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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

2017-10023 11/28/2017 Keller and Heckman LLP


2017-10024 11/28/2017 The Indian Express

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


2017-10032 11/28/2017 The Indian Express
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


2017-10037 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
2017-10050 11/29/2017 JH BARR & ASSOCIATES LLC
2017-10051 11/29/2017 JH BARR & ASSOCIATES LLC
2017-10052 11/29/2017 JH BARR & ASSOCIATES LLC
2017-10053 11/29/2017 WASHINGTON INFORMATION SOURCE
2017-10054 11/29/2017 WASHINGTON INFORMATION SOURCE
2017-10055 11/29/2017 WASHINGTON INFORMATION SOURCE
2017-10056 11/29/2017 DOMINION GROUP INC
2017-10057 11/29/2017 DOMINION GROUP INC
2017-10058 11/29/2017 DOMINION GROUP INC
2017-10059 11/29/2017 WOLTERS KLUWER LAW & BUSINESS
2017-10060 11/29/2017 WOLTERS KLUWER LAW & BUSINESS
2017-10061 11/29/2017 WOLTERS KLUWER LAW & BUSINESS
2017-10062 11/29/2017 Center for Regulator Services, Inc
2017-10063 11/29/2017 Center for Regulator Services, Inc
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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
2017-10071 11/30/2017 JH BARR & ASSOCIATES LLC
2017-10072 11/30/2017 JH BARR & ASSOCIATES LLC
2017-10073 11/30/2017 JH BARR & ASSOCIATES LLC
2017-10074 11/30/2017 JH BARR & ASSOCIATES LLC
2017-10075 11/30/2017 FOI Services, Inc.
2017-10076 11/30/2017 FOI Services, Inc.
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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
2017-10081 11/30/2017 FDA REVIEW/FDA WEBVIEW
2017-10082 11/30/2017 FDA REVIEW/FDA WEBVIEW
2017-10083 11/30/2017 FDA REVIEW/FDA WEBVIEW
2017-10084 11/30/2017 WOLTERS KLUWER LAW & BUSINESS
2017-10085 11/30/2017 WOLTERS KLUWER LAW & BUSINESS
2017-10086 11/30/2017 WOLTERS KLUWER LAW & BUSINESS
2017-10087 11/30/2017 WOLTERS KLUWER LAW & BUSINESS
2017-10088 11/30/2017 WOLTERS KLUWER LAW & BUSINESS
2017-10089 11/30/2017 Center for Regulator Services, Inc
2017-10090 11/30/2017 DOMINION GROUP INC
2017-10091 11/30/2017 FDA NEWS
2017-10092 11/30/2017 WASHINGTON INFORMATION SOURCE

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
2017-10108 12/01/2017 AMERICAN HERBAL PRODUCTS ASSOCIATION

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
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2017-10117 12/01/2017 Partner Fund Management
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2017-10119 12/01/2017 Citigroup Global Markets Pvt. Ltd. India
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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.


2017-10130 12/01/2017 IPD ANALYTICS LLC
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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
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2017-10145 12/01/2017 Micro-Tech (Nanjing) Co., Ltd.
2017-10146 12/01/2017 Micro-Tech (Nanjing) Co., Ltd.
2017-10147 12/01/2017 Micro-Tech (Nanjing) Co., Ltd.

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
2017-10163 12/04/2017 Ichorion Ventures
2017-10164 12/04/2017 Patrick Crutcher
2017-10165 12/04/2017 Salim-Beasley LLC
2017-10166 12/04/2017 Ichorion Ventures
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.
2017-10172 12/04/2017 Solaris Pharma Corporation
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
2017-10180 12/04/2017 Piramal Enterprises Limited
2017-10181 12/04/2017 Piramal Enterprises Limited
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
2017-10192 12/04/2017 FAIRFIELD CONSULTING LLC

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

2017-10207 12/04/2017 Crossover Capital Partners


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

2017-10212 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
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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


2017-10244 12/05/2017 Wilson Sonsini Goodrich & Rosati, P.C.

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


2017-10250 12/05/2017 Crossover Capital Partners

2017-10251 12/05/2017 Crossover Capital Partners


2017-10252 12/05/2017 Doe J
2017-10253 12/05/2017 Datavant
2017-10254 12/05/2017 Britton, Alma
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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.

