K162219
Food Contact Notification 53 by BASF Corporation
All FAPs filed with FDA RE Oxidized bis (hydrogenated tallow

alkyl) amines, for the uses, as listed in 21 CFR 177.2010
K110010
Spreadsheet identifying the name and contact information
related to each Drug Master File (DMF) Original Submission from
January 1, 1989, to December 31, 1989
K163355, K053363
SYNED LABS LIMITED, INDIA INDOCO REMEDIES, INDIA INOGENT

LABORATORIES PRIVATE LTD, INDIA 483 05/01/2018 - 05/31/2018
ANDA 200925
INVACARE CORP - ELECTRIC WHEELCHAIR CMPLNTS, WARNINGS,
MANUFACTURING, ETC 2008 TO PRESENT
INDIVIDUAL RECS - LORAZEPAM
2015-1496, 2017-4106, 2017-2692
NDA 006773
SEKISUI MEDICAL MTD, JAPAN - NAI CLASSIFICATION LETTER
11/07/2017 - 11/07/2017
RES-Q - IND
INDIVIDUAL RECS
CONCEPTUS INC, BAYER CORP - ESSURE MFR SAFETY DATA SHEETS
HPHC data for smokeless tobacco products
FOVISTA CLINICAL TRIAL RECS
ADVERSE EVENT REPORTS RE DEVICES MARKETED FOR USE IN VAGINAL

REJUVENATION, PUBLISHED LITERATURE 03/01/2016 - 08/01/2018
RECS RE DATA INTEGRITY ISSUES
RECS RE DATA INTEGRITY ISSUES
PALL INTERNATIONAL, SWITZERLAND - EIR, FMD 145 LETTER
01/30/2017 - 02/05/2017
LIST OF 483S FOR INSPECTIONS IN CHINA, INDIA 01/02/2017 -
01/01/2018
BIOCOAT INC, HORSHAM, PA - EIR 11/17/2017 - 11/17/2017
K173675
PROTEIN RESEARCH, LIVERMORE, CA - EIR 01/02/2017 - 07/31/2018

ANDA 207550
THIOLA NDA 019569 ORPHAN DRUG DESIGNATION LETTER
CORR, REPORTS ETC RE TRF, SIMILASAN SENT, CREATED, MAINTAINED
BY CDER 01/01/2014 - 08/01/2018
AKORN PHARMACEUTICALS INC, SOMERSET, NJ AMITYVILLE, NY,
CRANBURY, NJ ETC - 483 ETC 01/01/2018 - 08/01/2018
AKORN, HETTLINGEN, SWITZERLAND - 483 01/01/2018 - 08/01/2018

FERRING PHARMACEUTICALS INC, PARSIPPANY, NJ - 483 05/01/2008 -
06/15/2007
FERRING PHARMACEUTICALS INC, PARSIPPANY, NJ - 483 10/01/2008 -
11/01/2008
GIVE AND GO PREPARED FOODS CORP - RECALL RECS (CERTIFIED)
01/01/2017 - 09/30/2017
Information regarding the July 2018 Nicotine Steering Committee
monthly meeting
LIST OF INSPECTIONS, ETC 08/01/2017 - 08/01/2018
RECS RE COMPLAINT
DEN160032 REVIEWER RECOMMENDATIONS, NOTES
AMERICAN RED CROSS, ALABAMA AND CENTRAL GULF COAST REGION,
MOBILE, AL - EIR 08/21/2017 - 08/24/2017
HHS-FDA-DE-18-10241151
RECS RE SOCIAL MEDIA LISTENING PLATFORM 01/01/2017 -
08/03/2018
LIST OF WARNING LETTERS 10/01/2011 - 07/31/2018
UNICHEM LABORATORIES LTD, INDIA - 483 07/26/2018 - 07/27/2018

BACKGROUND CHECK
JAMIESON - FORM 3500, 3500A, 3500B 10/17 TO 9/31/17
Summary Basis of Approval (Approval Package) for Latanoprost
Ophthalmic Solution/Drops, 0.005%, approved under ANDA 091449
on March 22, 2011
on March 22, 2011
on March 22, 2011
on February 11, 2013
on April 22, 2016
ANDA 207989 SUMMARY OF BIOEQUIVALENCE STUDIES
K163686 K163686/S001 REVIEWS
BRAD, KAHL, UNIVERSITY OF WISCONSIN HOSPITAL AND CLINICS,
MADISON, WI - 483 05/04/2015
PHENOBARBITAL PHENOBARBITAL SODIUM SBA
All applications, approved and unapproved, for any use for
animals of Dimethyl Sulfoxide
CORR FROM DR. SCOTT GOTTLIEB IN 2017
PENTASA - ANDA COVER LTRS 1/1/15 TO 8/1/18
ZEOLITE A FCN 47
PENTASA - PAGE 1 OF THE ANDA FILING CHECKLIST (MAPP5200.14)
APS BIOGROUP INC - WARNING LTR 7/6/17
2015-8242, 2015-2355, 2015-2235, 2014-4039
K091272, K021446, K021442
PREVIOUSLY RELEASED 483, RESPONSE, EIR JULY 2018
PREVIOUSLY RELEASED 483, EIR, RESPONSE 06/30/2018 - 08/01/2018

ENFORCEMENT REPORTS 08/01/2011 - 08/01/2018
OPTOVUE, INC, FREMONT, CA - EIR 02/01/2017 - 08/01/2018
DEVON SHOOP, KATHRYN KRENTZ, MARGARET FOSTER ETC - CV
01/01/2010 - 08/02/2018
K180151
ETEX CORP - BETA-BSM K090242, ETEX CORP - GAMMA-BSM K090242,
ETEX CORP - ALPHA-BSM K091729 ETC
K173200
K180008
MEMO RE PRODUCT QUANTITY CHANGES SE0013974-SE0013976
NDA 210566
DAEWOONG PHARMACEUTICAL, SOUTH KOREA - FMD 145 LETTER
01/01/2017 - 08/02/2018
K102597
ENTRIES HARRIS TEETER FSVP IMPORTER
COMMUNICATIONS BETWEEN FDA AND REPUBLIC TECHNOLOGIES, REPUBLIC
TOBACCO, DRL ENTERPRISES INC ETC RE BBK TOBACCO & FOODS
CIGARETTE ROLLING PAPERS 01/01/2008 - 07/01/2018
NOVABAY PHARMACEUTICALS, EMERYVILLE, CA SONOMA
PHARMACEUTICALS, PETALUMA, CA ETC - 483, EIR, CORR 01/01/2016 -
08/03/2018
Form 483 or FMD 145 for Celltrion's Incheon facility
BILLINGS CLINIC, LIVINGSTON, MO - 483, EIR, WARNING LTR 1/2000
TO PRESENT
K061771
BPA LEVELS
DEN160020 DEN160044 K081140 K171056 K173327
Amprolium Type B and C feed methods
K030861
GRN 716
K150608 K161040
NUTRIPACK LLC, MARKHAM, IL - EIR OCT 2017
510K summary for K090932
510K Summary for K803057 FOGARTY BALLON ANGIOPLASTY CATHETERS

CASE 16CECG01874
UNICHEM LABORATORIES LTD, INDIA - 483 08/03/2018 - 08/07/2018

510K Summary for K901625 FOGARTY ARTERIAL EMBOLECTOMY II
CATHETER
SMITH & NEPHEW, INC, MEMPHIS, TN - EIR 07/01/2017 - 08/03/2018

List of all tobacco inspections 06/01/2017 - 06/30/2018
Reviewer notes for Swisher International Inc. products: Kayak
Fine Cut Natural (SE0001910) and Kayak Long Cut Wintergreen
(SE0001916)
DRUG APPROVAL PACKAGES
BLA 125156 S117 & S112
483, EIR RELEASED JULY 2018 07/01/2018 - 07/31/2018
2017-6000
CELLTRION, KOREA - 483 05/01/2018 - 08/03/2018
CORR BETWEEN FDA AND TTB RE FERMENTATION PROCESS FOR THE
MANUFACTURE OF VANILLIN AS A NATURAL PROCESS RESULTRING IN A
NATURAL PRODUCT
PURE TEK CORP - DOCS
MINUTES OF MEETING BETWEEN SCOTT GOTTLIEB AND INDUSTRY RE PDUFA
VI 07/18/2018
SE0000103 SE0000083 ETC REVIEWER NOTES
Reviewer notes for R. J. Reynolds Tobacco Company products,
Eclipse (SE0006177) and Eclipse Menthol (SE0006178)
K151127
OCREVUS FAERS
HEMLIBRA FAERS
OCALIVA FAERS
NUPLAZID FAERS
Grant HHSN271201000003C, U54SA031659
CVM APPROVED ANALYTICAL TEST METHODS FOR DETERMINATION OF
LAIDLOMYCIN IN: 1. TYPE B FEED PRODUCTS AND 2. TYPE
C FEEDS
NDA 21-077
MEDICATED FEED MILLS - 483, EIR 1/2013 TO PRESENT
K090993 - RECALL 65072
PORTOLA PHARMACEUTICALS INC - ANDREXXA (COAGULATION FACTORY XA)
ORPHAN DRUG DESIGNATION
RISPERIDONE, PALIPERIDONE, HALOPERIDOL, ETC. - AER
BLENOXANE - CERTIFIED COPIES
JUUL LABS - DOCS 6/19/2018
VALSARTAN - RECALL ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD CORR
WITH FDA
FORM FDA 356 FOR PENTASA 1/15 TO PRESENT
INDIVIDUAL RECS
LIST OF INSPECTIONS DRUGS, DEVICES ETC 06/01/2018 - 07/31/2018

VIA CHRISTI HOME MEDICAL & SALINA REGIONAL HOME MEDICAL
SERVICES, KS - 483, EIR, WARNING LTR 1/98 TO PRESENT
ZHEJIANG HUAHAI PHARMACEUTICAL CO, LTD, CHINA INSPECTION RECS
11/18/2016 - 05/19/2017
DIRECT MESSAGES FROM FDA TWITTER ACCOUNT, COMMISSIONER TWITTER
ACCOUNT 11/01/2016 - 07/31/2018
2018-5689
ELENA VALOR, MIAMI, FL ETC 483 04/26/2016 - 07/20/2017
RECS RE CELLTRION WARNING LETTER 01/26/2018 - 08/31/2018
TIDEATER PHYSICIANS FOR WOMEN DBA FRANKLIN MORGAN JR, MD,
NORFOLK, VA ETC 483 03/22/2017 - 04/12/2018
CHARTER MEDICAL LIMITED, WINSTON SALEM, NC ETC 483 02/10/2015 -
12/11/2017
RECS RE STUDIES, ADVERSE EVENT REPORTS VAGINAL REJUVINATION ETC
01/01/2010 - 08/04/2018
RICHARD RP WARNER, MD, NY, NY ETC 483 12/03/2012 - 07/27/2017
RADIUS HEALTH, INC, WALTHAM, MA ETC 483 01/05/2015 - 06/28/2017

FREEPORT HOME MEDICAL EQUIPMENT, IL - EIR, 483, WARNING LTR
1/98 TO PRESENT
NICO DE VRIES, AMSTERDAM GERRIT J BOUMA, AMSTERDAM - 483
01/01/2008 - 08/01/2018
SARANAC BRAND FOODS, INC, SARANAC, MI ETC 483
UCSF HUMAN ISLET & CELLULAR TRANSPLANTATION FACILITY, SAN
FRANCISCO, CA ETC 483 03/16/2010 - 11/21/2017
Change Notice Letter June 2013 from Pfizer to FDA for the drug
Depo-Medrol
NDA 021153, NDA 021957 NDA 022101 ETC MEETING MINUTES ADVISORY
COMMITTEE
RECS RE APPLICATION FOR APPROVAL OF IDE FOR CADISC-L SPINAL
DEVICE
LUTHERAN MEDICAL CENTER, WHEAT RIDGE, CO - INSPECTION RECS
01/01/1983 - 08/06/2018
EXPAREL MEDWATCH REPORTS
POLARITYTE, SALT LAKE CITY, UT - INSPECTION RECS 05/01/2018 -
08/06/2018
ADVERSE EVENT REPORTS, COMPLAINTS FOR COMPRESSION, MEDICAL
SUPPORT STOCKINGS 05/01/2007 - 08/06/2018
TAMBRA INVESTMENTS INC, MI - EIR, 483, WARNING LTRS 1/98 TO
PRESENT
PINNACLE FOODS GROUP INC, BOULDER, CO ETC 483 12/16/2015 -
12/02/2016
J THADDEUS BECK, MD, FAYETTEVILLE, AR 483 ETC 04/29/2014 -
11/16/2017
JULIE N GRAFF, MD, PORTLAND, OR ETC 483 03/31/2014 - 11/14/2017

JUBILANT HOLLISTERSTIER GENERAL PARTNERSHIP, KIRKLAND, CANADA
483 ETC 11/28/2016 - 09/22/2017
INVESTIGATION RECS
2016-8674 2017-1230 2017-4535 ETC
RECS RE VOXELOTOR
Complete action packages for SNDAs
Complete action packages for NDAs

ABBOTT MITRACLIP MAUDE DETAILED NARRATIVE
OLYMPIC OXYGEN, WA - EIR, 483, WARNING LTR 1/98 TO PRESENT
NADA 100-237
MEDTRONIC, JUNCOS, PR, ZIMMER MANUFACTURING, PR ETC - 483,
RESPONSES ETC
RHOPRESSA FAERS
GUY & O'NEILL, FREDONIA, WI - 483, EIR 01/01/2008 - 08/06/2018

CVM SUMMARY REPORT ANTIMICROBIALS SOLD OR DISTRIBUTED FOR USE
IN FOOD PRODUCING ANIMALS 01/01/2016 - 12/31/2016
Adverse reactions to Simparica, oral flea and tick preventative
for dogs
PENTASA - FORM 3794 1/15 TO PRESENT
BTG INTL INC - EKOS ULTRASOUND EVD DVC K0172035
K & S KALI GMBH, PHILIPPSTHAL - EIR, 483 REDACTED
LIVESTOCK PRODUCERS IN VIRGINIA
GORE DUAL MESH BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL
K0634435, AER, CORR 1/06 TO PRESENT
BARR LABORATORIES, FOREST, VA - EIR, 483, CORR 2/28/18
BIOLOGICS CLINICAL TRIALS SUBMITTED BY MARK RUBIN LASKY EYE
CENTER 02/01/2011 - 06/12/2017
BIOANALYTICAL LABORATORY, EPCU BLOEMFONTEIN RSA, SOUTH AFRICA
06/30/2016 - 02/28/2018
MERCK & CO, INC, UNION, NJ ETC 483 12/09/1999 - 12/21/2016
ZOGG, DONALD L, MD, SAINT PAUL, MN ETC 483 06/08/2015 -
01/17/2018
SMILE DIRECT CLUB CORR RE USE OF MEDICAL DEVICE INCONSISTENT
WITH 510K
JOSEPH DOUGHERTY, JULIANA FALLA, KIMBERLY LICHTER ETC CV
WESTERN CHEMICAL INC OVAPRIM REQUEST FOR ADDITION TO INDEX OF
LEGALLY MARKETED UNAPPROVED NAD FOR MINOR SPECIES 01/01/2007 -
04/01/2009
DANIEL CLAASSEN, MD, NASHVILLE, TN ETC 483 05/19/2014 -
09/17/2015
CTP Grant U54DA031659
DUAL MESH EMERGE EMERGE PLUS BIOMATERIAL K022782, CORR, AER
1/02 TO PRESENT
ASANUMA CORPORATION, JAPAN 483 06/01/2018 - 06/30/2018
The number of cosmetic formulations registered under the FDA's
Voluntary Registration of cosmetics/Ingredients
AMBIOPHARM, NORTH AUGUSTA, SC - 483 07/01/2017 - 07/10/2017
Individual Case Safety Report Request Novopulman 200 Novolizer
FAERS 14583382
K123486
SHIONO FINESSE LTD, JAPAN - 483 06/01/2018 - 06/30/2018
K170551 DEN150037
CTP Grant U54031659
K063349
K102925
GORE TEX DUAL MESH PLUS BIOMATERIAL K946106, AER, CORR 1/94 TO
PRESENT
CELLTRION, KOREA EIR 07/01/2018 - 08/07/2018
15089211 15072711 15058363 ETC
NIDA/FDA Grant U54DA03169
Pack insert for REGITINE (PHENTOLAMINE MESYLATE) 5mg/Vial held
by NOVARTIS PHARMACEUTICALS CORP
DEN150037
NDA 018513
NCTR RECS RE CRADA ETC

ROSE ACRE FARMS - SALMONELLA OUTBREAK 2018 INSP RECS, PATHOGEN
TESTING, ETC
CORR BETWEEN FDA AND POLARITYTE AND SKINTE
All call for training requests by FDA University supervisors
and managers (including the Chief Learning Officer) to all
staff FDA University staff, including due dates for training
requests to be submitted for consideration 11/13/2015 -
08/07/2018
K171120
Guidance and instructions from FDA University managers and

supervisors ( including the Chief Learning Officer) to FDA
University staff on Individual Development Plans including
what the supervisors/mangers role is in the Individual
development plan pr
WESTERN CHEMICAL, INC REQUEST FOR ADDITION TO INDEX OF LEGALLY
MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR MINOR SPECIES OF THE
DRUG AQUACALM 01/01/2007 - 07/01/2009
RECS RE BIOQUAL INC, ROCKVILLE, MD RESEARCH OR BREEDING OF
CHIMPANZEES 01/01/2004 - 08/07/2018
OCULAR THERAPEUTIX, BEDFORD, MA - EIR 01/01/2016 - 08/07/2018

INDUSTRIAS QUIMICAS FALCON DE MEXICO RECS RE 2011 IMPORT BAN
2009-2013
RECS RE STUDY REDUCED NICOTINE CIGARETTE
Training budget for each division within The FDA Office of
Human Resources, including FDAU University 01/01/2015 -
08/07/2018
RECS RE OO DEPUTY CHIEF OPERATING OFFICER PRESENTATION ON FDA
MENTORING PROGRAM AT FEW, BIG CONFERENCES 2017
Names of all FDA employees that attended the FEW and/or BIG
conferences in 2017 and/or 2018
RECS RE NEUROCORE BRAIN PERFORMANCE COMPLAINTS, ETC 08/01/1995
- 08/07/2018
RECS E OPANA ER
ATL, MENOMONEE, WI - EIR, 483, RECALLS 04/01/2015 - 01/19/2018

MOHAMED EL-SHAHAWY, LOS ANGELES, CA ETC 483 01/06/2014 -
06/01/2017
TRAINING REQUESTS SUBMITTED TO FDAU SUPERVISORS, REQUESTS
GRANTED 01/01/2016 - 08/07/2018
WOCKHARDT CLINICAL PHARMACOKNETICS AND BIOPHARMACEUTICS, INDIA
- EIR 05/30/2016 - 06/10/2016
PFM MEDICAL MEPRO GMBH, GERMANY - EIR 01/22/2015 - 08/07/2018

All available documents relating to the FDA approval of Merck &
Co.sKEYNOTE-189 (NCT02568680)
Organizational chart including staffing changes within FDA

University, including names, grade levels, and assigned major
work functions or projects of FDAU University employees and
including staffing changes for each FDA University team during
the tim
RECS RE UNITED SAFETY AGENTS FSVP 07/23/2018 - 08/15/2018
K153049
INDIVIDUAL RECS
FDA Minutes for the October 7, 2015 PIND meeting between M.