2017-10275 12/06/2017 Entreprises Importfab Inc.


2017-10276 12/06/2017 Galt Medical Corp

2017-10277 12/06/2017 FDAZILLA

2017-10278 12/06/2017 Entreprises Importfab Inc.

2017-10279 12/06/2017 FDAZILLA

2017-10280 12/06/2017 FDAZILLA


2017-10281 12/06/2017 Micro-Tech (Nanjing) Co., Ltd.
2017-10282 12/06/2017 Micro-Tech (Nanjing) Co., Ltd.
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
2017-10292 12/06/2017 Micro-Tech (Nanjing) Co., Ltd.

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
2017-10299 12/06/2017 Micro-Tech (Nanjing) Co., Ltd.

2017-10300 12/06/2017 Conventus Biomedical Solutions, Inc.

2017-10301 12/06/2017 PETA

2017-10302 12/06/2017 Cardno ChemRisk

2017-10303 12/06/2017 Entreprises Importfab Inc.


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


2017-10321 12/07/2017 JH BARR & ASSOCIATES LLC
2017-10322 12/07/2017 JH BARR & ASSOCIATES LLC
2017-10323 12/07/2017 JH BARR & ASSOCIATES LLC
2017-10324 12/07/2017 JH BARR & ASSOCIATES LLC
2017-10325 12/07/2017 FDA REVIEW/FDA WEBVIEW
2017-10326 12/07/2017 FDA REVIEW/FDA WEBVIEW
2017-10327 12/07/2017 FDA NEWS
2017-10328 12/07/2017 FDA NEWS
2017-10329 12/07/2017 WOLTERS KLUWER LAW & BUSINESS
2017-10330 12/07/2017 WOLTERS KLUWER LAW & BUSINESS
2017-10331 12/07/2017 WOLTERS KLUWER LAW & BUSINESS
2017-10332 12/07/2017 WOLTERS KLUWER LAW & BUSINESS
2017-10333 12/07/2017 DOMINION GROUP INC
2017-10334 12/07/2017 DOMINION GROUP INC
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.
2017-10339 12/07/2017 WASHINGTON INFORMATION SOURCE
2017-10340 12/07/2017 WASHINGTON INFORMATION SOURCE
2017-10341 12/07/2017 Center for Regulator Services, Inc
2017-10342 12/07/2017 Center for Regulator 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


2017-10347 12/07/2017 University of Missouri School of Law Library
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
2017-10365 12/07/2017 Point Seven Two Asset Management
2017-10366 12/07/2017 Gamma Surgery
2017-10367 12/07/2017 Crossover Capital Partners
2017-10368 12/07/2017 ULTRADENT PRODUCTS INC
2017-10369 12/07/2017 Point Seven Two Asset Management
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


2017-10374 12/07/2017 Point Seven Two Asset Management
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


2017-10380 12/07/2017 FAIRFIELD CONSULTING LLC
2017-10381 12/07/2017 VIDA DIAGNOSTICS
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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
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2017-10395 12/08/2017 LLC
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2017-10398 12/08/2017 COGENCY GLOBAL,INC
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2017-10401 12/08/2017 KLJ Associates
2017-10402 12/08/2017 KLJ Associates
2017-10403 12/08/2017 KLJ Associates

2017-10404 12/08/2017 ASSOCIATED PRESS


2017-10405 12/08/2017 KLJ Associates
2017-10406 12/08/2017 STAT
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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

2017-10417 12/08/2017 Altria Client Services

2017-10418 12/08/2017 Liggett Vector Brands Inc.


2017-10419 12/08/2017 WOLTERS KLUWER LAW & BUSINESS
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2017-10421 12/08/2017 FDA NEWS
2017-10422 12/08/2017 FOI Services, Inc.
2017-10423 12/08/2017 Center for Regulator Services, Inc
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2017-10425 12/08/2017 DOMINION GROUP INC
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2017-10427 12/08/2017 JH BARR & ASSOCIATES LLC
2017-10428 12/08/2017 FOI Services, Inc.
2017-10429 12/08/2017 FDA REVIEW/FDA WEBVIEW
2017-10430 12/08/2017 Prateek Goyal

2017-10431 12/08/2017 Morgan Stanley

2017-10432 12/11/2017 TORRENT PHARMA INC


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
2017-10445 12/11/2017 Taylor English Duma LLP
2017-10446 12/11/2017 Teva

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2017-10448 12/11/2017 Repro-Med Systems Inc.


2017-10449 12/11/2017 Indivior Inc

2017-10450 12/11/2017 Repro-Med Systems Inc.


2017-10451 12/11/2017 Teva Pharmaceuticals
2017-10452 12/11/2017 DEKA R&D
2017-10453 12/11/2017 Hyman, Phelps, & McNamara
2017-10454 12/11/2017 Salamandra, LLC
2017-10455 12/11/2017 STERILMED
2017-10456 12/11/2017 Teva Pharmaceuticals
2017-10457 12/11/2017 FOX ROTHSCHILD LLP

2017-10458 12/11/2017 COVINGTON & BURLING 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.

2017-10464 12/11/2017 AMAG Pharmaceuticals


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.

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2018-3050 04/12/2018 PFIZER, INC

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2018-3072 04/13/2018 FROST BROWN TODD LLC
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2018-3540 05/01/2018 Waverley Pharma Inc
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2018-3551 05/01/2018 Frank Mowry

2018-3552 05/01/2018 Jefferies India

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2018-3575 05/01/2018 JUDICIAL WATCH

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2018-3578 05/01/2018 SUPERNUS PHARMACEUTICALS INC
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2018-3583 05/01/2018 LACHMAN CONSULTANT SERVICES INC


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2018-3589 05/02/2018 Clarivate Analytics

2018-359 01/11/2018 HuffPost

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2018-3592 05/02/2018 Clarivate Analytics
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2018-3596 05/02/2018 Clarivate Analytics


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2018-3622 05/02/2018 COREPHARMA LLC

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2018-3632 05/02/2018 AuroMedics Pharma LLC
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2018-3637 05/02/2018 CHARLES RIVER
2018-3638 05/02/2018 CHARLES RIVER
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2018-3651 05/03/2018 Icahn School of Medicine at Mt. Sinai
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2018-3658 05/03/2018 Sugarpod Naturals
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2018-369 01/12/2018 Nokia Digital Health

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2018-3741 05/07/2018 ROCKY MOUNTAIN POISON DRUG CTR
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2018-3847 05/09/2018 Clarivate Analytics

2018-3848 05/09/2018 Clarivate Analytics

2018-3849 05/09/2018 Clarivate Analytics

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2018-3856 05/09/2018 Clarivate Analytics

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2018-3858 05/09/2018 Clarivate Analytics


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2018-3870 05/09/2018 Faegre Baker Daniels LLP

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2018-3873 05/10/2018 Fosun Pharma USA Inc.
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2018-3876 05/10/2018 Pennock Law Firm


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2018-3900 05/10/2018 PFIZER INC
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2018-3909 05/11/2018 BD
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2018-3922 05/11/2018 Gerald A. Bagazinski

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2018-3924 05/14/2018 Suzanne Gorenfeld
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2018-3927 05/14/2018 Ori Maller

2018-3928 05/14/2018 The Tampa Bay Times

2018-3929 05/14/2018 MILWAUKEE JOURNAL SENTINEL

2018-393 01/16/2018 FOI Services, Inc.

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2018-3931 05/14/2018 Leading Pharma, LLC

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2018-3933 05/14/2018 FDAZILLA
2018-3934 05/14/2018 FDAZILLA
2018-3935 05/14/2018 FDAZILLA

2018-3936 05/14/2018 KC Pharmaceuticals, Inc


2018-3937 05/14/2018 Leading Pharma, LLC
2018-3938 05/14/2018 Leading Pharma, LLC
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2018-394 01/16/2018 Charity Aitken
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2018-3941 05/14/2018 THE UNIVERSITY OF CHICAGO

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2018-3943 05/14/2018 Pinnacle Medtech
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2018-3948 05/14/2018 UNIV OF KENTUCKY MAKRKEY CANCER CENTER
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2018-395 01/16/2018 COVINGTON & BURLING LLP
2018-3950 05/14/2018 Harrington Films

2018-3951 05/14/2018 FDAZILLA

2018-3952 05/14/2018 Susquehanna Financial Group

2018-3953 05/14/2018 LANGDON & EMISON


2018-3954 05/14/2018 ARENT FOX LLP
2018-3955 05/14/2018 Amin Talati Upadhye, LLO
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2018-396 01/16/2018 KHULLAR P.A.