Alphabet 2, LLC and the CDER Division of Dermatology and Dental
Products on the subject of picropodophyllin gel for actinic
keratosis
BOSTON SCIENTIFIC, SAN JOSE, CA - EIR 01/01/2017 - 03/01/2017
Emails sent or received by FDA employees Lisa Capron and Lawton

Lum, that mention kratom and/or salmonella, both to and from
one to the other and to/from anyone else, from January 1st 2018
through August 3rd, 2018
Information regarding an intramural grant
WORLD HEALTH ORGANIZATION GRANT APPLICATION 1U18FD006317-01
CLOSED FOIA REQUESTS EXCEL 06/07/2018 - 08/08/2018
2018-1387
MARQUEZ ROBOTIC ORTHOPEDIC INSTITUTE, EDINBURG, TX - RESPONSE
TO WARNING LETTER 03/01/2004 - 06/01/2004
Pre-IND meeting minutes PTS#PS001974 for CTL019 ETC
Information regarding a joint grant from FDA & NIH
RPTS DPATR-FY17-186, DPATR-FY17-208, FY18-037-DPA-T, ETC - LAB
ANALYSIS, TESTING,
GUARDIAN PHARMACY SERVICES - FDA SAMPLES 940181 LAB ANALYSIS,
COLLECTION RPTS
K020537
Summary basis for approval for triptorelin as a long acting
injection. 3.75 mg 11.25 mg and 22.5 mg injections
K170551
MEETING MINUTES SEPTEMBER 2016 REMOVAL OF BLACK BOX WARNING
FROM CHANTIX 2016 ETC
TISSUE REFERENCE GROUP DECISION THAT HUMAN FECAL MATTER DOE
SNOT MEET STATUTORY DEFINITION OF A HUMAN TISSUE FOR REGULATORY
PURPOSES 01/01/2011 - 12/31/2013
K133237
K143615
Spreadsheet of 483s issued in July 2018
FAERS CASE ID 14767290
NDA 009766 NDA 009986 PRESCRIBING RECS
BSN MEDICAL INC, CHARLOTTE, NC - EIR 11/01/2017 - 11/08/2017

K760699
GREEN CROSS CORPORATION - EIR 05/01/2016 - 08/08/2018
MONTERIS MEDICAL Q180739 Q180739/S001
CATALENT PHARMA SOLUTIONS, MORRISVILLE, NC - EIR 05/15/2017 -
05/19/2017
FOIA REQUESTS RITUXAN 11/26/1997 - 08/14/1999
ORPHAN DRUG ACT SUBMISSION DATA, TAX CREDIT PAYMENTS
K023723
FOI DAILY LOG 7/30/18-8/3/18
FOI DAILY LOG 7/30/18-8/3/18
FOI DAILY LOG 7/30/18-8/3/18
FOI DAILY LOG 7/30/18-8/3/18
FOI DAILY LOG 7/30/18-8/3/18
UNITED CATERING, SAN FRANCISCO, CA - HEALTH AND FOOD SAFETY
INSP RPTS 1/1/17 TO PRESENT
NDA 204623
K180111
BRYAN CORPORATION, WOBURN, MA - INSPECTION RPT 03/01/2016 -
08/31/2016
Orphan drug designation information for Bendeka
All records pertaining to the FDA Unified Registration and

Listing Systems (FURLS) Winning bid proposal and solicitation
FOOD FACILITY DATA 01/01/2001 - 08/01/2018
NDA 202922
BAYSCIENCE FORMULATORS, DUDLEY, MA - EIR, CORR, 483 11/23/15

31 Insulin ISR's
2018-5001
BAXALTA US, MILFORD, MA - EIR, CORR, 483 2/23/16
K153239
PERISHABLE JAMAICA LIMITED, JAMAICA - EIR 09/25/2017 -
04/30/2018
ADVERSE E VENT REPORT
Submission and correspondence that was the basis of the AAFCO
Definition for Tall Oil in the early 1990s
Environmental Assessment submitted by RAI Services Company for
the Eclipse Product (SE0014246) ETC
RECS RE BLACK BOX WARNING REMOVED FOR HUMAN DRUGS 01/01/2010 -
08/08/2018
PHARMATEK LABORATORIES, INC, SAN DIEGO, CA - EIR 02/06/2006 -
02/23/2006 (CERTIFIED)
2015-6861
Brentley Collins, Brian Campbell, Capri Woolridge ETC CV
K151620
MEDPLAST MEDICAL INC, GRAND RAPIDS, MI - EIR 06/27/2016 -
06/29/2016
Information regarding an intramural grant
NUPLAZID AERS
EMAIL FROM MARGARET HAMBURG RE LEVAQUIN 03/05/2009 - 01/01/2012

K153049
ORAJEL SAFETY REVIEWS, ANALYSIS RE 5/23/18 SAFETY
COMMUNICATIONS
RAIN THERAPEUTICS INC - TH-4000 IND 11290 RECS
APOTEX ANDA 211-067 - APRVIL LTR, MEMOS
AIRGAS USA LLC, AIRSOURCE INDUSTRIES, NITROUS OXIDE CORP -
NITROUS OXIDE WARNING LTRS INDIVIDUAL RECS
MARY'S HARVEST FRESH FOODS, PORTLAND, OR - SALMONELLA
INVESTIGATION RECS, RPTS, EMAILS, ETC
BAILEY FARM LLC, MARSHALL, WI - EIRS, 483S, TEST RESULTS, ETC
1/1/13 TO 12/31/17
EVANGER'S DOG & CAT FOOD COMPANY INC, WHEELING, IL - EIRS,
483S, CORR, ETC 1/1/13 TO 12/31/17
QUESTIONS ABOUT MARPLAN
LETTER FROM HERBERT L LEY JR TO BARBARA SEAMAN 01/01/1969 -
12/31/1969
DEN140017
FOREIGN DRUG INSPECTIONS, STAFF
RECOMBIVAX HB - CLNCL TRIAL RPTS
EPIEP INC - EPIACCESS SYS K142245
LASKY LASER CENTER, LASKY CLINICAL SURGERY CENTER, BEVERLY
HILLS, CA - INPS 2003 TO 2018
RECS RE JUDGE ROTENBERG CENTER 01/20/2016 - 08/01/2018
COMMUNICATIONS BETWEEN FDA POLITICAL APPOINTEES AND MINDY
BRASHEARS
HHS, FDA RESPONSE TO WHO RE CANNABIS INQUIRY 04/09/2018 -
06/18/2018
WORK COMPLETED BY FDA ON FDAA SECTION 1002 FOR INGREDIENT
STANDARDS AND DEFINITIONS ETC 09/27/2007 - 08/08/2018
Solication # FDA-NOI-1201156 requirements
Reports and Corr between FDA and MiMedx
K172130
522 orders from 01/01/2012 - 08/08/2018
Orphan Drug Designation Application for adalimumab (approved
trade name Humira)
EIR and 483's for General Mills Irapuato, Mexico 06/30/2017 -
08/31/2017 first party request
General Mills EIR and 483's Wellston, OH 06/11/2017 -
11/17/2017 first party request
CV's of the following FDA Inspectors: Emmanuel Dimaano, Liliya

Bubiy, Paul Licata, Christopher Wilcox, Jake Lane, Lewis Antwi,
Matthew Morrison, Michael Cimaglio, Tania Vizcaino, and Cody
Alley.
FAERS Case Records Hemlibra
LONHALA MAGNAIR KIT SBOA and reviews

OptiNose, Yardley, PA EIR May 15-May 26 2017 first party
Beckman Coulter, San Fran, CA EIR, 483 and Corr Oct 2017
#CC 151454 results
SUITABILITY PETITIONS PREDNISONE SODIUM PHOSPHATE 01/01/2005 -
12/22/2017
MAVYRET FAERS
PEN-VEE K registration data label clinical etc.
FOIA Log 07/30/2018 - 08/13/2018
483 Promiel SRL 02/21/2018 Argentina HIZUKA SUISAN KAKOU CO.,

LTD. 02/16/2018 Japan PIRAQUE 08/25/2017 Brazil AGV Products
Corporation 12/07/2017 Taiwan Productos Ultra, S.A. de C.V.
03/08/2018 Mexico. Ve Wong Corporation Fong Tien 12/14/2017
Taiwan
21CFR822.7 requests Date Range: 01/01/2012 - 08/08/2018
St. Jude Medical Defibrillator Durata Model Number 7120Q
(P950022/S049) recs
FDAs analysis of the risks associated with surgical repair of
hernias, as referenced on FDAs Hernia Surgical Mesh Implants
webpage
K152304 - Tritanium PL Cage
Akorn NY, NJ, IL and Switzerland 483, EIR and corr 05/01/2018
- 08/09/2018 - see attached
Flashback Tech communications with FDA 1) the de novo approval

for CipherOx CRI tablet 0020 decision date 12/21/2016 and 2)
510K notification for the CipherOx CRI M1 (510(k) number
K173929 7/24/2018
FDA FAERS Case IDs: 15059926 and 14946855
CATALENT, ST PETERSBURG, FL - EIR 03/03/2016 - 03/20/2016
Dow Silicones Co, MI EIR corr May 2017 inspection
Harman Finochem Ltd., India Insp recs
General Mills - MN, EIR and 483 02/20/2017 - 04/20/2017
Genral Mills -Alberquerque, NM, EIR and 483 04/01/2018 -
06/01/2018-first party
P170004 Review team's memo and admin recs
General Mills Hannibal, MO -EIR and 483 09/12/2017 - 11/12/2017
first party
483's Spaulding Clin 02/02/2017 West Bend WI GE Med Sys
06/14/2018 Wakesha WI NAMSA 05/18/2018 Minneapolis MN
Bbraun Introcan 510k K021904 July 3, 2002
NDA 009190- LIPIODOL FDA review summary for the approved orphan
indication (PAS Supplement S-024)
Epigenomics AG Pre-IDE I100944 recs
General Mills Milwaukee, WI - EIR and 483 10/14/2017 -
12/14/2017 first party
General Mills , Great Falls, MT - EIR and 483 05/12/2018 -
07/12/2018 first party
General Mills Carson, CA - 483 and EIR 06/17/2018 - 08/10/2018
first party
K180222
Reports or studies on the false positive rates for the
PharmCheck Sweat Patch
K142292
Zenzedi and Evekeo approval recs
MasterControl (SOW) etc
Pfizerpen Labeling and AL
Miconazole nitrate Dexamethasone acetate Tobramycin sulfate

Tetracosactide Loteprednol Pentosan polysulfate line listings
NDA 021077
MasterControl price lists
Zhejiang Huahai Pharm(Duqiao, China) Insp report
2017-10740 2018-3376 2018-3084 2018-3609 2018-3700 2018-3742
2018-4008 2018-4378 2018-4591 2017-1849
FOIA log PolarityTE and SkinTE
FOIA logs Polarityte, Inc
SBOA for ANDA A075666 - Hydrocortisone Valerate Cream
Docs signed by Sylvie Pancheri for Sanofi
SBA NDA 208623, Galafold from Amicus Therapeutics
Corr between the FDA, Mylan and Pfizer re:shortage of U.S.
EpiPen and Adrenaclick
IND 123557 Benfotiamine AL
K091971
Zhejiang Huahai Pharm EIRs
DEPEN (NDA# N019854) PKG insert
Tadalafil PDUFA date
Zolpidem Labeling Supplement (CBE) LTR
Voltarenm FAERS data see attached
Davis Chocolate Deco Chem 2018 EIR Mishawaka, IN
DEN170052
Monthly FOIA Logs 1/1/18 to present
483s in the attached
Recs re: extension of compliance dates of new nutrition facts
and supplemental facts label final rule
DEN160047
EIR Capsugel Greenwood, SC Dec 2016
Microvention EIR 2016 Tustin, CA
Nexgen Pharma CA, CO, TX 483, recalls, list of reportable food
registry
(FURLS) Winning bid proposal and solicitation
Medwatch reports HPV 9 (Gardasil) see attached
K173510
K180472
FOIA Log CFSAN July 2018
Emails FDA employees Adamma Mba-Jonas or Christ Jankosky that

include the words "HPV" "POTS" or "CFS" or "CRPS" etc.
BLA 125554, supplement 34.
TEEL PLASTICS, BARABOO, WI - EIR, 483, RECALLS 09/30/2013 -
01/19/2018
PMTA 8/1/16 - 3/31/18
EIR Belcher Pharm Largo, FL
Consumer complaints, inspection records, 483 Maplehurst
Bakeries Brownsburg, IN
Complaints, inspections, recalls, investigations, or
enforcement actions Innovative Intrathecal Solutions Murrieta,
CA
K150869
K172431
2014-6692
K152341
Investigation into the link between dog foods and dilated
cardiomyopathy
2015-4108
12 ISR case reports. Please see attached
CPT1800306
Retail inspection reports/lists prepared by FDA between 1/1/18-
8/1/18
2018-5121
EIR Dr. Jason Lang FEI #: 3012217287 Orlando, Florida

Insp list 08/15/2017 - 08/15/2018
Northgate Gonzalez listed as consignee, importer of record, or
FSVP importer
CPT1800876-BY
K090140 internal review file
K121057 internal review files
NDA 022272
K121629 internal review file
SE reviews, first party - See attached request
Ron ANDIO DBA PATRON FARMS MIDDLEFIELD OHIO bill of lading
Sucralose FAP
K000855 -internal reviews
K000855 -- internal reviews
K043509 -internal reviews
Gelsons (CA) and Gelson's (CA) FSVP importer info
Adverse events influenza vaccines and nephrotic syndrome
relapse and OCOD@fda.hhs.gov emails
Zimmer Biomet EIRS's see attached
483 Aditya Samal Sugarland, TX 2017
Rapp Medical audit Michigan Sept 7 2016

FDA minimum requirements about mandated training"Axium
Neurostimulator training program"
FDA response ltrs to the attached August 24, 2016 letter from
Senators Grassley, Leahy, Klobuchar, Blumenthal, and Johnson
US Pain Foundation docs
Fermic s.a. de c.v., EIR Iztapalapa, Mexico 2016
Case IDs: 12798775 12859486 13283739 13299689 13313328 13856094
14184085 14519597
COVANCE, EVANSVILLE, IN - EIR, CORR, EXHIBITS ETC
Michael A. Adams et al., "Guidance Document for Lead in
Shellfish" (1993), as referenced in 58 Fed. Reg. 48368 (Sept.
15, 1993). ETC
Korlym adverse events with reporter
SBA Galafold (NDA208623)
SBA Marcaine Spinal NDA # 018692 1984
NDA 21018, Humalog 50/50 supplement
SBOA, labels and PI THEOPHYLLINE
Jason Pharmaceuticals Raw Material Warehouse EIR Arbutus, MD
2016
FCN No. 1900
Action Packages for NDAs from 1997 per attached letter

PDUFA VI meeting 02/07/18 recs
483 - Southwest Bio-Labs, Inc. Las Cruces, NM
NDA 210192 SBA
Orange Book list of patents
VAERS for specific person
CAERS data
NDA file: 018166 Trasicor
EIR's Daito Pharm,, Toyama, JP 11/30/2017 Yuki Gosei Kogyo,

Iwaki JP 9/2/2016 Yuki Gosei Kogyo, Iwaki JP 11/17/2017
CPT1800713-BY copy of her own complaint
P140010, IN.PACT Admiral
TPL SE0006177, SE0006178
TPL SE0014246, SE0014221
TPL 36 SE Orders issued in May 2018
PHILIPS ELECTRONICS NORTH AMERICAN, ST LOUIS, MO HOSPIRA,
MCPHERSON, KS FOX RIDGE FARM, SOLON, IA ETC 483 02/23/2016 -
10/27/2017
TPL 64 SE Orders issued in June 2018
CALVIN KOERNER - RECS
TPL SE Orders issued in May 2018
TPL 4 Exemption SE Orders issued in June 2018
TPL for 2 Not Exempt from SE issued in May 2018
Mid York Press, Sherburne, NY EIR, 483's s
GRN No. 746
483 Actelion Pharm San Francisco, CA
483s NAMSA, Minneapolis, MN May 2018 Nov 2017
Meridian Medical Tech Brentwood, Missouri Insp Recs
PUR ATTITUDE, LLC, BOCA RATON, FL - EIR 01/01/2016 - 01/01/2018
SBA ANDA 204555
483, WL and corr Caito Foods Indianapolis, IN
TESTS OF FOOD SAMPLES, NECROPSY REPORTS, AND FINAL CONCLUSIONS
IF ANY FOR PET BIRD DEATHS ALLEGEDLY RELATED TO ZUPREEM
PARROT/BIRD FOODS.
483 Unichem Lab's API Pithampur and Roha in India

Exclusivity Summary NDA 210308 YONSA
K100858 - Lima LIO SMR Shoulder K110598 - LIma SMR Reverse
Shoulder K163397 - Lima Hybrid Glenoid System
Annual Drug Establishment Registration Status modified
Galephar Pharm Research profile codes/classes
4Life Research and BioMedical Research Labs WL, complaints
etc. Sandy, UT Immuno-Dynamics Fennimore, WI
Olympus San Jose, CA Insp recs and corr device event reports
INDOCO REMEDIES, PLANT I, INDIA - 483 01/01/2018 - 01/20/2018

SUBSTANTIAL EQUIVALENCE RPTS FOR SE0014026 AND SE14063
ALCAMI CAROLINAS CORP, CHARLESTON, SC 5/18-21/16 AMAREX,
GERMANTOWN, MD 1/15 INTEGRATED COMMERCIALIZATION SOLUTIONS
INC, BROOKS, KY 11/1416, ETC - EIRS
ETC
MYLAN LABORATORIES LTD, MUMBAI, INDIA - EIR 11/13-15/17
DIMETHYL FUMARATE ANDA 210-402 - TENTATIVE APRVL LTR 8/13/18

RPT FOR EACH CLNCL TRIAL RELIED UPON BY THE FDA WHEN APPROVING
RECOMBIVAX HB IN 1986
RPT FOR WACH CLNCL TRIAL RELIED UPON BY THE FDA WHEN APPROVING
RECOMBIVAX HB IN 1989
DEBRA PAGANO, FDA CONSULTANTS LLC CHITRA SHARMA - EMAILS
LIST OF JOB SERIES AT FDA THAT INDICATES GRADE LEVEL OF
EMPLOYEES
PHILIP MORRIS USA INC - SUBSTANTIAL EQUIVALENCE RPT SE0013711

NDA 20553
US BULK BOTANICALS - ENTRY #BON10075570
Corr between OIMT and Zimperium Copper River Info Tech re:NASA
SEWP Bid #67868 FDA CYOD HHSF223201710273W
483s Mylan Labs, Maharashtra, India Tai Heng Ind. Co.,
Shanghai, China Zhejiang Hisun Pharm, China Hospira,
McPherson, KS Apotex Research India
7/31/2018 event FDA Commissioner Scott Gottlieb and

individuals including but not limited to Donald Dempsey, Larry
Merlo, and Thomas Moriarty agenda, invitiation, notes, minutes
etc.
6/12/2018 meeting on FDA's accomplishments and priorities,
which involved Scott Gottlieb and Anna Abram etc
6/14/2018 meeting on drug pricing Scott Gottlieb and Anna Abram
etc.
6/21/2018 event on biosimilars which involved Scott Gottlieb
and Anna Abram etc.
483s issued by the Florida District Office from July 1-31, 2018
483s issued by the Kansas District Office from July 1-31, 2018
483 Janssen Research & Development Spring House, PA Alan
Kivitz, MD Duncansville, PA,
ANDA 078340
483 Foods & Cosmetics Amsar Private Ltd 07/12/2012 Indore,

India Biologics Dominique P. Germain, M.D.Ph.D.
09/26/2000Paris, France Devices Itamar Medical 01/13/2011
Caesarea, Israel Devices Pan Medical 05/10/2012 Gloucester, UK
PDUFA VI implementations progress update meeting on 07/18/2018,
which involved Scott Gottlieb and CDER Director Janet Woodcock
etc.
483s issued by the Detroit District Office from July 1-31, 2018
483 Par Pharm. 2013, 2014 and 2017 Spring Valley, NY
SBA ANDA 206077
K171120
OXYCONTIN - RECS
BIMO insp 2002 Allergan Irvine by LOS-DO
Transcripts associated with a public hearing that took place on