2018-3960 05/14/2018 Amin Talati Upadhye, LLO
2018-3961 05/14/2018 Amin Talati Upadhye, LLO

2018-3962 05/14/2018 NBC NEWS

2018-3963 05/14/2018 Noah Wood / Wood Law Firm, LLC

2018-3964 05/14/2018 HARVARD MEDICAL SCHOOL

2018-3965 05/14/2018 Roswell Park Comprehensive Cancer Center


2018-3966 05/14/2018 COVINGTON & BURLING LLP

2018-3967 05/14/2018 Childers, Schlueter & Smith, LLC

2018-3968 05/14/2018 NBC NEWS


2018-3969 05/14/2018 WILEY REIN LLP
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2018-3979 05/14/2018 Pacific Justice Center


2018-398 01/16/2018 CASPER PHARMA LLC
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2018-3982 05/14/2018 INGENES LLC


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2018-3985 05/14/2018 INGENES LLC

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2018-4001 05/14/2018 ROANOKE CLAIMS SERVICES
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2018-4010 05/15/2018 KENNY, CHRISTOPHER
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2018-4023 05/15/2018 Dylan Bourdeau

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2018-4209 05/21/2018 Clarivate Analytics


2018-421 01/16/2018 Saptalis Pharmaceuticals LLC

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2018-4213 05/21/2018 Clarivate Analytics


2018-4214 05/21/2018 Clarivate Analytics
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2018-4224 05/21/2018 Oxygen Development LLC


2018-4225 05/21/2018 WARD #1026408, ADAM
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2018-4307 05/23/2018 UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
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2018-5563 07/10/2018 Protech Pharmaservices Corporation,Taiwan

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2018-6412 08/08/2018 PHASEBIO PHARMACEUTICALS INC


2018-6413 08/08/2018 PIERCE 163909, BRYAN
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2018-6420 08/09/2018 MITTELDEUTSCHER RUNDFUNK

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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

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2018-644 01/24/2018 LINCARE INC

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2018-6444 08/09/2018 Pamela Parham
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2018-6451 08/09/2018 Point Seven Two Asset Management


2018-6452 08/09/2018 Pura Vida Investments

2018-6453 08/09/2018 ROCKLINE INDUSTRIES

2018-6454 08/09/2018 University of Dayton

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2018-6456 08/09/2018 STOTTER & ASSOCIATES LLC
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2018-6461 08/10/2018 lisa douglass

2018-6462 08/10/2018 FARMOVS(Pty)Ltd


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2018-6465 08/10/2018 Point Seven Two Asset Management


2018-6466 08/10/2018 FDAZILLA

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2018-6471 08/10/2018 David Steinberg


2018-6472 08/10/2018 Alchem Laboratories Corporation

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2018-6483 08/10/2018 Gland Pharma Limitd


2018-6484 08/10/2018 Eric Francisco
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2018-6490 08/13/2018 Alicia Antiri

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2018-6506 08/13/2018 United Safety Agents LLC
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2018-6518 08/13/2018 WILLIS LAW GROUP

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2018-6523 08/13/2018 Eric Francisco

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2018-6525 08/13/2018 of Law
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2018-6527 08/13/2018 Teleflex Medical, Inc
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2018-6531 08/13/2018 Lincoln Diagnostics, Inc.
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2018-6535 08/13/2018 White & Case LLP
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2018-6547 08/14/2018 HORIZON PHARMA INC
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2018-655 01/25/2018 FOI Services, Inc.