9/16/2008 Food Labeling Current Trends in the Use of Allergen
Advisory Labeling: Its Use, Effectiveness, and Consumer
Perception Docket No. FDA-2008-N-0429
TEVA PHARMS - PROPOFOL INVESTIGATIONS
Orphan drug designation information for sodium oxybate
SBA ANDA 090887 ANDA 091449 ANDA 200925 ANDA 201006 ANDA
201786 ANDA 202077 ANDA 202442
AL and review for Alomide (LODOXAMIDE TROMETHAMINE)
FRESENIUS KABI AUSTRIA GMBH, GRAZ, AUSTRIA - EIR 4/14-20/18
FSVP importer list C&S WHOLESALE NEW YORK (TOPS) (NY), Top
Market (NY), Top Market Llc (NY), Tops Distribution Center
(NY), Tops Markets Llc (NY), Tops Warehouse (NY) and TOPS - WNY
46 - BUFFALO
Allergan's NDA- Thyrolar NDA 016807 recs
March 1994 CDER ltr to talc dist
483s issued by CDERs International Operations Group from July
1-31, 2018
483s issued by CDERs International Operations Group from July
1-31, 2018
483s issued by the New York District Office from July 1-31,
2018:
483s issued by the New England District Office from July 1-31,
2018
Z-2251-2016 RAYCELL BEST THERATRONICS LTD RECS
483s issued by the New Jersey District Office from July 1-31,
2018:
483s issued by the Philadelphia District Office from July 1-31,
2018:
483s issued by the San Francisco District Office from July 1-
31, 2018:
483s issued by the Dallas District Office from July 1-31, 2018.
483s issued by the Seattle District Office from July 1-31,
2018:
483 issued by the Florida District Office
vendor capability statements or other docs Sources Sought

notice FDA-SS-18-5630044 (FDA Business Entity Data Services).
483s issued by the Denver District Office from July 1-31, 2018.
List of all entities that submitted a response to the Sources
Sought notice FDA-SS-18-5630044 (FDA Business Entity Data
Services).
483s issued by the Cincinnati District Office from July 1-31,
2018
TYSABRI AERS
K173675 AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing
PAR Sterile Prod Insp Recs Rochester, MI,
Meeting minutes and related materials FDA and AdvaMed
483s issued by the Baltimore District Office from July 1-31,
2018.
483s issued by CDRHs International Operations Group from July
1-31, 2018.
483's issued by the Atlanta District Office from July 1-31,
2018.
483s issued by the Minneapolis District Office from July 1-31,
2018:
483s issued by the Los Angeles District Office from July 1-31,
2018
EIR Orchid Orthopedic Solutions Oregon, Milford, CT
483s issued by the Chicago District Office from July 1-31,
2018
NDA 7513
PILGRIMS PRIDE COMMERICAL LAYER, PITTSBURG, TX INTERNATIONAL

FLAVORS & FRAGRANCES, INC, CARROLLTON, TX ETC 483
Mtg recs re: 510k Coalition between Jan. 1, 2011 and Aug. 17,
2018
483s issued by the New Orleans District Office from July 1-31,
2018.
Insp reports and adverse events SKY EAGLE HOLDINGS CORP CHINA
HEATING PADS
handpieces that are FDA cleared for the PicoPlus laser system.
The 510K is K173700
K162481 - RF1400 Active compression wrap
Food Companies registered with FDA that have Australian
addresses 01/01/2018 - 08/20/2018
Previous FOIA's with the word: aspartame
483 CSL Behring GmbH Germany Sensient Flavors UK Eurodesserts

Belgium Kedrion Spa Italy Sanofi Winthrop France etc.
Sami Labs Ltd insp recs 7/22/2011 - 7/13/2016
Tentative Approval letter Imiquimod(ANDA # 205971)
WHITEHOUSE ANALYTICAL LABORATORIES, WHITEHOUSE, NJ - EIR, 483,
RECALLS 05/23/2013 - 01/19/2018
PolarityTE recs and 483s for PolarityTE Utah
CV's Jeffrey Sincek Jennifer Bazergui Jennifer Ness Jennifer

Sheehan Jessica Pressley John Aghadia John Dan John
Sciacchitano Jon Polzine Jonathan Matrisciano Jose Perez-Soto
Joseph Duca Joseph Frost Joshua Adams Julia Avery Julia Ventura
Julie Woodbe
(CPT1400793) and (CPT1400459)
EIRs from Merz Pharma GmbH & Co., KGaA Dessau-Rosslau in
Germany 09/25/13 09/15/15 11/07/14 04/29/16 07/04/17
483s Produits Chimique Auxiliares et de Synthese SA of France,
and Alcami Co.NC and SC
Jason Pharm. insp recs MD locations
Wella Prof Blondor Soft Blonde Cream recs
EIR Philips Electronics St. Louis, MO 2017
SBA (ANDA): 209871 078854 and 090974
483 FDC Ltd's India.
LAND O LAKES, ORLAND, CA LEPRINO FOODS COMPANY, LEMOORE, CA

SIEMENS MEDICAL SOLUTIONS USA, INC MOUNTAIN VIEW, CA ETC - 483
Vericel Corp recs marketing, advertising, and/or promotion of
the following products: Carticel, MACI or Epicel for uses other
than approved (i.e. off label uses).
ANDA 090894 corr
2018-5798
2018-6438
483's Associated Milk Prod. (AMPI) in Arlington, Iowa 2013-
2018
483's Associated Milk Prod (AMPI) Blair Wisconsin 2013- 2018

2018-3315 2018-3334 2018-3371 2018-3507 2018-1991 2018-2814
2018-2815 2018-3755 2018-3799 2018-4012
FOIA logs 1/1/2017 to present concern former Health Secretary
Tom Price or U.S. Senator Johnny Isakson
K03252
K100857 first party
APLICARE, PRICHARD, WV - EIR, 483, RECALLS 05/22/2013 -
01/19/2018
FOIA log 08/13/18 -8/20/18
JUDICIAL WATCH V HHS 1:14-CV-01803-KB ACLU V HHS ADMIN FOR
CHILDREN & FAMILIES 15CV-02645 FOI DAILY LOG 2015
Entry info (Apollo Health and Beauty Care). 63148-001 63148-

002 63148-004 63148-005 63148-410 63148-411 63148-413 63148-415
63148-416 63148-418 63148-422 63148-431 63148-433 63148-434
63148-441
K112119 -- review file
August 1979 Peripheral and Central Nervous System Drugs
Advisory Committee.
483 DynaFlexSaint Ann, MO
483 Yuki Gosei Kogyo, Japan
483 Advanced Monitored Caregiving, New York, NY
FDA Registration UltraSwim Shampoo UPC: 041167340110
RECS RE PLANT-BASED ALTERNATIVE MEAT RECORDS 01/01/2016 -
01/19/2018
2006 Letter to Nancy Cook of Pet Food Institute from Sharon
Benz
IDE G170300
483 Cambridge Isotope Lab Tewksbury, MA Karyopharm
Therapeutics Newton MA,
Lymerix recs
EIR, 483 Belcher Pharm, Largo, FL
Prophase Labs/Pharmaloz Mfg Doylestown, PA
FAERS 14158728 14161065 14179664 14181078 14190333 14194817
14197750 14198282 14199149 14199976 14201863 14205882
M-M-R II - CLNCL TRIAL RECS
ADVANCED SURGICAL CONCEPTS LTD - PNEUMOLINER RECS
ACETAMINOPHEN PREPARATIONS - ISRS13294083, 13565474, 14030145,
ETC
MUSCLMASSTER, LLC, WHEAT RIDGE, CO EAGLE SMOKED SALMON, INC
GYPSUM, CO TYSON FOODS, INC CLEARFIELD, UT ETC 483
TEVA PHARMACEUTICALS USA - AZITHROMYCIN ANDA 65-419/S01/S02
LUPIN LTD - AZITHROMYCIN ANDA 65-488/S01/S02 SBA, MOR, LBLG,
ETC
SUBSTANTIAL EQUIVALENCE RPTS FOR SE0006259-60 3/22/1
ADVICE/INFORMATION REQUEST LTR FOR SE0006259 3/25/13, ETC
05/09/2017 - 08/16/2018 Gottlieb's schedule and travel
Gilead and Synthetics China recs and inspection Atripla,
Emtriva, Turvada and Letairis recs,
Nuplazid deaths 12663743 12824461 12842326 12884840 12938553
12938789 12967267 12993948 13097147 13124050 13136994 13292481
Nuplazid 13386093 13404245 13404250 13465669 13557902 13614491

13668471 13713436 13865270 13865398 13867224 13867665
483 Kyowa Hakko Bio Hofu, Japan
EIR MEDTRONIC NEUROMODULATION Minneapolis , MN 2017 55421

Biomat EIR Jul 2015 Austin, TX
K974393
AMRI Burlington EIR and 483 2015 Burlington, Mass.
AMRI Burlington EIR and 483 2016 Burlington, MA
Public Citizens July 25 and July 23, 2018 letters FDA Scott
Gottlieb recs
Emails between FDA Commissioner, Mitch Zeller, Matthew Holman
and domain address "@xxiicentury.com"
K110268
bB Biochem Laboratories, Santa Ana, CA EIR, 483 and corr 2017

Fermic s.a. de c.v.,Iztapalapa, Mexico July 2016
Belmora, Arlington, VA EIR, 483 and corr 2017
Better Health Systems, Monument, CO EIR, 483 and Corr 2014
NAMSA, Minneapolis, MN EIR, 483 and Corr 2017
JUBILANT HOLLISTERSTIER, LLC, SPOKANE, WA NORTHWEST FROZEN,

LLC DES MOINES, IA NORTHERN FISH PRODUCTS, TACOMA, WA ETC 483
K133821 K163105 K171358
Meridian Medical Tech, 483s Brentwood, MO
K121171
K111992
K140657
ANDA # 205530 SBA ACETAZOLAMIDE
K110826
Dr. Reese H. Clark Insp Recs, etc. Atlanta, Georgia,
Olympus Medical EIR 2015 Japan
Positive Power Nutrition Murrieta, CA
HOSPIRA, MCPHERSON, KS - 483 MOST RECENT 12/01/2017 -
01/19/2018
Recs with Dana Walters OSI/CDER
UNITED CATERING OPERATIONS, NEWARK, NJ AAK FOOD SERVICE,
HILLSIDE, NJ - EIR, CMPLNTS 4/10/18 TO PRESENT
ANDA # 209734 ACETAZOLAMIDE SBA
ANDA 207366 Ribavirin
Mtg recs April 2, 2015 between FDA and Essure
Mtg Recs February 3, 2016 between FDA and Essure
Meeting Rec September 14, 2016 between FDA and Essure
Recs btw FDA and Congress re: Essure
Congress and FDA recs re: 21st Century Cures Act, E-Free Act,
Ariel Graces Law H.R. 5403, MDSA 2017, MDUFA
PIMAVANSERIN AERS 14038121 13964379 14011926 ETC
PHARMATECH, DAVIE, FLORIDA EIR 2014, 2015, 2016 & 2017
FCN 1589
NDA 020687/S-020 mtg recs January 29, 2015
NDA 18859 Virazol
FAERs Lynparza Zejula Rubraca
MAF#1223 MED-400 silicone fluid
US Stem Cell Insp Recs, WL Sunrise, FL.
List of mobile medical app complaints or WL for any of those
products
Quali-Controle & Quali-Controle Francen 483 and response
Stryker products: K100887 K910132 K934094 K935237 K944025
K952681 K954726 K962075
K161434
K163255
Danco Lab REMS Assessment Reports
Immune Globulin (Human), batch A1GLB01272 adverse events
TAYCA CORPORATION 483 Japan
ADMA Biologics EIR Boca Raton, Fl
Robert Califf May 1, 2015 to April 1, 2016 recs re: REMS ETASU
Chanel No. 5 Bath Powder VCRP recs
Jeff Shuren financial disclosure, conflict of interest forms
and waiver
TRALI - Outcome of investigation of deadly reaction to platelet
transfusion
Boehrigner Ingelheim RCV & Co KG, Germany, Nov 2014 483, EIR
BAXALTA, THOUSAND OAKS, CA UNILEVER FOODSOLUTIONS, CORONA, CA
ECA MEDICAL INSTRUMENTS, NEWBURY PARK, CA - 483
SE0014435 RAW Organic
Astellas Pharma Northbrook, IL EIR, 483 and corr
Talc docs
Epidiolex (cannabidiol) -NDA
Clobazam (generic drug) Tentative AL
Estradiol ANDA No. 206685 AL
Deferasirox ANDA 208882 AL
Tianaptine recs
Dec 7, 2017 recs to CDRH employees Don St. Pierre and Courtney
Lias
Korlym (mifepristone) AERS 15043804 14974167 14964628 14727528
14949624 14941131 14941120 14930660 14892923 14871686 14848178
14827070
SOUTHERN AIRE SEAFOOD INC, IRVINGTON, AL ARMADA NUTRITION,
SPRING HILL, TN RICH PRODUCTS CORPORATION, MORRISTOWN, TN ETC
483 11/01/2016 - 11/22/2017
FOIA log dating back to 2006 bisphenol-A and/or BPA

FDA employess government credit cards
ANDA 090894 Emtricitabine and Tenofovir Disoproxil Fumarate
routing summary
IVANTIS Irvine, CA Insp recs
IVANTIS Irvine, CA 2015 insp recs
CPPs issued on Aug 21, 2018
Inspection by Ms. Tonia Bernard
K884790 QUALTEX NEUROLOK SURGICAL SPONGE
MINIPRESS recs
Athenex Pharma Clarence, NY insp recs compounding recs
vasopressin
2015-8245
Emails 01/01/2017 - 06/30/2017 michael@smallbatchpets.com
relating to pet food recs
Email recs Tracey.Hatch@radfood.com and
Janice.Rizzi@radfood.com relating to pet food recs
K101356
PharMEDium Lake Forest, IL 483 and EIR 2016 and2018
K173327
NDA 020449 Taxotere
Worldwide Clinical Trials Morrisville, NC 483 and EIR 2013-2018

K181085
INDIVIDUAL RECS
K062274
CORR BETWEEN JOHN CARREYROU & FDA 3/15 TO 3/16
LifeSouth Community Blood Centers Gainesville, FL EIR 2016
2018 MULTISTATE OUTBREAK OF E COLI LINKED TO ROMAINE LETTUCE
FROM THE YUMA GROWING REGION
2017-9273 certified copy
IPOL IN 1990
ETC
AMERICAN INTERNATIONAL INDUSTRIES OF CALIFORNIA - CMPLNTS,
CORR, INVESTIGATIONS, ETC
SPINAL DISC REPLACEMENT - RECS LAST 5 YRS
DRUG CANDIDATES WHO HAVE RECEIVED RARE PEDIATRIC DISEASE
DESIGNATION
K141770
RECS RE MERCK PHARMACEUTICALS AND FDA RE MUSCLE-RELATED AERS
INVOLVING SIMVASTATIN 01/01/2008 - 12/31/2012
IND 57-403
DEXCOM, INC, SAN DIEGO, CA MESA, AZ - INSPECTION RECS, CORR
01/01/2018 - 08/24/2018
Summary Review or Summary Memo filed under TSI No. 1781 (Safety
001781
NDA 209191 SUMMARY REVIEW
NDA 209191 APPROVAL LETTER, LABELING
NDA 209191
FCN 647
PEDIATRIC ADVISORY COMMITTEE, ENDOCRINOLOGIC AND METABOLIC
DRUGS ADVISORY COMMITTEE 05/11/2018 - 05/11/2018
K172740, K172740/S001 ETC
FINAL POSTMARKET SURVEILLANCE REPORTS 01/01/2013 - 08/23/2018

RECS RE INVESTIGATION SPRING PASTA SALAD SALMONELLA SAN DIEGO,
ARIZONA OUTBREAK, FOIA REQUESTS, GENETIC TESTING 01/01/2018 -
08/24/2018
CORR REGARDING ERIC POTRATZ 4/08 TO 4/15
K181749 FIRST PARTY
YANCEY'S FANCY, INC FSVP IMPORTER RECS 01/01/2017 - 08/24/2018

NDA 022059, S 017
RADAGAST PET FOOD, PORTLAND, OR - INSPECTION RECS 01/01/2017 -
08/24/2018
2017-576 2017-471 2017-6699 2017-10359
ANDA 087954 ANDA 087955
33 FAERS case numbers
FDA REPLY TO ZIMMER BIOMET 2016 483 RESPONSE ETC 01/01/2016 -
08/27/2018
FOIA RELEASED RECS MEDTRONIC SYNCHROMED ETC 01/01/1985 -
01/01/2006=
ETEX CORP - BETA-BSM K090242, ETEX CORP - GAMMA-BSM K090242,
SKELETAL KINETICS LLC - CALLOS K030554
Line List for Salmonella San Diego and Arizona illness outbreak
CURRENT LIST OF SUBSTANCES NOMINATED FOR 503A BULK LIST AND
THEIR NOMINATORS ETC 12/04/2013 - 08/27/2018
WRIGHT FOODS, TROY, NC - EIR 02/01/2016 - 02/09/2016
DESI 11520
HUMIRA AERS
BOSTON SCIENTIFIC, SAN JOSE, CA - EIR 02/01/2018 - 05/01/2018

ACTELION PHARMACEUTICALS, SOUTH SAN FRANCISCO, CA - EIR, 483,
CORR 2/14/14
K954331
BREAST IMPLANTS - MDRS
ETEX CORP - BETA-BSM K090242, ETEX CORP - GAMMA-BSA K090242,
ETEX CORP - ALPHA-BSM K091729 ETC
LAP-BAND ADJUSTABLE GASTRIC BANDING SYS P00008 - ANNUAL
PROGRESS RPTS, PMA, SUMMARIES, ETC
ABBVIE, INC, NORTH CHICAGO, IL - EIR 06/01/2018 - 08/27/2018

BAIYUNSHAN HEJIGONG PHARMACEUTICAL FACTORY, CHINA - 483
05/22/2017 - 05/25/2017
ALCHYMARS ICM SM PRIVATE LIMITED, INDIA - 483 09/11/2017 -
09/15/2017
JASON AUNGST, KENNETH BARRY DELCLOS EMAILS RE CLARITY
01/15/2018 - 03/07/2018
2017 ANNUAL RPTS SUBMITTED BY RESEARCH FACILITIES TO THE
NATIONAL INSTITUTES OF HEALTH'S OFFICE OF LABORATORY ANIMAL
WELFARE
CORR SENT OR RECEIVED BY CDC WMPLOYEES THAT INCLUDE THE WORDS
NUCLEAR, NUKE, GRAND ROUNDS, ETC 12/1/17 TO 1/29/18
CANCELLED BRIEFING ON HOW AMERICANS SHOULD PREPARE FOR NUCLEAR
WAR
NATIONAL VACCINE INJURY COMPENSATION PROGRAM (NVICP) -
INDIVIUDAL RECS
NATIONAL VACCINE INJURY COMPENSATION PROGRAM (NVICP) -
INDIVIUDAL RECS
LION NUTRITION DOCS
CAERS 2018-CFS-006610, 2018-CFS-006612, 2018-CFS-006613, ETC

2018-2824 2018-3273 2018-3308 etc
VISBIOME - CAERS
REPORTS, DATA RE CYTOXICITY, MECHANICAL PROPERTIES, ETC K162572

AAR, JETBLUE AIRWAYS, ETC - FORMS 2371A, 2371B 01/01/2016 -
08/25/2018
TRANSCRIPT VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY
COMMITTEE MEETING 9/19/12
SUMMARY TEST RESULTS MILK/DAIRY POWDER SAMPLING ASSIGNMENTS
01/01/2010 - 08/27/2018
ZIMMER BIOMET WARNING LETTER 08/23/2018 - 08/27/2018
UNREDACTED SCIENTIFIC AND MEDICAL EVALUATION DOCUMENT PREPARED

BY HHS AND PROVIDED TO DEA RE EPIDOLEX 08/17/2009 - 08/27/2018
FOIA LOGS 08/20/18 TO 8/27/18 EXCEL
CASE REPORT 13646615
NDA 020255, 020439, 020402, ETC

WALLCUR LLC - PRACTI RECALL 12/14
CORR RE CAFFEINE BETWEEN FDA CFSAN AND MARS, INC, THE WRIGLEY
COMPANY, COCA-COLA ETC 08/06/2013 - 12/31/2017
SPINRAZA 14760858 14353577 14365412 13689020
CONTAINER, CARTON LABEL OF 14 DAY TITRATION BLISTER PACK AND
CARTON NDA 022535, ESBRIET
MDR FOR 15548-0057
16-00821 FOIA, 16-00800 FOIA, 213 LOG, 2104 LOG, 2015 LOG, LYME
TICK DISEASE RPT
CMPLNT FORM
K923368 K023351
PURETEK CORP - CMPLNTS, INVESTIGATION 1/14 TO PRESENT
GOURMET GARDENS, JACKSONVILLE, TX - INSP
MRI INFO
UNILAB, FORT LAUDERDALE, FL - EIR 2017
DEL MONTE FRESH PRODUCE INC - 2018 CYCLOSPORA OUTBREAK,
TESTING, INSP
AJINOMOTO TOYO FROZEN NOODLES INC, PORTLAND, OR - INVESTIGATION
1/16 TO PRESENT
THE CLEVELAND CLINIC THE FOUNDATION FOR FEMALE HEALTH

AWARENESS STANFORD UNIV WASHINGTON HOSPITAL CTR WAKE FOREST
BAPTIST MEDICAL CTR CHRIST HOSP BROWN MEDICAL - CLNCL TRIAL
OF VAGINAL LASER THERAPY
FLUZONE - CLNCL TRIAL APRVLS
PYRAZINE SPECIALTIES, ELLENWOOD, GA - EIR 11/01/2017 -
02/01/2017
UNITED SAFETY AGENTS RECS FSVP 08/15/2018 - 09/15/2018
FDA TOBACCO PRODUCT LISTINGS KURE CORPORATION-ARBORETUM ETC

K132276
EVANGERS DOG & AT FOOD COMPANY INC, WHEELING, IL - 483, EIR,
WARNING LETTER ETC 01/01/2008 - 12/31/2008
AKORN PHARMACEUTICALS INC, SOMERSET, NJ AMITYVILLE, NY ETC -
483 01/01/2018 - 09/30/2018
LIDODERM ANDA 200-675 APRVL
DEN130031
RECS RELEASED IN RESPONSE TO FOIA BY PIERCE G. HUNTER
11/01/2013 - 08/29/2018
CVM DELETED TWEETS
CMPLNT 153418
HILL DERMACEUTICALS INC, SANFORD, FL - EIR 5/8-18/18
BAXTER HEALTHCARE CORP - MINICAP W/POVIDONE IODINE SOLUTION
2/24/15
RECORDS TO POINTE72 ASSET MANAGEMENT RE MIMEDX GROUP INC
FOIA LOGS POLARITYTE, SKINGTE 01/01/2017 - 08/30/2018
SPREADSHEET OF PUBLICLY AVAILABLE DATA POINTS FOR ALL NOTICES
OF FDA ACTION DURING JUNE 2018
LETTERS, MEMO RECEIVED BY SCOTT GOTTLIEB FROM FDA STAFF RE
RIGHT TO TRY BILLS, RESPONSES 01/01/2018 - 08/27/2018
TITANIUM HIP TOOL K051032, HIP TOOL IMPLANT K022139, TITANIUM
HIP TOOL LOCKING PLATE K072175
Michael Hudson, Michael Ireland, Michele Glendenning, ETC CV
MEDWATCH REPORTS
WRIGHT MEDICAL PROFEMUR PLUS COCR MODULAR NECK, PHAC1254 -
MEDWATCH, CORR ETC 01/01/2009 - 08/28/2018
SPINRAZA AERS
XML file for the FDA's recall data set from 2015-2017
Opdivo BLA 125554, supplement 67
List of Temporary Marketing Permits granted under the me-too

suggestion to participate in the Canned Tuna Drained Weight
temporary marketing permit published in the Federal Register on
Mar 7, 2016, Docket No. FDA -2012-P-1189
K131493
NDA 011685 NDA 012802
8 ANDA APPROVAL LETTERS

KEEGAN KUHN, KIP ANDERSON, AUM FILMS, COWSPIRACY, WHAT THE
HEALTH - RECS
MAC MEDICAL, MILLSTADT, IL - EIR, 483 01/01/2012 - 08/29/2018

NDA 19631 SBA
SENTIO BIOSCIENCES LLC, MARYLAND HEIGHTS, MO HILAND FAIRY
FOODS COMPANY, OMAHA, NE - 483 07/07/2011 - 05/19/2017
LIVA HEALTHCARE, VADODARA, GUJARAT, INDIA - 483 08/22/2018 -
08/28/2018
SUMMARY OF AERS MILBEMYCIN 01/01/2015 - 12/31/2017
PRODUITS CHIMIQUE AUXILIARES ET DE SYNTHESE SA, FRANCE 483
08/01/2013 - 08/28/2018
Records of the FDA, CDER, IND Federal Marijuana Patients ETC

CASE REPORTS KORLYM
CITIZEN PETITION NATIONAL MILK PRODUCERS FEDERATION 75P-0121,

RECS RE INDUSTRY REQUESTS FOR REFUNDS OF ANNUAL PDUFA
PRODUCT/PROGRAM FEES ETC
CORR REGARDING AMERICANS FOR MEDICAL PROGRESS, FOUNDATION FOR
BIOMEDICAL RESEARCH, NATL ASSOC FOR BIOMEDICAL RESEARCH
ZIMMER EIR, AGENDA, MINUTES ETC RE REGULATORY MEETING ON
4/27/17, ETC 03/01/2017 - 08/29/2018
LIVA PHARMACEUTICAL, INDIA - 493 08/01/2018 - 08/29/2018
33 insulin case reports
FCN 1889
FCN 1900
2016-9715
Summary Basis of Approval for NDA 210997
CTP Memorandum, Use of Surrogate Tobacco Products in SE
Reports, final signature date September 19, 2016.
K922123
Two SOPs from FDA/CBER/ Office of Compliance for Biologics
Quality/DBSQC
VCRP DATABASE RECS
NDA 209311
P860004 ETC
LETTER TO MR WILLIAM B MILLER, JAMES RIVER CORPORATION, BERLIN,
NH FROM BL MICHELL, CFSAN 8/26/86
RECS, COMM RE APPROVAL, INSPECTIONS OF ZHEJIANG HUAHAI
PHARMACEUTICAL CO LTD VALSARTAN 01/01/2015 - 08/30/2018
CADILA PHARMA, LIVA, INDIA - 483 08/15/2018 - 09/02/2018
K173004
VISINE LR NDA 19407 AND SUPPLEMENTS
RECS RELEASED UNDER FOIA MEDTRONIC NEUROMODULATION FACILITY
01/01/2013 - 01/01/2014
RECS ISSUED BY REMS COMPLIANCE TEAM NDA 020687
LIST OF INSPECTIONS
CPT1700738
NDA 208552 SBA
NDA 018471 AND SUPPLEMENTS SBA
Any or all documents relating to correspondence concerning
the composition of products identified as"milk protein
concentrate."
Consumer complaint report records associated with struvite in
canned salmon 01/01/2013 - 08/30/2018
K01372
Office of Orphan Products Developments (OOPD) designation of
Gilead Sciences' (formerly Corus Pharma) Cayston (aztreonam for
inhalation solution)
Product approval documentation for Ciprodex
CPT1400793 CPT1400459
Biocompatibility testing and nonclinical testing information

for the Synchrony intraocular lens, PMA application, excluding
attachments of original test reports and protocols
Biocompatibility testing and nonclinical testing information

for the CrystaLens PMA application (P030002), excluding
attachments of original test reports and protocols
CHINESE DRUG FIRM APPROVALS 01/01/2013 - 12/31/2017
K152178
FAERs 14887420 14887398 14760847 etc
PROVISIONS INTERNATIONAL, WHITE RIVER JUNCTION, VT - INSPECTION
REPORT 10/02/2014 - 10/02/2014
RECS RE ENVANGER'S DOUG AND CAT FOOD CO, INC, NUTRIPACK LLC
01/01/2000 - 08/30/2018
DRUG MASTER FILE DATA 01/01/2018 - 07/31/2018
BBCOS, SRL, CHERASCO, ITALRY - 483 06/19/2017 - 06/23/2017
FAERS 14877142 14877163 14338240 ETC
INTAS PHARMACEUTICALS LIMITED, INDIA MSD INTERNATIONAL GMBH,
SINGAPORE DASAMI LAB PRIVATE LIMITED, INDIA - 483 06/01/2018 -
06/30/2018
ASAHI KASEI FINECHEM, JAPAN - 483 06/01/2018 - 06/30/2018
KAKEN PHARMACEUTICAL, JAPAN - 483 06/01/2018 - 06/30/2018
K152319
NIPPON KAYAKU CO LTD, JAPAN - 483 07/01/2018 - 07/31/2018
DAARTS TSI Evaluation on the drug Nuplazid (Pimavanserin)
K140933
Approval letter informing Medtronic that its S056 P860004 PMA
supplement application had been approved on 09/12/2003
NDA 12373
MARS PETCARE US, ALLENTOWN, PA - 482, 483, LAB REPORTS ETC
01/01/2007 - 12/31/2007
INDIVIDUAL RECS 10/18/2017 - 01/18/2018
SUN PHARMA, HALOL, INDIA 483 08/01/2018 - 09/02/2018
CDER OSI RECS DANCO LABORATORIES 09/27/2007 - 08/31/2018
2017-8686
MEDICAL DEVICE ADVERSE EVENTS, APPROVALS 01/01/2007 -
12/31/2017
ELYEA (AFIBERCEPT) FAERS 1/12 TO 9/28/18
CORR RE MR NUNES 9/25/17

CMPLNTS TITANIUM HEART VALVE LEAK
DISPENSARY IN NEW YORK
FCN 380
TEVA PHARMACEUTICALS USA - EPIPEN APRVL 8/16/18
INDIVIDUAL RECS
2004 DEA REQUEST SENT TO HHS ON HYDROCODONE PETITION \
MINUTES ADVISORY COMMITTEE MTG
DKT FDA 2011P-0671
FLU VACCINE - INDIVIDUAL RECS
ACELLA PHARMACEUTICALS LLC - NEURPATH B RECS 2009 TO PRESENT

PAMLAB LLC - METANX RECS 2008 TO PRESENT
MERIDIAN TECHNOLOGIES, PFIZER - 483, EIR RE WARNING LETTER
01/01/2013 - 08/31/2018
P080025
ZIMMER BIOMET - EIR, 483 ETC 06/14/2018 - 08/31/2018
NDA 203312 REPORT
K172790 K160598 K140273 ETC
14814906 14676222 14724235 ETC AERS
log of all FOIA requests related to CorMedix, Inc 01/01/2017 -
09/05/2018
ADVERSE INCIDENTS ROLLATORS, WALKERS
All FDA positions (including series and titles) covered for
union membership under the bargaining union contract(s) with
FDA.
NDA 017588
GRN 000749
SPREADSHEET OF DMF 01/01/2017 - 12/31/2017
SUNFOOD, EL CAJON, CA - INSPECTION RECS 08/08/2014 - 02/15/2015
CSL PLASMA, INC, S MILWAUKEE, WI - EIR 07/01/2017 - 07/31/2017

SUBOXONE CHEMISTRY REVIEW
ETHICON 2006 RECALL RECS
483, EIR, RESPONSE RELEASED UNDER FOIA 07/31/2018 - 09/01/2018
CHONGQING PHARMA RESEARCH INSTITUTE 483 11/01/2017 - 09/01/2018

PREVIOUSLY RELEASED EIR, 483 08/01/2018 - 08/31/2018
LISTS OF INSPECTIONS 07/01/2018 - 08/31/2018
JOHNNIE WOODSON, WOODSON DERMATOLOGY/CLINICAL STUDIES GROUP,
HENDERSON, NV 483 02/01/2016 - 09/03/2018
JAPANESE FOOD
ADVERSE EVENT REPORTS CONTRACEPTIVE DRUGS 01/01/1968 -
12/31/2016
SUNIL DHAWAN EAST BAY DERM MED GRP, FREMONT, CA- 483 07/01/2010
- 09/03/2018
References, Notes and Documentation pertaining to the FDA
Review and Approval of the NDA for Epidiolex Solution
2018-3846, 2018-3890, 2018-3891,ETC
PREVIOUSLY RELEASED 483, RESPONSE, EIR AUGUST 2018
LISTS OF INSPECTIONS AUGUST 2018
FOIA LOGS AUGUST 2018 EXCEL
LOG OF 483S RELEASED UNDER FOIA AUGUST 2018
MIFEPRISTONE AERS
K173553
K172604 CW170012
INDOCO REMEDIES, GOA, INDIA - 483 01/15/2018 - 01/19/2018
INDIVIDUAL RECS
FCN 1801
NDA 050587 Suppl-80
K093633 K083050 K121975 etc
MEDTRONIC PUERTO RICO, MALAYSIA - EIR 07/01/2014 - 05/31/2017

FOIA LOGS EXCEL 08/27/18 - 9/03/18
MEDWATCH REPORTS 8081646 8140506 8169184 ETC
TEST RESULTS OTC EYE WASH SAMPLES 09/22/2016 - 09/05/2018
Approved Suitability Petition copy for Metoprolol Tartrate
Tablets Approval Letter of Metoprolol Tartrate Tablets
LUPIN, INDIA 483 08/20/2018 - 09/04/2018
NDA 011665
CSR COSMETICS SOLUTIONS, BARRIE, ONTARIO, CANADA 483 01/01/2018
- 09/06/2018
UNITED EXCHANGE CORP SAMPLE RESULTS OTC EYEWASH RECALL
09/28/2016 - 09/05/2018
NDA 018554 NDA 020498 NDA 020169 ETC

EVER APPROVED DRUG LIST 01/01/1938 - 09/05/2018
AMERICAN RED CROSS, SPRINGFIELD, MA ETC EIR
SUN PHARMA, HALOL, INDIA 483 AUGUST 2018
AERS MONSTER DRINK ETC 01/01/1990 - 09/01/2018
SUN, HALOL, INDIA - 483 01/01/2017 - 09/07/2018
2013-706
K132987
INDIVIUDAL RECS - CMPLNT
PM OXYGEN SERVICES LLC, PM OXYGEN SERVICES INC, CO - EIRS,
483S, WARNING LTRS 1/1/98 TO PRESENT
HYDROCODONE COMBINATION PRODUCTS - SCIENTIFIC AND MEDICAL
EVALUATION, RESCHEDULING, ETC
NOMINATION OF BIOIDENTICAL HORMONES TO THE DEMONSTABLY
DIFFICULT TO COMPOUND LIST 2007 TO PRESENT
WARNING LTRS TO COMPOUNDING PHARMACIES PROHIBITING THE
COMPOUNDING OF MEIDCATIONS WITH ESTRIOL WITHOUT AN
INVESTIGATIONAL NEW DRUG APPLICATION
LOPEZ GANZALEZ SANTANA CORP (DBA DOMEL, DERMIXX), RIO PEIDRAS,
PR - EIR 1/31/17-2/10/17
KELLOGG CORR REGARDING NUTRITIONAL FACTS LBLG INDIVIDUAL RECS

TEVA PARENTERAL MEDICINES INC, TEVA PHARMACEUTICALS USA INC -
ANDA 90-589 APVRL RECS
IND BB-IND 9188, BB-IND 8235
ISummary Review or Summary Memo filed under TSI No. 1579

(Safety-001579) regarding PDE5 inhibitors and skin melanomas
K062356
K122698 K110599
K023914 K090970
WEST DULUTH DISTRIBUTION DBA CHK NUTRTION, DULUTH, MN - EIR
09/01/2016 - 09/06/2018
RECS RE 2016 INVESTIGATION OF B CEPACIA CONTAMINATION OF DIOCTO
LIQUID PHARMATECH
K152635
RADNET RECS RE BILLING PRACTICES 01/01/2014 - 09/01/2018
ARRHYTMIA IN PASSPORT SERIES PATIENT MONITORS SHENZHEN MINDRAY
BIOMEDICAL ELECTRONICS CO LTD PERFORMANCE DATA 09/04/2018 -
10/31/2018
SLIDE PRESENTATIONS AMERICAN SOCIETY OF CLINICAL
PSYCHOPHARMACOLOGY MEETING 01/01/2018 - 06/01/2018
The initial experimental report of Contract 223-75-2030

investigating the Psychotoxicity of Selected Food Additives and
Related Compounds (MSG and calcium carrageenan). (2) The cover
memo for the initial report, dated 3/7/77
NDA OXYTOCIN, PITOCIN, SYNTOCINON
RECS RE CAFFEINE INTAKE BY US POPULATION LASZLO SOMOGYI
CAFFEINE AERS 08/01/2010 - 01/11/2018
RITUXAN LABEL RECS
The CDER's Site Surveillance Inspection list as discussed in
MAPP 5014.1
rRecords and testing results for ZYN nicotine pouches that

pertain to the product's levels of tobacco-specific
nitrosamines and harmful and potentially harmful constituents
Clinical review for Eloctate from the initial BLA approval on
June 6, 2014
NDA 018932 SBA
ENFORCEMENT REPORTS ETC 10/01/2011 - 09/05/2018
Quality Assurance Profile or GMP Inspection History for: SGS
Canada, Inc. 6490 Vipond Dr, Mississauga, Ontario L5T 1W8,
Canada (CAN) DUNS #: 203668041 FEI #: 3007632373
FAERS 15072711 15058363 14975450 ETC
STELARA AERS
K053417
CORR BETWEEN FDA AND ADVANCED BIOTECH, ETC RE DETERMINATION

THAT THE COMPANIES USE A NATURAL FERMENTATION PROCESS FOR THE
MANUFACTURE OF VANILLIN THAT RESULTS IN A NATURAL PRODUCT
SONOVA, SWITZERLAND - EIR, 483, WARNING LETTERS 01/01/2017 -
01/22/2018
ABBVIE INC, NORTH CHICAGO, IL - EIR, EXHIBITS, ATTACHMENTS
11/27/2017 - 08/31/2018
TAPEMARK COMPANY, SAINT PAUL, MN ETC 483 03/07/2017 -
05/18/2018
EVER APPROVED LIST
LUFTHANSA TECHNIK - AIRCRAFT MAINTENANCE, SAN JUAN, PR - CERT
OF SANITARY CONSTRUCTION, 483
K050094
RFP-12-223-SOL-0016
GENETECH, SAN DIEGO, CA - 483 06/18/2018 - 06/22/2018
COLOPLAST VIRTUE MALE SLING - COMM, ,CORR, DATA ETC 01/01/2007
- 09/04/2018
ACTAVIS INC, EDISON, NJ ETC 483 12/05/2016 - 05/07/2018
FAERS 15147330 15147342 ADDITIONAL INFO
PEDIATRIC ADVISORY COMMITTEE COMMENTS 10/28/2010 - 01/06/2011

PURINA ANIMAL NUTRITION LLC, RICHMOND, IN ETC 483 05/17/2005 -
04/12/2017
TEVA - FDA DECISION AND ANALYSIS GRANTING 180-DAYS MARKETING
EXCLUSIVITY FOR ANDA 90-141
DOW PHARM - ALTRENO (TRETINOIN) NDA 209-353 SBA, MOR, LBLG, ETC
FLUARIX FOR SIX MONTH OLD BABIES
APRICUS BIOSCIENCES INC - VITAROS RECS
VIVA-JR K973628-A004, SELECTRA PRO M K102647, SELECTRA PRO S
K102647-A002, ETC - HEALTH HAZARD EVALUATION/HEALTH RISK
ASSESSMENT
TEMPORARY AND PERMANENT GRADE PROMOTION STATISTICS 2018
POULTRY HATCHERIES - EIRS, 483S
MIMEDX - EIR, 483, WARNING LETTER ETC 01/01/2017 - 01/22/2018

US SMOKELESS TOBACCO CO - SUBSTANTIAL EQUIVALENCE RPTS
SE0014544, SE0014545, SE0014546, ETC
PAXVAX INC - VIVOTIF (TYPHOID LIVE ORAL TY21A VACCINE) VAERS