2018-6550 08/14/2018 AFCEA Belvoir


2018-6551 08/14/2018 Alvarez & Marsal
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2018-6554 08/14/2018 FOI Services, Inc.
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2018-6562 08/14/2018 Mirati Therapeutics, Inc


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2018-6566 08/14/2018 Medplast Previously known as ( Vention Medical)


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2018-6578 08/14/2018 Doe J
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2018-6582 08/14/2018 PROMEDOSS INC

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2018-6584 08/14/2018 Peter Grosz

2018-6585 08/14/2018 American Oversight

2018-6586 08/15/2018 INSIDE WASHINGTON PUBLISHERS

2018-6587 08/15/2018 TruthaboutPetFood.com


2018-6588 08/15/2018 Biomedical Research Institute of America
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2018-6591 08/15/2018 Pamela Williamson

2018-6592 08/15/2018 General Mills - FSQ

2018-6593 08/15/2018 General Mills - FSQ

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2018-6619 08/15/2018 Epigenomics AG
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2018-6814 08/21/2018 Renner Capital Partners


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2018-6818 08/21/2018 Solaris Pharma Corporation
2018-6819 08/21/2018 Cogencis Information Services

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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
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2018-6829 08/21/2018 GLW, Inc

2018-683 01/25/2018 James Alexander Corporation


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2018-6838 08/21/2018 RAY THOMPSON
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2018-684 01/25/2018 COVINGTON & BURLING LLP

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2018-6850 08/21/2018 TARO PHARMACEUTICALS USA INC

2018-6851 08/21/2018 TARO PHARMACEUTICALS USA INC

2018-6852 08/21/2018 ITG BRANDS


2018-6853 08/22/2018 Bloomberg Law

2018-6854 08/22/2018 SIDLEY AUSTIN LLP


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2018-6879 08/22/2018 LUMINA HEALTH PRODUCTS INC

2018-688 01/25/2018 Crossover Capital Partners


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2018-6883 08/23/2018 Aerogen Pharma Corp
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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)


2018-689 01/25/2018 FAVUS INSTITUTIONAL RESEARCH LLC
2018-6890 08/23/2018 Hastings Law Firm PC
2018-6891 08/23/2018 STEPTOE & JOHNSON
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2018-6898 08/23/2018 AMRI SSCI, LLC

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2018-69 01/03/2018 Mark Schafer
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2018-6908 08/23/2018 Krystal Horchuck

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2018-6910 08/23/2018 Keller and Heckman LLP
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2018-6913 08/24/2018 MedReleaf Corporation
2018-6914 08/24/2018 IPD ANALYTICS LLC
2018-6915 08/24/2018 IPD ANALYTICS LLC
2018-6916 08/24/2018 IPD ANALYTICS LLC
2018-6917 08/24/2018 Anthony Roberts

2018-6918 08/24/2018 Randy Byrd, LLC


2018-6919 08/24/2018 B Zada

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2018-6920 08/24/2018 Lynne Peeples Freelance/Environmental Health News


2018-6921 08/24/2018 EZPrint Supplies

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2018-6929 08/24/2018 LATHAM & WATKINS LLP


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2018-6937 08/24/2018 FOI Services, Inc.
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2018-6940 08/24/2018 LifeSouth Community Blood Centers, Inc.

2018-6941 08/24/2018 DINSMORE & SHOHL LLP


2018-6942 08/24/2018 DiMonte & Lizak, LLC

2018-6943 08/24/2018 SIRI & GLIMSTAD LLP

2018-6944 08/24/2018 ROCKY MOUNTAIN POISON & DRUG CENTER

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

2018-6950 08/27/2018 Senvest Management LLC

2018-6951 08/27/2018 Scott A. Hodes, Attorney at Law


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

2018-6958 08/27/2018 Kaiser Health News

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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

2018-6964 08/27/2018 Harrington Films


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


INTERNATIONAL CONSORTIUM OF INVESTIGATIVE
2018-6969 08/28/2018 JOURNALISTS

2018-697 01/25/2018 BLANK ROME LLP

2018-6970 08/28/2018 Faegre Baker Daniels LLP


2018-6971 08/28/2018 Christina Chow
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2018-6972 08/28/2018 (PCAA)
2018-6973 08/28/2018 Wright Foods
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2018-6975 08/28/2018 Perry, Rachel

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2018-6977 08/28/2018 Clarivate Analytics


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

2018-6982 08/28/2018 Clarivate Analytics

2018-6983 08/28/2018 Clarivate Analytics

2018-6984 08/28/2018 Lynne Peeples Freelance/Environmental Health News

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

2018-6990 08/28/2018 IOVATE HEALTH SCIENCES INTERNATIONAL INC


2018-6991 08/28/2018 FDAZILLA
2018-6992 08/28/2018 IOVATE HEALTH SCIENCES INTERNATIONAL INC

2018-6993 08/29/2018 Mallory Ulmer

2018-6994 08/29/2018 FDA Aerospace Solutions

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
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Brigham and Women's Hospital, Division of
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2018-7000 08/29/2018 Murray Carpenter


2018-7001 08/29/2018 Alnylam Pharmaceuticals

2018-7002 08/29/2018 Aurobindo Pharma USA Inc.


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
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2018-7008 08/29/2018 HUMPHREY, MIKE
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2018-702 01/25/2018 FARUQI & FARUQI LLP
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2018-7022 08/30/2018 MUCKROCK
2018-7023 08/30/2018 SANTIAGO, WENDY
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2018-7042 09/04/2018 FDAZILLA

2018-7043 09/04/2018 Cogencis Information Services


2018-7044 09/04/2018 Ceva Animal Health

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2018-7049 09/04/2018 Kleinfeld, Kaplan & Becker LLP

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2018-7094 09/05/2018 barbara kurys

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2018-7096 09/05/2018 BloombergQuint
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2018-7098 09/05/2018 Equirus Capital
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2018-7100 09/05/2018 Dr Ajay Phadke
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2018-7103 09/05/2018 PHARM3R

2018-7104 09/05/2018 Reveal + The Center for Investigative Reporting


2018-7105 09/05/2018 Doe J
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2018-7114 09/05/2018 LEWIS BRISBOIS ET AL

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2018-7116 09/06/2018 MEDTRONIC
2018-7117 09/06/2018 BRIDGER CAPITAL LLC
2018-7118 09/06/2018 B&H Consulting Services - Sean Decker
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2018-712 01/26/2018 ET Now
2018-7120 09/06/2018 B Zada
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2018-7122 09/06/2018 The Law Office of Benjamin Korn, PLLC

2018-7123 09/06/2018 Alicia Antiri


2018-7124 09/06/2018 PURDUE UNIVERSITY
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2018-7135 09/07/2018 Bank of America Merrill Lynch


2018-7136 09/07/2018 FDAAWARE
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2018-7146 09/07/2018 Point Seven Two Asset Management
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2018-7152 09/07/2018 Interchem Corp
2018-7153 09/07/2018 MAQUET Cardiovascular, LLC

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2018-7162 09/07/2018 of Medicine, Division of Hematology/Oncology
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2018-7174 09/07/2018 ALLIANCE FOR NATURAL HEALTH USA

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2018-7178 09/07/2018 FOLEY & LARDNER LLP

2018-7179 09/10/2018 Scott A. Hodes, Attorney at Law


2018-718 01/26/2018 UNIVERSITY OF SOUTHERN CALIFORNIA
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2018-7190 09/10/2018 Osler, Hoskin & Harcourt LLP

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2018-7196 09/10/2018 AMAG Pharmaceuticals


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2018-7217 09/10/2018 KONIGSTEIN, DAVID
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2018-7247 09/11/2018 Gnosiis International, LLC


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2018-7252 09/11/2018 FDAZILLA

2018-7253 09/11/2018 Lynne Peeples Freelance/Environmental Health News


2018-7254 09/11/2018 Biomedical Research Institute of America

2018-7255 09/11/2018 COVINGTON & BURLING LLP


2018-7256 09/11/2018 FourWorld Capital Management
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2018-7265 09/11/2018 FDAZILLA

2018-7266 09/11/2018 FDAZILLA

2018-7267 09/11/2018 Journal of Physical Security


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2018-7309 09/12/2018 SIRI & GLIMSTAD LLP

2018-731 01/26/2018 THOMSON REUTERS (SCIENTIFIC) SAS


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

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2018-7316 09/12/2018 CITIZENS COMMISSION ON HUMAN RIGHTS INTERNATIONAL


2018-7317 09/12/2018 LEVIN PAPANTONIO ET AL
2018-7318 09/13/2018 Doe J
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2018-732 01/26/2018 Cogencis Information Services
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2018-7322 09/13/2018 Clarivate Analytics
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2018-7333 09/13/2018 Newsy
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2018-7337 09/13/2018 Hyman Phelps & McNamara