FDA ASSESSMENT OF THE TERM NATURAL CLAIM ON FOOD LABELS -
MTGS, PHONE CALLS, EMAILS, ETC 1/16 TO PRESENT
REGADENOSON, TECHNETIUM, NARCAN - AERS (CERTIFIED)
FDA RE-EVALUATION OF THE TERM HEALTHY ON LABELS - RECS 1/16 TO
PRESENT
IMPAX, HAYWARD, CA - EIR, 483, WARNING LETTER ETC 01/01/2017 -
01/22/2018
RECS RE VARIANCE NUMBER 2015-V-2143 EXAMINER XAC CABINET XRAY
CABINET
INSERT DEPO-TESTOSTERONE - NDA 085635/S-0040
: K001237, K090970, K023914, ETC
CONTRACTS FOR PURCHASE OR TRANSFER OF LATEX PRODUCTS FISHER

SCIENTIFIC COMPANY L.L.C.DUNS#: 1408673 GOVERNMENT SCIENTIFIC
SOURCE, INC.DUNS#: 785807611 LAKOTA ENTERPRISES, INC.DUNS#:
2924806 ETC
K921470 K921471 FIRST PARTY
Txt and PDF files of historic Orange Book publications from
2010 to 2018
K173560
2018-6912
WILLY ORANTES, YIYUE ZHANG, YOUNG KIM, ETC CV
Brentley Collins, Brian Campbell, Capri Woolridge, ETC CV
EMAILS WITH WORD CLARIFY TO OR FROM KENNETH BARRY DECLOSE,
DANIEL DOERGE 01/01/2014 - 02/15/2014
IRB AUDIT REQUESTING ESIGNATURE 09/01/2015 - 08/31/2018
2017-10458 FOLLOW UP RECS RE TRAINING ETC 01/01/2018 -
09/04/2018
AKORN INC - INSPECTION RECS ETC
P100003, DOCKET, INSPECTION RECS ETC
GILEAD SCIENCES PRIOR APPROVAL SUPPLEMENT TENOFOVIR
RECS RE CHLORHEXIDINE
PATHEON YK LIMITED, GREAT BRITAIN - EIR 11/10/2016 - 12/06/2016

Study/studies or any documentation used to prove the above
referenced FDA claim that linear GBCAs are retained for a
longer time than macrocyclic GBCAs
INVUITY, INC, SAN FRANCISCO, CA CHARLES RIVER LABORATORIES

PRECLINICAL SERVICES, RENO, NV - 483 01/23/2013 - 06/15/2018
THIEN HUONG FOOD JOINT STOCK COMPANY, VIETNAM ETC 483
11/28/2017 - 03/23/2018
ABBVIE INC, NORTH CHICAGO, IL ETC 483 05/18/2012 - 07/03/2018

FRESH EXPRESS, INC, HARRISBURG, PA ETC 483 03/28/2014 -
09/01/2016
GE OEC MEDICAL SYSTEMS INC, SALT LAKE CITY, UT ETC 483
01/08/2018 - 07/13/2018
MAGNUS INTERNATIONAL GROUP, PAINESVILLE, OH ETC 483 06/15/2016
- 04/18/2018
RECS RE TAMPER-EVIDENT/TAMPER-INDICATING PACKAGING FOR OTC
PACKAGING
Transcript of the Circulatory System Devices Panel Meeting
November 30, 2007
MIFEPRISTONE AERS
CHANGZHOU JINTAN QIANYAO RAW MATERIAL FACTORY, CHINA - EIR
01/02/2017 - 02/28/2017
Orphan Drug Application dated May 5 1993 and amendment dated
November 15 1993 Application Number 93-752
CADILA HEALTHCARE LIVA PHARMACEUTICALS, INDIA - 483
PROBIOTICS INTERNATIONAL LIMITED ETC 483 04/06/2016 -
05/25/2018
QUANTA SYSTEM SPA, SAMARATE, ITALY 10/10/2017 - 12/14/2017
SUN PHARMA, MOHALI,K INDIA - 483 08/15/2018 - 09/11/2018
NDA 018676
FOIA LOG PRILOSEC, NEXIUM 07/01/2018 - 07/31/2018
2018-3876
12 adverse event case numbers regarding insulin medication
errors
MICRO THERAPEUTIC RESEARCH LABS PVT LTD INDIA - EIR 01/01/2018
- 01/22/2018
DRUG APPROVAL DUODOTE CERTIFIED
K050094
BRENDA L WONG, MD, CINCINNATI, OH ETC 483 09/24/2013 -
07/05/2017
Supplement 8 to NDA 020717 PROVIGIL MEDICAL REVIEW, SUPERVISORY
REVIEW
FDA-1986-P-0052
SUMMARY BASIS OF APPROVAL NDA 207962
MEDROXYPROGESTERONE ACETATE ANDA 077334
SUMMARY BASIS OF APPROVAL ANDA 206685
SUBMISSION FROM JUUL LABS INC
MATERIALS FROM J WELLS, FRANCE IN RESPONSE TO FDA LETTER RE BO
STARTER KIT
AERS LINZESS, VIBERZI, XLIDRA ETC
Ever Approved List
K943997 K001647
CANAGLIFOZIN, DAPAGLIFOZIN, EMPAGLIFOZIN AERS
SUBMISSION FROM LIQUID FILLING SOLUTIONS, KING OF PRUSSIA, PA
IN RESPONSE TO FDA LETTER
RECS FROM INFLUENZA VACCINE MANUFACTURERS RE NEPHROTIC SYNDROME
ETC IN AERS 01/01/2009 - 09/08/2018
RESEARCH STRATEGY FOR PHASE 1 NIH AWARDED APPLICATION
K172866
NDA 015230
Approval letter for Lasix (furosemide)
SOUTHWEST BIO-LABS, LAS CRUCES, NM - 482, 483, EIR ETC
01/01/2016 - 09/10/2018
RECS BETWEEN CFSAN, CNPP, OC AND WESTON A PRICE FOUNDATION ETC
12/10/2003 - 12/23/2017
ADELLO BIOLOGICS, LLC, CHICAGO, IL - 483 07/15/2017 -
01/15/2018
2017-7180, 2018-4139, 2018-4144 etc
MIFEPREX INDIVIDUAL CASE REPORTS 5865734 5838355 5838355 ETC

BIOGEN, CAMBRIDGE, MA EIR, 483, CORR 2/9/16
MEDTRONIC 483 PREVIOUSLY RELEASED UNDER FOIA 08/07/2015 -
09/11/2018
Toxicology Review Memorandum to Dr. E. Petro regarding Food
Contact Notification (FCN) 001775
RFI INGREDIENTS, BROOMFIELD, CO - EIR, 483, LIST OF
INGREDIENTS, ETC 9/5/13 TO PRESENT
MERCK - GARDASIL-4, GARDASIL- 9 WARNINGS, DATA SUPPORTING
SAFETY IN HUMANS, SAFETY RVWS, ETC
PERRIGO CO TENNESSEE INC - BACITRACIN SBOA 4/1/90 TO 4/3/18
COPY OF THE RPT FOR EACH CLNCL TRIAL RELIED UPON BY THE FDA
WHEN APPROVING FLULAVAL FOR SIX MONTH OLD BABIES
VARICELLA - CLNCL TRIAL STUDY APRVL 1995
SHAH, ATUL, MD, PRINCE FREDERICK CENTER - EIR, 483, CORR 1/6/11
INDIVIDUAL RECS
INDIVIDUAL RECS
NEEDLE SPECIALTY PRODUCTS, BOYLE, MS - EIR 5/30/17 - 6/1/17
ROMAINE LETTUCE - SPLS 950791, 950792 LAB ANALYSIS, COLLECTIONS
RECSW, CHAIN OF CUSTODY RECS, ETC
ANTARES PHARMA INC - XYOSTED NDA
A & G PHARMACEUTICAL INC D16-00700 ARMED FORCES RADIOLOGY
RESEARCH INSITUTE D16-00610 BIOMEDICAL RESEARCH INSTITUTE D16-
00046, ETC 1/31/18 TO 4/30/18
ELECTROCONVULSIVE THERAPY DVC FOR CLASS II DRAFT GUIDANCE
12/29/15
NECROTIZING FASCIITIS - MED WATCH
CPT1801012-BY etc
BIOMAT USA, PITTSBURGH, PA - EIR, 483, CORR 2/15/17
CONSUMER COMPLAINT
BIOMAT USA, ANDERSON, IN - EIR, 483, CORR 2/1/18
BELCHER PHARMACEUTICALS, LARGO, FL - EIR, 483, CORR 5/13/16
MIFEGYNE CASE REPORTS 6027181 6186163 6186163 ETC
RECS RE FDA OPINION THAT A SYNTHETIC BOTANICAL REQUIRES A NEW
NDI NOTIFICATION
ACORDA THERAPEUTICS CHELSEA, MA - 483 03/01/2018 - 09/10/2018

PRESCRIPTION LABS INC, HOUSTON, TX 483 ETC
BIODIAGNOSTIC INTERNATIONAL, BEA, CA - EIR, 483, CORR 2/27/18

BECTON DICKINSON MEDICAL SYSTEMS, FRANKLIN, WI CARDINAL HEALTH
414, LLC, NEW ORLEANS, LA ETC 483
BIO-LABS, INC, LAS CRUCES, NM - EIR 08/08/2016 - 08/19/2016
WEINSTOCK, LEONARD, ST LOUIS, MO - EIR, 482, CORR 12/8/10
WARNING LETTERS FOR HUMAN DRUGS AUGUST 2018 08/01/2018 -
08/31/2018
NDA 18687 S-005 ETC
Correspondence between Interchem and FDA regarding KVK tech
and/or hydroxyzine HCl - CDER, PHILADELPHIA
MIFEPRISTONE REPORTS 4109101 4191043 4191043 ETC
APPROVAL RECS ONPATTRO NDA 210922 FIRST PARTY
AKORN, SOMERSET, NJ - 483 07/01/2018 - 09/10/2018
DUSTIN ROSS WARNING LETTER 02/01/2017 - 11/01/2017
Office of Orphan Products Development's Standard Operating
Procedures and Policies 420 (SOPP 420), concerning Orphan
Designation Applications
ANDA 074759
TAMIFLU APLASTIC ANEMIA AERS 7181285, 7398421, 7225824,
7223851, 6054984
CHINA HEALTH CARE DATEA
FOI summary for NADA 099-008
All documents responsive to FOIA requests
All documents responsive to FOIA requests related to Vivus
Corporation 01/01/2017 - 09/12/2018
BK180211
NDA 206488
DEN180044 Q172032
CORR, MEMO ETC RE COFFEE FRUIT, COFFEE CHERRY, COFFEE SKIN ETC
09/01/1998 - 09/11/2018
FOIA DAILY LOG 07/11/2018 - 09/12/2018
ZIMMER BIOMET - 483, EIR 01/01/2014 - 01/19/2018
ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD 483 07/02/2018 -
09/11/2018
DAF 95131 Mepron (Methionine source for ruminants) as filed by
Evonik
Any meeting minutes, meeting agendas, or decision logs created
between August 1 and September 1, 2018, by the FDA Nicotine
Steering Committee.
2018 FDA EMPLOYEE VIEWPOINT SURVEY
MEDMOXYPROGESTERONE ACETATE ANDA SBA, BIOEQUIV, LBLG
KLONOPIN
CORR BETWEEN FDA & TERUMO CORP
TAXOTERE - ISR10213862
JOHNSON & JOHNSON - COSMETIC TALC & TALCUM POWDER PRODUCTS RECS
FINASTERIDE - EFFICACY, AER
WRIGHT MEDICAL, ARLINGTON, TN - EIR, 483, WARNING LETTERS ETC
01/01/2017 - 01/22/2018
IND 78,823 - TOXICOLOGY INFORMATION
EVER APPROVED LIST OF DRUGS SINCE 1938
ANDA 210392 APRVL
BOSTON SCIENTIFIC - SPECTRA WAVEWRITER SPINAL CORD STIMULATOR
SYS P030017/S271
Information that was redacted out of the CMC reviews for NDA
21629/S8 and NDA 21081/S24
K172906
Invivoscribe Technologies, San Diego, CA Labpmm, San Diego, CA
483, EIR 01/01/2016 - 12/31/2018
ACREVUS AERS
DEN180042
DEN180044
ZIMMER BIOMET EIR, 483, WARNING LETTERS ETC 08/22/2017 -
01/22/2018
MEAD JOHNSON NUTRITION, EVANSVILLE, IN ABBOTT, STURGIS, MI -
INSPECTION RECS 01/01/2007 - 12/31/2015
MEAD JOHNSON NUTRITION, EVANSVILLE, IN ABBOTT, STURGIS, MI -
INSPECTION RECS 01/01/2007 - 12/31/2015
SIMMONS PET FOOD, INC, TOPEKA, KS - 482, 483, EIR 01/01/2017 -
09/12/2018
Grant Applications 1R13FD006468-01 (2018 NASDA Annual Meeting)

1R13FD006470-01 (2018 OHDSI Symposium) and 2U01FD005942-03
(Johns Hopkins Center of Excellence in Regulatory Science an
Innovation)
OMEGA & DELTA CO, INC CAROLINA, PR MYLAN, LLC, CAGUAS, PR -
483 01/26/2017 - 03/15/2018
K162010, K160992
SIMMONS PET FOOD, INC, PENNSAUKEN, NJ - 482, 483, EIR
01/01/2010 - 09/12/2018
YUNG SHIN PHARM INC CO LTD, TAIWAN - 483 07/02/2018 -
08/10/2018
SSED for Adatomed Silicone Oil Op5000 (manufactured by Bausch &
Lomb) PMA P910071
INTUITIVE SURGICAL IN UNAPPROVED PRODUCT ION 01/03/2017 -
01/19/2018
HHSF223201810001B (RFP FDA17SOL1179013)
SIMMONS PET FOOD DRY OPERATION, DECATUR, AR - 482, 483, EIR
09/06/2014 - 09/12/2018
FDA FOIA log for the time period August 1, 2018 to August 31,
2018, where information was requested concerning Prilosec
and/or Nexium
SIMMONS PET FOOD, INC, EMPORIA, KS - 482, 483, EIR 01/01/2014
- 09/12/2018
SSED for Silikon 1000 (manufactured by Alcon) PMA P950008
SMITHS MEDICAL ASD INC, VERNON HILLS, IL - EIR 06/01/2017 -
08/01/2017
PMA 130008
Tentative approval (TA) letter request of Actaviss ( ANDA
#208697,letter received 09/28/17) ) For Deferasirox tablets
(Generic of Jadenu 90, 180, and 360mg).
SIMMONS PET FOOD, INC, SILOAN SPRINGS, AR - 482, 483, EIR
11/17/09, 01/08/10,10/17/11, 02/27/14
Summary Basis of Approval for CLINDAMYCIN PHOSPHATE AND
TRETINOIN GEL, 1.2% 0.025% (ANDA# Applicant Holder: ACTAVIS
MID ATLANTIC
ANDA 207970
DEN180042 Q180780
The Most recent Package insert for Invega (paliperidone)
Extended-Release Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg (NDA
#021999/S-035)
Information that was redacted from the chemistry review for NDA
205747
Information that was redacted from the chemistry review for NDA
206538
SUMMARY BASIS OF APPROVAL FOR ORIGINAL ANDA 206685 SUMMARY
BASIS OF APPROVAL FOR ORIGINAL NDA 207962
Food Additive Petition 7A3987 for Sucralose
RECS RE DESIGNATION OF CAYSTON AS ORPHAN DRUG
2017-5594, 2014-1917, 2018-6858, ETC
ZOFRAN - ISRS 3328969, 5904089, 5904116, ETC
DR REDDY'S LAB LTD - LIPOSOMAL (DOXORUBICIN HCL) ANDA 208-657
BIOEQV
NURSE ASSIST, HALTOM CITY, TX - EIR, 483, CORR 10/12/2016 -
11/23/2016
ABBVIE, NORTH CHICAGO, IL - EIR, 483, WARNING LETTERS ETC
01/01/2017 - 01/22/2018
COHERUS BIOSCIENCES INC, TEVA PHARMACEUTICAL INDUSTRIES LTD,
CELLTRION HEALTHCARE CO, ETC - 483S, WARNING LTRS, CLOSE-OUT
LTRS 9/11/17 TO PRESENT
GLYPHOSATE TESTING QUESTIONS FDA/CDC
KBI BIOPHARMA INC, BOULDER, CO COHERUS BIOSCIENCES INC,
CAMARILLO, CA, REDWOOD CITY, CA - EIRS
VEROBLUE FARMS, USA, INC, WEBSTER CITY, IA - UNREDACTED
COMPLAINT, INVESGTIGATION RECS ETC 01/01/2017 - 09/30/2018
LIST OF 483S 01/01/2018 - 09/10/2018
Facility status (OAI, VAI, NAI) for Celltrion facility with
establishment number 3005241015, located in Incheon, South
Korea
JOHN DAVID CRUMPTON - INVESTIGATION RECS
NDA APPROVAL PACKAGES

RECS RE TENEX REMOVAL FROM MARKET
SALZBERG, BRUCE A, ATLANTA, GA - EIR, 483, CORR 11/17/2008 -
12/08/2008
DATA REFERENCED IN SPEECH ON E-CIGARETTES 01/01/2018 -
09/30/2018
CERTIFICATES OF FREE SALE CFSAN 01/01/2017 - 12/31/2017
CERTIFICATES OF FREE SALE CDRH 01/01/2017 - 12/31/2017
VALSARTAN INVESTIGATION, RECALL RECS 01/01/2014 - 09/12/2018
COMPASS-XT Trial final study results, including adverse event

results, for the Cypass glaucoma device, conducted by Alcon and
Transcend Medical. ClinicalTrials.gov Identifier: NCT02700984
The full inspection report related to the FDA's July 5, 2018
Risk Alert titled "FDA'S investigation into Guardian's
compounded triamcinolone-moxifloxacin drug product"
Modified spreadsheet for Certificates of a Pharmaceutical
Product
Correspondence between FDA and Corcept Therapeutics related to
adverse events for Corcept's Korlym drug
MEDWATCH RECS DESVENLAFAXINE LUPIN
LIST OF COLA NUT FACILITIES 09/12/2017 - 09/12/2018
GILEAD SCIENCES, FOSTER CITY, CA - EIR, 483, WARNING LETTERS
ETC 01/01/2017 - 01/22/2018
Orphan Drug Designation and Approval for lisocabtagene
maraleucel
ORTHOSOFT DBA ZIMMER, MONTREAL, QUEBEC ZIMMER BIOMET, WARSAW,
IN - INSPECTION RECS, CORR 01/25/2016 - 09/12/2018
FARMERS' RICE COOPERATIVE, SACRAMENTO, WEST SACRAMENTO, CA -
483 ETC 01/01/2010 - 09/12/2018
Complaint information status for FDA CC 154841
SEATECH INTERNATIONAL INC, BOLIVAR, COLOMBIA - EIR 08/03/2009
- 08/05/2009
INVESTIGATION RES B CEPACIA CONTAMINIATION OF DIOCTO LIQUID,
PHARMATECH LLC, DAVID, FL SAMPLE RECS 01/01/2016 - 12/31/2016
ANDA 209720, ANDA 061621, ANDA 062298 SBA

COMMUNICATIONS FROM NIRMAL MULYE, NOSTROM LABORATORIES, TO
SCOTT GOTTLIEB 01/01/2016 - 09/13/2018
OSUKA PHARMACEUTICAL CO - ABILIFY NDA 21-436 TARTER PACKS AS
PROMOTIONAL LBLG 11/02 TO 2006
N-MOLECULAR INC DBA SOFIE, HAVERHILL, MA TENDER CORPORATION,
LITTLETON, NH - 483 02/12/2018 - 06/07/2018
IND application Anavex Life Sciences
NDA 14-717
TEVA PHARMS - WARNING LTRS, INSPS, CRIMINAL INVESTIGATIONS, ETC
2009 TO 2012
RECS RELEASED UNDER FOIA SSED PMA 860004 ETC
513(g) request from Firefly Medical, Incorporated dated:
January 23, 2007, received: March 23, 2007, and response sent
May 10, 2007 with the 513(g) number of C070108
SKELETAL DYNAMICS LLC - IMPLANT NUMBER ALN #1-240 IMPLANT
NUMBER ALN-RST-1000 CMPLNTS, RECALLS
DKT 1982P-0316 ELECTROCONVULSICE THERAPY - MEMOS, NOTES,
STUDIES, ETC 1980 TO 1984
SOMATICS LLC - ECTOBRAIN CORR ELECTROCONVULSIVE DVCS 510K
CLEARANCE
ARTHREX ACL TIGHTROPE K112990 ARTHREX PCL TIGHTROPE K110123

ARTHREX TIGHTROPE SYNDESMOSIS REPAIR KIT K043248, ETC
AMCOL HEALTH AND BEAUTY SOLUTIONS INC - TRETINOIN 4% POLY-POREr
POLYMER DMF 23186
PROGRAF, XELJANZ - SBA
K131895
ELECTRO ACUSCOPE, TENS DVC, ETC - RECS, PICTURES
US SMOKELESS TOBACCO CO - SUBSTANTIAL EQUIVALENCE RPTS
SE0014494, SE0014495, SE0014496, ETC
JOHN MIDDLETON CO - EXEMPTION RPT EX0000244
SEAN DUKE TRAVEL RECORDS 06/06/2018
COMMUNICATIONS BETWEEN FCC AND APPLE
BOND PHARMACY, INC DBA ADVANCED INFUSION SOLUTIONS, RIDGELAND,
MS - EIR 09/01/2015 - 11/15/2017
RECS RE INSPECTION OF MANUFACTURING FACILITIES IN CHINA, INDIA
RE HUMAN DRUGS 01/01/2008 - 09/13/2018
NDA 016636
EDWARDS LIFESCIENCES REQUESTS TO PARTICIPATE IN THE ALTERNATE
SUMMARY REPORTING RE SAPIAN, SAPIENT XT, ETC
CHIC FOODS, THAILAND - EIR, 483 05/24/2016
K171909, K171334, K160987, ETC
NDA 201739
ANDA 090725
PAR STERILE PRODUCTS LLC, ROCHESTER, MI - EIR 11/01/2014 -
11/30/2014
PALYNZIQ AERS
A summary clinical information provided as part of Apple Inc's
application for clearance of their ECG technology for the Apple
Watch Series Four etc
K152684
K163446
Food Additive Petition for N,N-Bis(2-hydroxyethyl)alkyl(C12-
C18)amine
FDA Chemistry memos on N,N-Bis(2-hydroxyethyl)alkyl(C12-
C18)amine
FDA toxicology memos on N,N-Bis(2-hydroxyethyl)alkyl(C13-C15)
amine
2017-1246
K153655
BRAVO PACKING, CARNEYS POINT, NJ - 483, COMPLAINTS, EIR ETC
01/01/2015 - 12/31/2016
APPLE WATCH APPLICATIONS
XEOMIN EFFICACY SUPPLEMENT
EMAILS BETWEEN DEBORAH J MILLER, DAVID WEINSTEIN, BARBARA GOULD
ETC
PURE SOURCE LLC, DORAL, FL - 483 02/08/2018 - 03/01/2018
K083552
List of the publications that CTP used to substantiate a

specific statement in its 2018 report titled, Tobacco
Regulatory Science Research Program at FDAs Center for Tobacco
Products: Summary and Highlights
K140666
K172607
HEALTH ADVANCES USA INC - RPTS, RECALLS, CORR, ETC 1/15 TO
PRESENT
P110014
2017 RJ Reynolds/American Snuff Product Listing (June and

December) and any HPHC Reports/Ingredient Listing specifically
for the following products: Grizzly Premium Dark Select Long
Cut (Product Identification: RPT1383) and Grizzly Premium Dark
Winte
SUN PHARMA, MOHALI, INDIA - 483 09/01/2018 - 09/14/2018
SUMIKA CHEMICAL ANALYSIS SERVICE, LTD, JAPAN - 483 01/01/2017 -
09/14/2018
RECS RE IMPOSSIBLE FOODS, IMPOSSIBLE BURGER, HEME 09/01/2016 -
09/14/2018
RECS RE HMO, HUMAN MILK OLIGOSACCHARIDES FOR PERRIGO, NESTLE,
GERBER ETC 1/1/16-9/13/18
DERMAMED SOLUTIONS, LLC, LENNI, PA - INSPECTION RECS 05/01/2014
- 06/01/2014
All toxicology reports and FDA toxicology memos on N,N-Bis(2-
hydroxyethyl)alkyl(C12-C18)amine
K150949
Records regarding Recall F-2348-2015
Medtronic Strata II / Strata NSC Valves ADVERSE EVENTS
A copy of Threshold of Regulation (TOR) Exemption No. 2013-001,

including the submission documents, and all chemistry,
toxicology, and environmental review memoranda that were
developed by FDA in support of TOR 2013-001
Laboratory analytical method for tissue residues. Analytical
method number LIB# 4567
K152021 K102734
LIST OF INSPECTIONS, INSPECTION CITATIONS 09/15/2017 -
09/15/2018
CELLTRION INCHEON, KOREAN FMD 145 09/16/2017 - 09/16/2018
STRIDES INDIA, BANGALORE, INDIA - 483 08/15/2018 - 09/14/2018

AMBIEN, ZOLPIDEM, CYMBALTA, ETC - RECS, AERS, RECALLS, ETC
LIST OF DRUGS APPROVED SINCE 6/25/38
NSPIRE NETWORK LLC, DULUTH, GA STOCKBRIDGE, GA - REGISTRATION,
GMP CERTIFICATE OF ANALYSIS, 510K PREMARKET NOTIFICATION
CELLTRION INC, KOREA - 483, WARNING LETTER ETC
EMIALS BTWN FDA COMMISSIONER, ASSOCIATE COMMISSIONERS, AND
STAFF AND EMAIL ADDRESSES ENDING IN @APPLE.COM, @GOOGLE.COM,
@23ANDME.COM, @FB.COM
OXYCODONE - ISRS 11944220, 11947946, 11995701, ETC

NIACET CORP - CALCIUM ACETATE GRAS NOTIFICATION
CHINA RESOURCES SANJIU MEDICAL AND PHARMACEUTICAL CO LTD - EIRS

GLYCOPYRRONIUM BROMIDE - TOXICOLOGICAL DATA
OXYCODONE - ISRS 12045877, 12060990, 12465018, ETC

ARBOR PHARMA - AMPHETAMINE SULFATE TABS ANDA 200-166 SBA
AIG TECHNOLOGIES, DEERFIELD BEACH, FL - EIR, 483, CORR
09/29/2015 - 11/17/2015
RESPONSE FROM FDA TO LETTER FROM SEN CHUCK GRASSLEY RE DR
WILLIAM HALFORD 01/04/2018 - 01/23/2018
FDA FOIA LOG EXCEL 09/03/2018 - 09/17/2018
2018-6302
Medtronics StrataMR Adjustable Valves and Shunts AERS
ANDREW VON ESCHENBACK, LESTER CRAWFORD, FRANK TORTI, ETC
EMAILS, CORR RE OPIOID ETC
ENFORCEMENT REPORT RE MEDICAL DEVICE RECALLS 01/01/1990 -
01/23/2018
VALSARTAN - TEST RESULTS 06/01/2018 - 09/15/2018
2018-4818
SUN PHARMACEUTICAL, MOHALI, INDIA - 483 08/01/2018 - 09/16/2018
ANDA 090513
TEIKOKU SEIYAKU COMPANY LTD, JAPAN - 483 07/01/2018 -
07/31/2018
NDA 021912
K141865 K122149 K133382
K072862 K111609
Adverse events report about the use of VSL#3 medical food
14037591, 14078435, 14092410, etc
BREIDENBACH CHIROPRACTIC, LACROSS, WI - INSPECTIONS ETC
01/01/2014 - 01/01/2018
K173575
K171403
P980024 Supplement# - S008 APPROVAL LETTER
K182226 FIRST PARTY
K160520
Response from FDA to Sen. Edward J. Markeys August 17, 2018
letter that requested a response no later than September 5,
2018
MIMEDX GROUP INC, MARIETTA, GA - 483 ETC 01/01/2012 -
09/17/2018
K160026
LETTER FROM ANNA K AMBRAM TO SEN EDWARD MARKEY RE REMS, LETTER
FROM SEN EDWARD MARKEY
All Documents Regarding the 2013 Review of Reported Problems on
Essure Complaints
GENZYME, WALTHAM, MA - EIR 09/01/2011 - 09/01/2012
CTP Memorandum: SE Review: Evaluating carcinogenic HPHC
increases and assumption of linearity for low-dose
extrapolation, November 17, 2017
Research & Data Regarding Youth Use of E-cigarettes Referenced

in 09/12/2018 Press Release by Commissioner Gottlieb
EI PHARMACEUTICALS, KANNAPOLIS, NC 0 483, EIR OCT 2017
FOUNDATION CARE, EARTH CITY, MO - INSPECTIONS, INVESTIGATIONS
01/01/2015 - 12/31/2018
PMA approval letter in regards to Mentor MemoryGel P030053
The orphan drug application and orphan designation related

records for: Daratumumab for the treatment of multiple myeloma
ZEPATIER CASE REPORTS
Laser Product Reports (Form FDA 3632) submitted by Magic Leap,
Inc. ETC
Abbreviated Reports for several exemptions from substantial
equivalence
DEN180042 DEN180044
CPT1700192 CPT1700193
Number of domestic drug establishment inspectors employed by
the FDA each year for the years 2007 to 2018
CTP Memorandum Fractional factorial design and interchangeable
components in tobacco products, Sept. 29, 2016. Please see
attached for additional information.
MYLAN, ZHEJIANG HUAHAI - DOWNGRADE MEMOS
XOLAIR SBA BLA 103976
LIST OF INSPECTIONS DRUGS, DEVICES, IRB 01/01/2008 -
01/01/2018
2017-442, 2017-1000, 2017-2152, ETC
CARA WELCH - CV, HIRING PROCESS, PROMOTION PROCESS, ETC

Records, Correspondence Regarding SVR, Inc.s response to FDAs
904(b) request in 2018
CHAMPION PETFOODS USA - COMPLAINTS, REPORTS ETC
Case Number 14342785, relating to Januvia
RECS RE GRAS NOTIFICATION DOLOMITE
FDA Review documentation for Toradol NDA 019698
1) Communication with Sandoz regarding approved cosyntropin
label change 2) Communication with Mallinckrodt regarding
characterizing Acthar
All MDRs associated with the use of Medtronic's NavLock
Tracker etc
LETTER TO OTSUKA OUTLINING FDA REQUIREMENTS FOR A NEW CLINIAL
TRIAL FOR DRUG 01/09/2014 - 09/19/2018
Detailed reports related to the use of PD-1 inhibitors and PD-
L1 inhibitors and development of DKA.
K152258
GLENMARK PHARMA BADDI FACILITY FORM 483 INDIA 09/01/2018 -
09/17/2018
KERALINK SOUTHEAST, ORLANDO, FL - EIR UNREDACTED 08/07/2017 -
08/11/2017
HAUPT PHARMA WOLFRATSHAUSEN GMBH - EIR 01/01/2012 - 12/31/2017

ANDA suitability petition 01P-0108
AKORN INC, SOMERSET, NJ - 483 06/01/2018 - 09/18/2018
STEM CELL CENTERS OF EXCELLENCE, MIAMI - ADVERSE EVENT
K152276
483 issued to Acorda Therapeutics in Chelsea, Mass., for
preapproval inspection completed June 18, 2018
Food Contact Notification No. 1445
AMLODIPINE BESYLATE AERS, RECALLS, COMPLAINTS 11/13/2012 -
09/10/2018
ATL, MENOMONEE, WI - 483, EIR, RECALLS 02/15/2016 - 01/23/2018
Records as to what lab testing the FDA themselves has done
regarding glyphosate in vaccines.
INSPECTION OF BADDI FACILITY GLENMARK PHARMA FORM 483
09/01/2018 - 09/17/2018
STRIDES SHASUN, BENGALURU, INDIA - 483 08/01/2018 - 09/17/2018

LOVASTATIN AERS
PENTOBARBITAL POWDER, SOLUTION - IMPORT DATA 01/01/2015 -
12/31/2018
SYNERGY HEALTH AST, LLC, SAN DIEGO, CA - EIR 08/02/2018 -
08/02/2018
Case Number 14317616, relating to Belsomra (suvorexant).
CELLTRION, INCHEON - EIR 2017-2018
ESSURE FOIA REQUESTS
K180026
IRONMAG LABS - WARNING LTR 10/23/17
TROPHIKOS LLC, ATLANTA, GA - 483 12/01/2017 - 12/31/2017
Orphan Drug Designation and Approval for tisagenlecleucel-T

Copies of Form 483s issued by the Atlanta District Office from
August 1-31, 2018
Copies of Form 483s issued by the Baltimore District Office
from August 1-31, 2018
Copies of Form 483s issued by CBERs International Operations
Group from August 1-31, 2018
Copies of Form 483s issued by CDRHs International Operations
Copies of Form 483s issued by the Chicago District Office from
August 1-31, 2018
Copies of Form 483s issued by the Cincinnati District Office
Copies of Form 483s issued by the Dallas District Office from
August 1-31, 2018
HEALTH-CHEM DIAGNOSTICS, DIVISION OF P&L DEVELOPMENT, POMPANO
BEACH, FL - EIR, 483, CORR 01/02/2017 - 02/03/2017
2017-10724
Copies of Form 483s issued by the Denver District Office from
August 1-31, 2018
Copies of Form 483s issued by the Detroit District Office from
August 1-31, 2018
Copies of Form 483s issued by the Florida District Office from
August 1-31, 2018
Copies of Form 483s issued by the Kansas District Office from
August 1-31, 2018
Copies of Form 483s issued by the Los Angeles District Office
Case Number 14070036, relating to Janumet
Copies of Form 483s issued by the Minneapolis District Office
Copies of Form 483s issued by the New England District Office
Copies of Form 483s issued by the New Jersey District Office
Copies of Form 483s issued by the New Orleans District Office
RREQUEST PAPERS, PRESENTATIONS, EMAILS SENT AND RECEIVED BY
COREY HILMAS THAT MENTION KRATOM 1/11 TO 12/14
Copies of Form 483s issued by the New York District Office from
August 1-31, 2018
DERBY DENTAL CLEAR CUSTOM ALIGNER K173785 SMYLIO INVISIBLE
CLEAR ALIGNERS K173784
DOW CHEMICAL PEG 3350 DMF 1356
APRVD DRUG LIST SINCE 1938
PROSPECTIVE SINGLE BLIND RANDOMIZED PHASE III STUDY
WEST CHINA FRONTIER PHARMA TECH, SICHUAN, CHINA - 483
NATIONAL BEIJING CENTER FOR DRUG SAFETY EVALUATION & RESEARCH,
BEIJING, CHINA - 483
TDAP VACCINE BOOXTRIX - CLNCL TRIAL
BB-IND 9188 BB IND 8235
TAXOTERE (DOCETAXEL) NDA 201-525
KRATOM - PAPERS, PRESENTATIONS, EMAILS SENT AND RECEIVED BY
CARA WELCH 1/14 AND 12/17
VEROBLUE FARMS, WEBSTER CITY, IA - CMPLNT UNREDACTED 1/1/17 TO
9/30/18
CANAGLIFLOZIN DAPAGLIFLOZIN EMPAGLIFLOZIN - AERS
MEAD JOHNSON, ZEELAND, MI EVANSVILLE, IN - INSPECTION REPORTS
01/01/2001 - 12/01/2004
The toxicology and CMC sections from the candesartan cilexetil
tablets (ANDA 209119) Summary basis of approval
NDA 022038
SMART WORLD DBA STERI-TEK - EIR 8/15/2017 - 8/22/2017
VALSARTAN - AERS, CORR, RECALL RECS, ETC 7/18
Copies of Form 483s issued by CDERs International Operations
NDA 015197
483s issued by CDERs International Operations Group from
August 1-31, 2018
F & H STRATEGIES LLC - EMAILS SENT AND RECEIVED BY COREY HILMAS
1/11 TO 12/14
KEYTRUDA CASE REPORT
INOGEN, INC, RICHARDSON, TX GOLENA, CA - AERS, VIOLATIONS ETC
Range: 01/01/2014 - 09/01/2018
Establishment Inspection report and EIR summary and Downgrade
Memo for FDA's inspection of Mylan's Nashik facility that ended
March 25, 2015
Testing data used in the report titled "Summary Report: Raw
Milk cheese Aged 60 Days"
Copies of Form 483s issued by the Philadelphia District Office
STRIDES SHASUN LIMITED 483
Copies of Form 483s issued by the San Francisco District Office
Copies of Form 483s issued by the Seattle District Office from
August 1-31, 2018
Copies of Form 483s issued by the San Juan District Office from
August 1-31
TRANEXAMIC ACID - AERS, ANALYSIS, MEMOS, ETC
NATURAL PRODUCTS ASSOCIATION - EMAILS SENT AND RECEIVED BY
COREY HILMAS 1/11 TO 12/14
E COLI OUTBREAK FROM ROMAINE LETTUCE - INVESTIGATION RECS 2018

ANTARES PHARMA, INC, MINNEAPOLIS, MN ETC 483 12/21/2015 -
10/27/2017
DEPUY ATTUNE KNEE SYSTEM INVESTIGATION RECS 01/01/2010 -
09/18/2018
OFFICE OF LABORATORY ANIMAL WELFARE DIVISION OF COMPLIANCE
OVERSIGHT - CORR WITH ALABAMA STATE UNIV, AURBURN UNIV,
PRIMEDICA CORP, ETC 2/28/18-5/3/18
Periodic Reports related to STN PM0000010, PM00000ll ,
PM0000012, etc
NDA 017768
All releasable amendments that went along with the GRAS notice
for GRN 669
Documents related to the FDA's approval of High Fructose Corn
Syrup as GRAS
CENTRAL GLASS CO LTD, JAPAN - 483 06/01/2018 - 06/30/2018
CG AMERICA WARNING LETTER RECS
URSULA WING, NY, NY INVESTIGATION RECS 01/01/2018 - 12/31/2018

K180698
K163283
B AND R PRODUCTS INC, CUTLER BAY, FL - 483 AERS MONAT PRODUCTS
01/01/2017 - 09/19/2018
B AND R PRODUCTS, INC, CUTLER BAY, FL - 483 01/01/2018 -
09/19/2018 MONAT PRODUCTS AERS
K180618
K173675
K163645
K160431
K170658
NATURAL PRODUCTS ASSOCIATION - EMAILS SENT AND RECEIVED BY CARA
WELCH 1/14 TO 1/17
Documents and other policies that FDA developed as a result of
its Integrity of the Medical Device Review Process
K170102
JANSSEN ORTHO LLC, GURABO, PR - EIR 08/06/2018 - 08/28/2018

DRUG CLINICAL TRIAL RESULTS TABLES
All appendices submitted by the submitter and all
correspondences related to GRN 224 for trans resveratrol
K180634
MedWatch diphenhydramine
ERNIMICH INC - ENTRY #AGT00104126 BOND ENTRIES, NOTICE OF
ACTION, BILLS OF LADING, ETC
ANDA 206685
DEN180042 DEN180044
CHROMADEX - EMAILS SENT AND RECEIVED BY CARA WELCH 1/14 TO
12/17
DEN180042 DEN180044
K871157
K032922
CIPROFLOXACIN - RECS, LAWSUIT, SIDE EFFECTS, ETC
SHIGA TOXIN-PRODUCING E COLI ASSOCIATED WITH ROMAINE LETTUCE