2018-7338 09/13/2018 Edenbridge Pharmaceuticals LLC
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2018-7339 09/13/2018 Cancer Center
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2018-7340 09/13/2018 Raymond James
2018-7341 09/13/2018 Sunground Risk Control Robot(SGRCR)
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2018-7353 09/13/2018 HADLEY, KEITH
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2018-7358 09/13/2018 ASHCRAFT & GEREL LLP


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2018-736 01/26/2018 BRIDGER CAPITAL LLC


2018-7360 09/13/2018 BRIGHAM & WOMEN'S HOSPITAL, BLOOD BANK
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2018-7385 09/14/2018 SMITHS MEDICAL ASD INC


2018-7386 09/14/2018 StimAire
2018-7387 09/14/2018 Lupin Pharmaceutical

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2018-7389 09/14/2018 Solaris Pharma Corporation


2018-739 01/26/2018 The Dominion Group
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2018-740 01/26/2018 BRIDGER CAPITAL LLC

2018-7400 09/17/2018 AKIN GUMP STRAUSS HAUER & FELD LLP


2018-7401 09/17/2018 Dawn Firsingparis

2018-7402 09/17/2018 AKIN GUMP STRAUSS HAUER & FELD LLP

2018-7403 09/17/2018 Thompson Coburn LLP, Ms. Eileen E. Boyle Perich


2018-7404 09/17/2018 The Capitol Forum

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2018-7406 09/17/2018 VERNON & DURAY LLP
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2018-7408 09/17/2018 MULLER BRAZIL LLP
2018-7409 09/17/2018 jonathan sackner-bernstein

2018-741 01/26/2018 THOMSON REUTERS


2018-7410 09/17/2018 Darsana Capital Partners
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

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2018-7417 09/17/2018 Renner Capital Partners


2018-7418 09/17/2018 Joshua Insel
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2018-742 01/26/2018 BRIDGER CAPITAL LLC

2018-7420 09/17/2018 CTI Clinical Trial & Consulting Services

2018-7421 09/17/2018 Hedgeye Risk Management LLC

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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


National Institute of Securities Markets, Navi
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
2018-800 01/31/2018 Agios Pharmaceuticals
2018-801 01/31/2018 Align Technology
2018-802 01/31/2018 Bryan Sullivan
2018-803 01/31/2018 Burdock Group Consultants
2018-804 01/31/2018 Tremont Therapeutics Consulting

2018-805 01/31/2018 Kaiser Health News


2018-806 01/31/2018 Carissa Rossi

2018-807 01/31/2018 Agios Pharmaceuticals


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.
2018-813 02/01/2018 Glenmark Pharmaceuticals Inc., USA

2018-814 02/01/2018 Patients For Affordable Drugs


2018-815 02/01/2018 Dr. Reddy's Laboratories Inc.

2018-816 02/01/2018 The Rosen Law Firm


2018-817 02/01/2018 Dr. Reddy's Laboratories Inc.
2018-818 02/01/2018 Aavis Pharmaceuticals
2018-819 02/01/2018 Theresa M Labbe, MD
2018-82 01/03/2018 Gardner Law, PLLC
2018-820 02/01/2018 Dr. Reddy's Laboratories Inc.
2018-821 02/01/2018 Ethypharm USA Corp
2018-822 02/01/2018 Ethypharm USA Corp
2018-823 02/01/2018 Doe J

2018-824 02/01/2018 OLSSON FRANK WEEDA TERMAN MATZ PC


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
2018-829 02/01/2018 Dr. Reddy's Laboratories Inc.
2018-83 01/03/2018 Paritic Inc.
2018-830 02/01/2018 Reuters News
2018-831 02/01/2018 Sysmex America, Inc.

2018-832 02/01/2018 Matt Philippe


2018-833 02/01/2018 Reuters News
2018-834 02/01/2018 Kashiv Pharma, LLC

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

2018-84 01/03/2018 Hyman Phelps & McNamara


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

2018-843 02/01/2018 TARO PHARMACEUTICALS USA INC

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
2018-847 02/01/2018 LEVIN PAPANTONIO ET AL
2018-848 02/01/2018 HUSCH BLACKWELL LLP
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

2018-851 02/02/2018 GOODWIN PROCTER LLP


2018-852 02/02/2018 Rawls Law Group PC

2018-853 02/02/2018 Wilson Sonsini Goodrich & Rosati, P.C.