3/18, 6/18 - LAB RESULTS, TRACEBACK AND DISTRIBUTION INFO, ETC
BRAVO PACKING INC - PERFORMANCE DOG FOOD TEST RESULTS, INSP
RPTS
OPADA ALSOHAILI MD - RECS
TEVA - ANDA 90-589 LBLG
TEVA PHARMS - PROPOFOL INVESTIGATIONS
TEVA PHARMS, IRVINE, CA - WARNING LTRS, WARNING LTR RESPS, RE-
INSPECTION RECS 2009 TO 2012
FCN 1129, FCD 113
REBECCA SECRITS SITE VISIT RECS 09/17/2018 - 09/19/2018
K152029
K880161
K163277
K811409
NDA 050299 NDA 019966 ETC
STRYKER MEDICAL DEVISION OF STRYKER CORPORATION, PORTAGE, MI
ETC 483 03/09/2015 - 03/01/2017
Adverse event reports regarding Propylthiouracil tablets for
its fatal cases of antineutrophil cytoplasmic antibody (ANCA)-
associated vasculitis
Adverse event reports regarding Methimazole tablets for cases

of Rhabdomyolysis in methimazole, identified by the Adverse
Event Reporting System within the January to March 2017 quarter
VENUS CONCEPT LTD - RESP TO FDA IT HAS COME TO OUR ATTENTIONS
LTR CPT1800784
CONGRESSIONAL JUSTIFICATION GUIDANCE RESOURCE FROM HHS TO FDA
Adverse event reports regarding certain fluoroquinolones for

its risk of hypoglycemia identified by the Adverse Event
Reporting System within the July-September 2017 quarter
Adverse event reports regarding posaconazole and itraconazole

for its risk of mineralocorticoid excess identified by the
Adverse Event reporting system within the January to March 2018
quarter
Adverse event reports regarding Dipeptidyl peptidase-4

inhibitors for its risk of rhabdomyolysis identified by the
Adverse Event Reporting System within the April to June 2017
quarter
ALMA LASERS - RESP TO FDA IT HAS COME TO OUR ATTENTION LTR
CPT1800705
NASHVILLE KITCHEN AND CANNERY, DICKSON, TN - 483 01/24/2018 -
02/01/2018
MEDTRONIC PUERTO RICO OPERATIONS CO, JUNCOS, PR - 483
04/23/2018 - 05/15/2018
CYNOSURE INC - RESP TO FDA IT HAS COME TO OUR ATTENTION LTR
CPT1800139
DEN140044 DEN160026 DEN170046
STRIDES, BANGALORE, INDIA - 483 08/01/2018 - 09/20/2018
K141865
K171534
HOSPIRA, KANSAS CITY, MO - 483 07/01/2018 - 09/20/2018
ANDA 074278
SPINAL CORD STIMULATORS AERS ETC
K072211
NDA 018342
NDA 20297
Electronic version of the annual FDA orange book, from year
2011 to year 2016, in total 6 pdf documents
ANDA 091161 SUMMARY OF BIOEQUIVALENCE STUDIES
INMIODE LTD - RESP TO FDA IT HAS COME TO OUR ATTENTION LTR
CPT1800704 7/24/18
RESP TO FDA IT HAS COME TO OUR ATTENTION LTR CPT1800792 7/26/18

SAMPLE RECS
THERMIGEN INC - RESP TO FDA IT HAS COME TO OUR ATTENTION LTR
CPT1800703 7/24/18
FOCAL ELECTRICALLY ADMINISTERED SEIZURE THERAPY USING
ELECTROCONVULSIVE THERAPY DVCS
LEADCARE BLOOD LEAD TESTING SYS K971640
K173090
CORDEN PHARMA LATINA, SPA EIR 04/01/2017 - 04/30/2017
Exemption requests from Intuitive Surgical or its agents, the
FDA respons(es) and a spreadsheet(s) containing the quarterly
reports filed since 1-1-2014
CORR, CALENDARS, RECS BETWEEN FDA DIGITAL HEALTH SOFTWARE PRE-
CERTIFICATION PROGRAM AND APPLY SINCE 1/1/17
PFIZER, MCPHERSON, KS 483 08/01/2018 - 08/31/2018
1. FDA Health Hazard Evaluation (HHE) for Acinetobacter
baumannii 2. FDA Health Hazard Evaluation for microbial
contamination of oral products
IMPAC Medical Systems Inc. 13723 Riverport Dr. Ste 100 Maryland
Heights, MO EIR 2/6/2017 - 2/10/2017
ENFORCEMENT REPORT 01/01/2006 - 12/31/2017
PHARMACEUTICAL INDUSTRY DATABASE 10/01/1999 - 09/01/2018
ARCO PET FOODS INC, BINGHAMTON, NY, HI-TECH PHARMACAL,
AMITYVILLE, NY 483 10/09/2013 - 02/24/2016
HOSPIRA INC, MCPHERSON, KS - 483 07/23/2018 - 08/08/2018
SEPTALIS PHARMACEUTICALS LLC, HAUPPAUGE, NY EIR 01/01/2018 -
09/20/2018
Exemption requests from Edwards Life Sciences or its agents,

the FDA respons(es) and a spreadsheet(s) containing the
quarterly reports filed since 1-1-2014 re: the Edwards Sapien 3
transcatheter heart valve
List of all research awards (Grants & Contracts) made from the
FDA to Duke University Department of Surgery Principal
Investigators from the year 1938 to current
K131855
Investigational Device Exemption (IDE) applications submitted

by Sandeep Bagla,MD and Ari Isaacson, MD for the use of
Embozene Microspheres in geniculate artery embolization
NDA 008107
K181465
HHSF223201510001B
AGIOS PHARMACEUTICALS, CAMBRIDGE, MA - EIR 01/01/2018 -
04/30/2018
GLAXOSMITHKLINE, DARTFORD, ENGLAND - 483, EIR 01/01/2005 -
12/31/2008
ASANUMA CORPORATION, JAPAN - 483 06/01/2018 - 06/30/2018
PHARMATORY OY, FINLAND - 483 SUMMER 2018
EVER APPROVED DRUG LIST
K170568
DEN180042 DEN180044
CV of inspector: Michael Charles
INDIVIDUAL RECS
Any safety or other review or analysis related to the April 7,

2011 FDA Drug Safety Communication regarding over-the-counter
benzocaine gels and liquids, including any communications or
reports reviewed in preparation of the April 7, 2011 Drug
Safety C
RFQ-FDA-2017-1180075
Gardasil adverse case reports
NEKTAR THERAPEUTICS - NKTR-181 IND PACKAGE
CLOVER PHARMACEUTICALS CORP - AMICAR NDA 15-230/S002 SBA, MOR,
RVWS, ETC
ADRIAMYCIN (DOXORUBICIN) - AERS
KORLYM - RECS
SOMATULINE DEPOT - RECS
UNIV OF CALIFORNIA AT DAVIS, VETERINARY LABORATORY
INVESTIGATION AND RESPONSE NETWORK - CONNECTION BTWN DIET AND
CASE OF CANINE HEART DISEASE
INFORMATION AS TO WHETHER FDA PURCHASED ADVERTISING CONCERNING
DIETARY SUPPLEMENTS ON THE GOOGLE AD NETWORK
INTEGRATED MEDICAL SYSTEMS INTERNATIONAL INC, HILLSBOROUGH, NJ
- EIR 2/25/16
FAERS DATA BEFORE 2004
K172398
K050702
K101133
K962928
INDIVIDUAL RECS
Docetaxel 3328969 5904089 5904116 ETC
K894625
Summary reports of adverse drug experiences for the animal
drugs Bravecto, Credelio, Nexguard, and Simparica
US ONCOLOGY, INC IRB ETC, HOUSTON, TX ETC INSPECTION RECS
01/01/1996 - 12/31/2017
C.O. Truxton, Inc RECS
FDA's October 22, 2010 denial letter sent to Imaging3 .Inc and
concluding to the no substantial equivalence of the Dominion
Scanner to the predicate device
ADDITION TECHNOLOGY, INC, LOMBARD, IL - EIR 09/13/2017 -
11/13/2017
CHELSEA FOOD SERVICES, NEWARK, NJ ETC - 483, EIR 01/01/2016 -
09/21/2018
List of (1) all manufacturers and importers of tobacco products

for which a user fee was received during the third quarter of
fiscal year 2018, and (2) all of the manufacturers and
importers of tobacco products for which a user fee was assessed
during
GRAS Notice No. 669
All warning letters and civil money penalties issued to
retailers for selling JUUL and other e-cigarettes to minors
between April 1, 2018 through September 19, 2018
UNREDACTED ADVERSE EVENTS
EXCELLA, NUREMBURG, GERMANY - 483 08/01/2018 - 08/31/2018
KITE PHARMA, EL SEGUNDO, CA - WARNING LETTER
DEN170088
GEN1800254
DEN180042
LifeSite Hemodialysis Access System/Cannula Exchange, Model
LHAS14120 & LHCEK0000 510K
ENERGY DRINKS AERS
2018-6810
FDA's Medical/Clinical NME review documents NDA 018612, NDA
018776, NDA 050554, ETC
PLI NOVARTIS PHARMACEUTICALS CORPORATION, MORRIS PLAINS, NJ -
WARNING LETTER
K111442
COMPLAINT RECS
Voluntary Cosmetic Registration Program (VCRP) records
BACKGROUND CHECK
P870069
DEN180044
ZIMMER BIOMET INC, WARSAW, IN - EIR 01/01/2016 - 01/22/2018
Johnson & Johnson Consumer Inc. Lititz, PA 17543 Establishment
Inspection Report 7/6-7/17
2008-3514, 2005-13211
HOMEOPET PRODUCTS - WARNING LTRS, RESP 1994 TO 1999
PFIZER, KANSAS CITY, MO SYNTHON LABS, RIDER SYNTHON LIMITADA,
SAN LORENZO, CHILE - 483, WARNING, EIR
AMPRO CMPLNT
CONTRACT BETWEEN FDA & ADVANCED BIOSCIENCE RESOURCES INC THAT
WAS CANCELLED ON 9/24/18 PER HHS ANNOUNCEMENT
LUCID VIVASCOPE K080788
MEDICAL DEVICE LISTING FILES 01/01/2008 - 09/20/2018
UNREDACTED FILING
FOOD FACILITY REGISTRATION
K170409
CLOSED FOIA LOG 08/13/2018 - 09/27/2018
CLOVER PHARMACEUTICALS CORP - AMICAR (AMINOCAPROIC ACID) NDA
15-230 SBA, MOR, RVWS, ETC
AMGEN - MVASI BLA #761028 APRVL RECS
EIR, CORR FOR INSPECTIONS 01/26/1982 - 09/18/2018
BOEHRINGER INGELHEIM, FREMONT, CA EXCELLA, NUREMBERG, GERMANY

PATHEON, GREENVILLE, NC ETC 483, EIR 01/01/2018 - 09/30/2018
All available informaton on 132 deaths reported from Mirena IUD
in FAERS database and all available information on 11 Paragard
deaths reported in FAERS database
A copy of all complaints submitted to MedWatch, any Consumer

Complaint Coordinator and/or the Office of Prescription Drug
Promotion concerning IUDs (intrauterine devices including but
not limited to Mirena and ParaGard) made between January 20,
2008 a
NDC CODES
Form 3147 - Application for a Variance From 21 CFR 1040.11(c)
for a Laser Light Show, Display, or Device
SUN PHARMA, HALOL, INDIA - RESPONSE TO 483 01/01/2018 -
09/24/2018
TERUMO CORPORATION, JAPAN - 483 01/01/2017 - 12/01/2017
TRIMEDYNE INC, IRVINE, CA - EIR 08/23/2016 - 08/25/2016
NURSE ASSIST, INC, HALTOM, TX - 483, ROOT CAUSE ANALYSIS
09/01/2016 - 09/22/2018
Recalls F-1761-2018 (Taco Bell Salso Con Queso Mild), F-1779-
2018 (Ritz Bits Cheese Pouches), and F-0881-2018 (Key Lime Pie
Handcrafted All-Natural Pop).
THALIDOMIDE RECS
RECS RE STORES VISITED BY REBECCA SECRIST 09/17/2018 -
09/17/2018
Travatan Z .004% eye drops AERS
SUN PHARMA, HALOL, INDIA RESPONSE TO 483 01/01/2018 -
09/24/2018
2017-5904, 2017-6041, 2017-6662, ETC
05/01/2018 - 09/24/2018 Any notifications for closure of

collection centers by Blood Assurance in the cities of
Kingsport, TN, Johnson City, TN, Brisol, VA, or Abingdon, VA.
Listing of all initiated or official management directed
reassignments within FDA Office of Human Resources
Docetaxel 7346937 7347078 7355349 ETC
K962166
BLA125057, Supplement 393
Course registration rosters for all diversity and inclusion in
person training courses held by the FDA Office of Equal
Employment Opportunity
FDA Office of Operations introduction video as posted on the
FDA Office of Operations intranet page
FDA FORM 3500 AND FDA FORM 3500B TRINESSA
All detail vacancy announcements only announced within FDA
University, including opening date of vacancy and date of
selection notification to selectee(s)
Listing of all employees officially reporting/assigned to FDA
University Human Capital Solutions Division
Listing of all employees officially reporting to the Workforce
Relations Division of Office of Human Resources
ZOFRAN CASE 6414433
GLENMARK, BADDI, INDIA 483 09/17/2018 - 09/24/2018
FDA Office of Human Resources department or division (and

corresponding employees) assigned to assist managers with
performance management, including guidance on performance
discussions, guidance on mid year and end of year
accomplishments, and PMAP ap
SAMPLE RESULTS
EMAILS STEVE'S REAL FOODS 01/01/2018 - 04/01/2018
All grades, series, and titles of all employees assigned to
FDA University including the Human Capital Solutions division
CAERS - 2018-CFS-007648, 2018-CFS-007649, 2018-CFS-007651, ETC

XCELIENCE LLC, TAMPA, FL - EIR 06/01/2017 - 07/31/2017
14709631 14554626 15349493 ETC
PPD, HIGHLAND HEIGHTS, KY - EIR, 483, WARNING LETTER 01/01/2013
- 09/25/2018
WAYNE STATE UNIVERSITY, DETROIT, MI - EIR, 483, WARNING LETTER
01/01/2013 - 09/25/2018
CARE-TECH LABORATORIES, SAINT LOUIS, MO - 483, EIR, CORR
10/25/16
CBI LABORATORIES, FORT WORTH, TX - 483, EIR, CORR 12/5/17
CHARLES RIVER LABORATORIES, WILMINGTON, MA - 483, EIR, CORR
6/21/17
K162315 K151651 K172032
CHECKPOINT SURGICAL, CLEVELAND, OH - 483, EIR, CORR 3/15/18
K101185
BIOTE MEDICAL, IRVING, TX - 483, EIR, CORR 11/4/16
BOSTON SCIENTIFIC CORPORATION, LOS GATOS, CA - 483, EIR, CORR
8/17/17
BRAINTREE LABORATORIES, HOLBROOK, MA - 483, EIR, CORR 2/28/18

GP PHARM, SPAIN EIR, 483 01/01/2010 - 09/25/2018
CAREFUSION 303, SAN DIEGO, CA 483, EIR, CORR 9/29/14
TSI NO 1306 SUMMARY REVIEW, MEMO
Department of Gastroenterology and Inborn Error Products
(DGIEP) Memorandum, Analyses, or Reviews conducted pursuant to
TSI No. 1306
BRISTOL MYERS SQUIBB MANUFACTURING COMPANY, HUMACAO, PR - 483,
EIR, CORR 11/18/16
CAERS-ASCII-2004-2017Q3
SEAN DUKE EMAILS RE KOHL HARRINGTON, PET FOOLED, PET FOOD ETC
06/01/2018 - 09/25/2018
IND and associated documents for RO-1138452 CAS # 221529-
58-4 4,5-dihydro-N-4-4-(1-methylethoxy)phenylmethylphenyl-1H-
imadazol-2-amine
JULI PUTNAM EMAIL RE KOHL HARRINGTON 01.01.2018-09.25.2018
I'm requesting FDA records for or relating to HPP being a kill
step for pet food and/or raw pet food
CHONGQING SOUTHWEST NO 2 PHARMACEUTICAL FACTORY CO, CHINA -
482, 483 09/01/2014 - 09/25/2018

SUZUKEN CO LTD, NAGOYA, AICHI, JAPAN - EIR 6/25-28/18
AKORN PHARMACEUTICALS INC, DECATUR, IL RESPONSE TO 483
01/01/2018 - 09/25/2018
FDA employees who sent e-mails from the AskCVM@fda.hhs.gov on
the date of 08.24.18
DR STEVEN SOLOMON, PET FOOD JOINT CONFERENCE - PENTOBARBITOL IN
PET FOOD TEST RESULTS, EMAILS, RECS, ETC
K170291
SARAH PEDDICORD EMAILS RE KOHL HARRINGTON, PET FOOLED
01/01/2018 - 09/25/2018
EMAIL CORR BETWEEN FDA AND SCOTT ZIEHR 01/01/2018 - 09/25/2018

EMAIL CORR BETWEEN FDA AND JANICE RIZZI, TRACEY HATCH
01/01/2018 - 09/25/2018
ORGANOGENESIS INC, VESTAVIA HILLS, AL ETC 483 01/01/2018 -
09/25/2018
RECS RE KOHL HARRINGTON ETC 09/21/2018 - 09/25/2018
CDC INVESTIGATIONS OF NONTUBERCULOUS MYOBACTERIAL INFECTIONS
ASSOCIATED WITH CARDIOPULMONARY BYPASS, CARDIAC SURGERY OR
HEATER-COOLER DVCS
DAN MCCHESNEY EMAIL RE KOHL HARRINGTON, PET FOOLED 01/01/2018 -
09/25/2018
EMAIL BETWEEN FDA AND MICHAEL VOGEL, DAVID VOGEL 01/01/2017 -
06/01/2018
POLARITYTE INC, SALT LAKE CITY, UT - INSPECTION RECS 01/01/2016
- 09/25/2018
CORR POLARITYTE RE HUMAN TISSUE COMPLIANCE WITH SECTION 361,
351
K033916
Line list request concerning Salmonella Adelaide Illnesses
linked to cut melon
NDA N021588
SIMILASAN CORR FROM CDER 11/30/05
K181368 K172944 K172731 CLINICAL TRIALS RECS
K021317
INDIVIDUAL RECS
JOHNSON AND JOHNSON BREAT IMPLANTS ASR 01/01/2008 - 01/24/2018

DAIWA PHARMACEUTICAL, JAPAN - 483 03/01/2017 - 12/25/2017
CAPSUGEL LICAPS, GREENWOOD, SC - EIR, 483 01/02/2014 -
01/24/2018
RESPONSE TO 483 FASCIABLASTER TO DALLAS DISTRICT 1/01/2017 -
01/24/2018
ALLERGAN ASR FOR PRODUCT CODES FTR, FWM, LCJ01/01/2001 -
01/24/2018
K160371
SCOTTS MIRACLE-GRO CO - WILD BIRD SEED PRODUCTS RECALL RECS
2008
SCOTTS MIRACLE-GRO CO - WILD BIRD FOOD PRODUCTS TESTING OR
INVESTIGATIONS RELATING TO LEVELS OF PESTICIDES, INSECTICIDES
OR CHEMICALS
EMAILS BETWEEN MICHAEL TAYLOR AND ALEX MALASPINA 07/07/2009 -
06/01/2016
K162905
K915859
LIST OF DRUGS DESIGNATED AS ORPHAN DRUGS SEPTEMBER, OCTOBER
2001
SPREADSHEET OF IMPORT REFUSALS
RADIUS HEALTH, WALTHAM, MA - EIR 10/31/2016 - 11/02/2017
K113201
RECS RE WEN HAIRCARE
SELENOMETHIONINE FAR, GRAS, ETC 01/01/1998 - 01/25/2018
INCLISIRAN ORPHAN PRODUCT RECS 01/01/2015 - 01/25/2018
RECS RE HOSPITAL BED MATTRESS COVERS THAT HAVE WORK OUT OR
DAMAGED ETC 01/01/2011 - 01/01/2018
CHILDRENS' VACCINATIONS HEP B, DTAB, ETC INSERTS
SUNOVION PHARMACEUTICALS, MARLBOROUGH, MA - EIR 04/23/2013 -
04/23/2014
K150350
FABBRICA ITALIANA SINTETECI SPA, ITALY - EIR 02/01/2017 -
02/20/2017
ANALYTICAL TEST METHOD, DETERMINATION OF EMAMECTIN BENZOATE
NDA 204042/S-026
NDA 208051 UNREDACTED
FRESENIUS KABI ONCOLOGY INDIA, 483, EIR, RESPONSES
ANDA 090430
CASES REFERRED FROM FDA TO FTC RE ANTI-COMPETITIVE BEHAVIOR BY
PHARMACEUTICAL COMPANIES 01/01/2013 - 01/23/2018
NDA 017469
MINUTES RE PRE-IND MEETING PIXARBIO CORPORATION, FRANCIS M

REYNOLDS, ORPHAN PRODUCTS APPLICATIONS 08/01/2015 - 01/01/2017
NDA 017011
PRESCRIBING RECS PARAGON FORTE DSC
INVOKANA, INVOKAMET AERS, COMMUNICATIONS, DATA
P140003/S005
NDA 022445
ANDA 207486
ANDA 207934
INDIVIDUAL RECS
NEW STRATEGIC PLAN TO IMPROVE RECALL MANAGEMENT ETC 01/01/2016
- 01/24/2018
FDA INTERACTIONS WITH TREMEAU PHARMACEUTICALS RE ROFECOXIB
2017-9381
CARPENTIER, EDWARDS LIFESCIENCES ASR 01/01/2000 - 01/24/2018

NASAL NOLOXONE COMPLAINTS ETC 01/24/2015 - 01/24/2018
NDA 022074 SUPPLEMENTS
K133901 K123720
CDER ANDA SPREADSHEET
K053110, CLIA WAIVERS
WUXI BIOLOGICS, CHINA - 483, EIR, WARNING LETTERS 01/01/2017 -
01/25/2018
CDER NDA SPREADSHEET UPDATE
NDA 017407 NDA 018891
INVOKANA, INVOKAMET, INVOKAMET XR COMMUNICATIONS RE MEDICATION
GUIDE 01/01/2008 - 01/25/2018
CORCEPT THERAPEUTICS KORLYM COMMUNICATIONS RE CUSHING'S
SYNDROME 01/01/2016 - 01/25/2018
ANDA 200166
OXYCONTIN LABEL RECS
K172677, 152189, K122172, ETC
CARVEDIDOL PHOSPHATE EXTENDED RELEASE CAPSULES RECS RE DECISION
180 DAY EXCLUSIVITY ANDA 090132
UNCLAIMED CHECKS TO FOI
2012-709, 2012-684, 2012-610
RESORBABLE CALCIUM SALT BONE VOID FILLER DVC - GUIDANCE
ACTAVIS MID ATLANTIC LLC - CLOBETASOL PROPIONATE, HI TECH

PHARMACAL CO INC - CLOBETASOL PROPIONATE, PERRIGO ISRAEL
PHARMACEUTICALS LTD - CLOBETASOL PROPIONATE - CHEMISTY RVW,
APRVL, SBA, LBLG
LUPIN LTD - BROMFENAC OPHTHALMIC SOLUTION ANDA 06-027 - DOCS

FDA-2017-N-0763
CORR BETWEEN MIMEDX GROUP INC & FDA 1/12 TO 1/15/18
VARUBI (ROLAPITANT) INJECTABLE EMULSION NDA 08-399 - AER
NDA 57-018
SAMPLES OF COUNTERFEIT CIGARETTES
MDR EMG MACHINES
CLIA WAIVER FOR K021317
ABBOTT VASCULAR MITRACLIP DELIVERY SYS P100009 - CIRCULATORY
SYSTEM DEVICES PANEL MTG 3/20/13 SLIDES
FDA ANALYSIS AND DECISION THAT SUN PHARMA DID NOT FORFEIR 180-
DAY EXCLUSIVITY FOR ANDA 90-132
K150646
VENCLEXTA MEDWATCH REPORTS
DMF 27975
NDA 018651
GEMINI PHARMACEUTICALS INC, COMMACK, NY - EIR MOST RECENT
P14003
K132646
D Petition filed by Panera (a/k/a Panera Bread) requesting that
the regulatory and commercially permissible meaning of "eggs"
be updated
SE0013799 - 808
K132646
K160501
ISR NORGESTIMATE, DESOGESTREL, GESTIDENE ETC
WILLIAM DEMANT, OSSUR, MEXICO - EIR, 483, ETC 01/01/2017 -
01/26/2018
POSITION DESCRIPTIONS ESSD, ORG CHART, VACANCY ANNOUNCEMENTS
12/01/2017 - 01/19/2018
BASF CORPORATION, GEISMAR, LA- EIR 07/14/2016 - 07/14/2016
MEETING MINUTES LOS-DO MED-PHARMEX INC 07/26/2017 - 07/26/2017

FDA Import Alert Petition Case #534446 Recs
RECS RE IMPRIMIS WARNING LETTER ETC 01/01/2015 - 01/26/2018
MED-PHARMEX, INC, POMONA, CA - EIR 01/17/2017 - 02/01/2017
CSBIO COMPANY, MENLO PARK, CA - EIR 11/15/2015 - 12/07/2015
TRIFEXIS AERS
ANDA-200888-SUPPL-1, ANDA-091367-ORIG-1-AMEND-17, ANDA-091226-
SUPPL-6 ETC
HEMCARE OF OREGON INC, WILSONVILLE, OR - EIRS, 483S, WARNING

LTRS, ETC LAST 2 YRS EMERITA (TRANSITIONS FOR HEALTH),
PORTLAND, OR - EIRS, 483S, WARNING LTRS, ETC LAST 4 YRS
PFIZER, MCPHERSON, KS - 483 09/30/2017 - 12/31/2017
KOREA TOBACCO AND GINSENG CORR, COMMUNICATIONS RE THIS,
CARNIVAL, TIMELESS TIME
K153638
LONZ WINERY, SANDUSKY, OH CREATIVE REFRESHMENT INC, TOLEDO, OH
- EIR, PHOTOS 10/02/2017 - 01/26/2018
K083111
K171658
HAMPTON CREEK INC - CELLULAR AGRICULTURE MTG MINS, RPTS, NOTES,
ETC 12/11/17
DEN 150037
K170209
PMA 95022, SUPPLEMENTS
K170551
K163415
HERRINGTON FARMS - RPTS, MEMOS, PHOTOGRAPHS RELATING TO WARNING
LTR NYK 2015-41
CPT1600902
K151070
ST JUDE MEDICAL - DURATA LEADS P950022 RPTS, CMPLNTS, CORR, ETC

JAMIESON - FORMS FDA 3500, 3500A, 3500B
DOCUSATE SODIUM - FOREIGN MFRS
COSMEGEN (DATINOMYCIN INJ) NDA 50-682 - SAFETY AND
EFFECTIVENESS DATA, SBA, RVWS
ELECTRONIC CIGARETTES, NICOTINE - RECS
FITBIT INC - HEART RATE FUNCTION OF FITBIT BRAND WEARABLE
FITNESS TRACKERS GUIDANCE, RECS
ANIMAL WELFARE COUNCIL MEMBER LIST, RESUMES, MISSING STATEMENT
01/01/2017 - 01/28/2018
SCOTT GOTTLIEB APPOINTMENT CALENDAR 01/20/2018 - 01/01/2018
SCOTT GOTTLIEB CALENDAR 05/09/2017 - 01/26/2018
INFLUENZA VACCINE - VAERS 1/10 TO PRESENT
OXYCONTIN USAGE CHILDREN 11 TO 17 FROM 2014 TO 2016
CELLTRION, KOREA - 483, WARNING LETTERS, CORR ETC
INDIVIDUAL RECS
NDA 16807
NDA 10379
HAW-DI-I Foods Co., Ltd. and Pin Pao Enterprise Co., Ltd. -
483 01/30/2018 - 02/12/2018
BAXTER HEALTHCARE CORPORATION, OPELIKA, AL - EIR 12/16/2015 -
12/17/2015
NDA 017453
Acyclovir Ointment APPROVAL RECS
SPS MEDICAL, RUSH, NY - EIR 12/31/2015 - 12/31/2017

FAP 7M4768
CIPRO, AVELOX, LEVAQUIN - WARNING LABEL
EXPAREL AERS 12515284 11927153 11926308 ETC
UPS-5342551-9 Line 261/1 Analytical package for sample
1029012
ROCHE COAGUECHECK, PROTIME MICROCOAGULATION APPROVAL, RECALLS

IV VARUBI MEDWATCH RECS 12/01/2017 - 01/29/2018
INDOCO REMEDIES LTD, GOA, INDIA - 483 01/15/2018 - 01/29/2018

FLUMAZENIL AERS 13098767 13098627
NDA 125166
ANDA 208594
ANDA 202337
NDA 003-402 NDA 204-485 LABELING, INSERT
EXONDYS 51, SPINRAZA - AER
ANDA 076369
Ralston Purina Cat Care Center, 1968. Digestibility and cat
maintenance ration (Unpublished studies). Submitted to WHO by
the United States Food and Drug Administration
Cigar SE Reports and question letters
HIGH ROAD CRAFT ICE CREAM INC, MARIETTA, GA NESTLE USA INC,
CLEVELAND, OH CLUB CHEF LLC, COVINGTON, KY, ETC - 483S 2017
SLAMON, DENNIS J, MD, LOS ANGELES, CA RICHARD S FINN, MD, LOS

ANGELES, CA ETC - INSPECTION RECS 01/01/2012 - 12/31/2016
ANDA 074646 ANDA 070733
CPT1701018
SE0002732, SE0002733, SE0002734, ETC
RICH PRODUCTS CORP, BROWNSVILLE, TX - 483 01/02/2014 -
12/30/2017
RECOMBINANT HUMAN FIBROBLAST GROWTH FACTOR IND 100267 - CORR,
INFORMATION REQUESTS
DIETARY SUPPLEMENTS 1/10 TO 11/1/17
CELLTRION INC - EIR 06/02/2017 - 01/30/2018
VOGA, MICROVISION, MOVIPHONE - VOGA V CELL PHONE WITH BUILT-IN
LASER PROJECTOR ISSUANCE OF AN ACCESSION NUMBER
Original FOI summary for NADA 103-037
MOHAMED EL-SHAHAWY, MD, LOS ANGELES, CA - EIR 02/16/2016 -
02/25/2016
GERALD HO, MD ADVANCED MEDICAL RESEARCH, LA PALMA, CA - 483
01/03/2018 - 01/30/2018
CONAIR CORPORATION, STAMFORD, CT - EIR 02/01/2015 - 02/28/2015

PANTOPAQUE RECS
HHSF223200950015I
HHSF223201310017I
2017-10302
DOMESTIC & FOREIGN INSP 9/19 TO 12/131/17
Tiamulin Official Residue Methods in Swine (Denagard NADA 139-
472)
K143372
MEDICAL DEVICE PATIENT LABELING WARNING EV3 INC/COVIDIEN
TURBOHAWK LX-M CATHETER
K162572
PM0000011 PM0000017 CTP REVIEW
GROCERY MANUFACTURERS ASSOCIATION - FOOD ADDITIVE PETITION
(FAP) 5A4811 USES OF PARTIALLY HYDROGENATED VEGETABLE OILS IN
SELECT FOODS
Annual FOIA Report for 2017 - Chief FOIA Officer Reports for
2016 and 2017
FOIA LOG 06/01/2015 - 01/31/2018

AMNEAL ANDA 208-077 - APRVL LTR, BIOEQV RVW
WARNING LETTERS TO PHYSICIANS 01/01/2012 - 12/31/2017
SONOTHERM 1000 ULTRASOUND HYPERTHERMIA SYS - PMA P8806
REP FRENCH HILL - CONGRESSIONAL CORR 1/1/15 TO 1/25/18
INDIVIDUAL RECS
BENDEKA - EXCLUSIVITY RECS
OCREVUS, TECFIDERA, TYSABRI, ETC AERS
DAEWOONG PHARMACEUTICALS, KOREA - EIR, CORR 01/01/2018 -
01/30/2018
CHIROGATE INTERNATIONAL, INC, TAIWAN - EIR 05/16/2014 -
05/23/2014
NEULAND LABORATORIES LIMITED, INDIA - EIR 04/03/2017 -
04/07/2017
WUXI BIOLOGICS, CHINA - FMD LETTER, FMD 145 10/02/2017 -
01/31/2018
AUXILILUM PHARMACEUTICALS CLINICAL TRIAL DATA TESTOPEL
01/01/1965 - 01/31/2018
2017-9594
CORR BETWEEN FDA & PURDUE PHARMA REGARDING OTR3001
DEN 130045
DENI70022
RICH PRODUCTS CORP, SEATTLE, WA - 483 01/02/2014 - 12/30/2017
RICH PRODUCTS, FOUNTAIN INN, SC - 483 01/02/2014 - 12/30/2017

RICH ICE CREAM CO, WEST PALM BEACH, FL - 483 01/02/2014 -
12/30/2017
OFFICE OF PRESCRIPTION DRUG PROMOTIONS INVESTIGATION
RICH PRODUCTS, MORRISTOWN, TN - 483 01/02/2014 - 12/30/2017
OFFICE OF PRESCRIPTION DRUG PROMOTION INVESTIGATION RECS
04/19/2017 - 01/31/2018
DR MAMORU OKI, JAPAN ETC - EIR, 483 01/01/2013 - 01/31/2018

REVIMMUNE ORPHAN DRUG APPLICATION 06/30/2010 - 07/30/2016
CENTRUM SILVER WOMEN B6 CONTENT
SCHWABE, MEXICO - 483 09/01/2017 - 09/30/2017
K172021
AMERICAN PHARMACEUTICAL INGREDIENTS LLC, WATERFORD, MI - 483
11/15/2017 - 12/14/2017
AMNEAL PHARMACEUTICALS LLC, PATERSON, NJ - 483 10/16/2017 -
10/25/2017
ASHLAND LLC, BRIDGEWATER, NJ - 483 11/07/2017 - 11/21/2017
SIDCO PHARM COMPLEX, INDIA - 483 11/27/2017 - 12/01/2017
RECS RE MEETINGS FDA ALTRIA, PMI, PHILIP MORRIS RE PMTA, MRTPA
FOR TOBACCO HEATING SYSTEM 01/01/2012 - 01/31/2018
L-GLUTAMINE ORPHAN DRUG APPLICATION, NDA 208587 REVIEW
ABBVIE, INC, NORTH CHICAGO, IL - 483 11/27/2017 - 12/15/2017

ACTAVIS LABORATORIES FL, INC, SUNRISE, FL - 483 11/29/2017 -
12/01/2017
RIGISCAN SYS K9417821
ALLURE LABS, HAYWARD, CA - 483 10/16/2017 - 10/25/2017
SAFECOR, WOBURN, MA ETC - 483, EIR 01/01/2014 - 01/31/2018
RICH PRODUCTS, MORRISTOWN, TN - 483 01/02/2014 - 12/30/2017
L1700781 - Louisburg Cider Mill STEC O157:H7 investigation
20161021MI001
PHARMATECH LLC - LAB RESULTS 01/01/2016 - 01/31/2018
ARCHIVED ENFORCEMENT REPORT 01/01/2018 - 07/31/2012
CELLTRION INC, CELLTRION HEALTHCARE, CELLTRION PHARM - EIR,
LETTER, 483 Date Range: 01/01/2015 - 02/01/2018
CHUGAI PHARMRA, JAPAN - 483 11/01/2017 - 11/30/2017
SPINEMED DECOMPRESSION TABLE, CERT HEALTH SCIENCES LLC -
CERVICAL AXIAL SPINAL DECOMPRESSION SAFETY, INDICATION OF USE,
CONTRAINDICATIONS
ANTHRAX VACCINE - INDIVIDUAL RECS
CONGRESSWOMAN MARTHA McSALLY CORR 1/15 TO PRESENT
CHOLINE CHLORIDE, SUCCINIC ACID - GRAS STATUS
CELLTRION INC, INCHEON WARNING LETTER 01/01/2018 - 01/31/2018

CELLTRION WARNING LETTER INC WARNING LETTER 01/01/2017 -
01/01/2018
CELLTRION WARNING LETTER
CELLTRION INC WARNING LETTER 01/01/2018 - 02/01/2018
DR SCOTT GOTTLIEB CALENDAR 5/9/17 TO PRESENT
CELLTRION WARNING LETTER

FDA FOIA Log FY2018

Caricato da

Informazioni sul documento

Titolo originale

Copyright

Formati disponibili

Condividi questo documento

Condividi o incorpora il documento

Opzioni di condivisione

Hai trovato utile questo documento?

Questo contenuto è inappropriato?

Copyright:

Formati disponibili

FDA FOIA Log FY2018

Caricato da

Copyright:

Formati disponibili

Control# Recd Date Requester

2017-10000 11/27/2017 Research Delta Advisors

2017-10002 11/28/2017 Alec White

2017-10009 11/28/2017 Ultralite Enterprises Inc.

2017-10011 11/28/2017 First Coast News

2017-10012 11/28/2017 Amin Talati Upadhye, LLP

2017-10014 11/28/2017 IIFL Capital

2017-10016 11/28/2017 Pennock Law Firm

2017-10023 11/28/2017 Keller and Heckman LLP

2017-10025 11/28/2017 Crossover Capital Partners

2017-10028 11/28/2017 Human Predictions LLC

2017-10030 11/28/2017 Citigroup Global Markets Pvt. Ltd. India

2017-10031 11/28/2017 Doe J

2017-10036 11/29/2017 Partner Fund Management

2017-10039 11/29/2017 Paul Rumage, Attorney at Law

2017-10042 11/29/2017 Paul Rumage, Attorney at Law

2017-10043 11/29/2017 JE Differential Trading LLC

2017-10093 12/01/2017 lynn, Catherine

2017-10094 12/01/2017 Samy Hamdouche

2017-10102 12/01/2017 Ross Feller Casey, LLP

2017-10109 12/01/2017 Ross Feller Casey, LLP

2017-10112 12/01/2017 Cognitive Research Corporation

2017-10123 12/01/2017 Susan Thixton/Association for Truth in Pet Food

2017-10127 12/01/2017 AXIS Clinicals LLC USA

2017-10129 12/01/2017 Repro-Med Systems Inc.

2017-10148 12/01/2017 MUCKROCK NEWS

2017-10150 12/01/2017 DUNN SHEEHAN LLP

2017-10153 12/01/2017 FAIRFIELD CONSULTING LLC

2017-10154 12/01/2017 O'CONNOR, NYKA

2017-10174 12/04/2017 HAYNES AND BOONE, LLP

2017-10175 12/04/2017 Ralph H Johnson VA Medical Center

2017-10178 12/04/2017 U.S. Right to Know

2017-10183 12/04/2017 The Rosen Law Firm, P.A.

2017-10187 12/04/2017 TORRENT PHARMA INC

2017-10189 12/04/2017 Bienert, Miller & Katzman, PLC

2017-10193 12/04/2017 PARAGON 28 INC

2017-10195 12/04/2017 HUI, ADA

2017-10197 12/04/2017 STEVENSON, SARAH

2017-10198 12/04/2017 STAT

2017-10206 12/04/2017 ET Now

2017-10207 12/04/2017 Crossover Capital Partners

2017-10210 12/04/2017 Labaton Sucharow LLP

2017-10211 12/04/2017 Celgene Corporation

2017-10212 12/04/2017 Celgene Corporation

2017-10218 12/04/2017 L'OREAL

2017-10220 12/04/2017 FOI Services, Inc.

2017-10224 12/04/2017 Rumrell, McLeod & Brock, PA

2017-10225 12/04/2017 Christopher Fallon

2017-10226 12/05/2017 Robert M Eddy

2017-10231 12/05/2017 Nicoletta Tulino

2017-10234 12/05/2017 Debtwire-Acuris

2017-10237 12/05/2017 CEUTICAL LABS

2017-10242 12/05/2017 STAT

2017-10243 12/05/2017 POMERANTZ LLP

2017-10245 12/05/2017 BAKER & HOSTETLER, LLP

2017-10247 12/05/2017 Choate, Hall & Stewart LLP

2017-10248 12/05/2017 Doe J

2017-10249 12/05/2017 BRIGHAM AND WOMEN'S HOSPITAL

2017-10251 12/05/2017 Crossover Capital Partners

2017-10257 12/05/2017 SPAULDING, PETER

2017-10258 12/05/2017 Northgate Technologies, Inc.

2017-10260 12/05/2017 LONDON FISCHER LLP

2017-10261 12/05/2017 Foley Baron Metzger & Juip, PLLC