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
2018-858 02/02/2018 PuraCap Pharmaceutical, LLC
2018-859 02/02/2018 Oxford & Wells
2018-86 01/03/2018 Gardner Law, PLLC
2018-860 02/02/2018 Westwood Advisors Incorporated

2018-861 02/02/2018 OLSSON FRANK WEEDA TERMAN MATZ PC


2018-862 02/02/2018 Squaxin Island Tribe
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

2018-866 02/02/2018 Bridger Management, LLC

2018-867 02/02/2018 Alicia Antiri


2018-868 02/02/2018 BASF Corporation

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
2018-873 02/02/2018 ROBBINS ARROYO LLP

2018-874 02/02/2018 BLOOMBERG NEWS

2018-875 02/02/2018 LEE & HAYES


2018-876 02/02/2018 Aristotle Capital Management

2018-877 02/02/2018 FOI Services, Inc.


2018-878 02/02/2018 STRYKER ORTHOPAEDICS

2018-879 02/02/2018 OLSSON FRANK WEEDA TERMAN MATZ PC


2018-88 01/03/2018 Gardner Law, PLLC
2018-880 02/02/2018 FOLEY & LARDNER LLP

2018-881 02/02/2018 SIDLEY AUSTIN LLP


2018-882 02/02/2018 FOLEY & LARDNER LLP
2018-883 02/02/2018 FOLEY & LARDNER LLP
2018-884 02/02/2018 Penn Law LLC
2018-885 02/02/2018 FOLEY & LARDNER LLP
2018-886 02/02/2018 Cutera, Inc.

2018-887 02/02/2018 WEST, AMY


2018-888 02/02/2018 Jon Knight
2018-889 02/02/2018 University of Helsinki (FINLAND)
2018-89 01/03/2018 Mark Schafer

2018-890 02/02/2018 Penn Law LLC


2018-891 02/02/2018 JAMIESON NATURAL SOURCES
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
2018-895 02/05/2018 SCHULTE, ROTH & ZABEL LLP

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
2018-900 02/05/2018 THOMSON REUTERS
2018-901 02/05/2018 Doe J
2018-902 02/05/2018 KM PHARMACEUTICAL CONSULTING LLC
2018-903 02/05/2018 KM PHARMACEUTICAL CONSULTING LLC

2018-904 02/05/2018 HAW-DU-I FOODS CO., LTD

2018-905 02/05/2018 BAXTER HEALTHCARE CORPORATION


2018-906 02/05/2018 Bio-Pharm, Inc
2018-907 02/05/2018 Solve Consulting International Pty Ltd
Medivators Inc./SPS Medical subsidiary of
2018-908 02/05/2018 Crosstex Inc.
2018-909 02/05/2018 Keller and Heckman LLC
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

2018-914 02/05/2018 Cogencis Information Services


2018-915 02/05/2018 Quinn Eastman
2018-916 02/05/2018 Kashiv Pharma, LLC
2018-917 02/05/2018 IPD ANALYTICS LLC
2018-918 02/05/2018 IPD ANALYTICS LLC
2018-919 02/05/2018 BAKER & HOSTETLER, LLP
2018-92 01/03/2018 Chardan
2018-920 02/05/2018 Dr. Reddy's Laboratories Inc.

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
2018-930 02/05/2018 THOMSON REUTERS

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


2018-936 02/05/2018 King & Spalding LLP
2018-937 02/05/2018 FOIA Professional Services
2018-938 02/05/2018 FOIA Professional Services
2018-939 02/05/2018 FOIA GROUP INC
2018-94 01/03/2018 LACHMAN CONSULTANT SERVICES INC

2018-940 02/05/2018 Center for Regulatory Services Inc.


2018-941 02/05/2018 MORGAN LEWIS & BOCKIUS LLP

2018-942 02/05/2018 Wilkes & McHugh, PA


2018-943 02/05/2018 Align Technology
2018-944 02/05/2018 FOI Services, Inc.

2018-945 02/05/2018 HOGAN LOVELLS US LLP

2018-946 02/05/2018 Russ Kick

2018-947 02/05/2018 Department of Finance, Insurance, and Real Estate


2018-948 02/05/2018 Wilson, Sonsini, Goodrich & Rosati
2018-949 02/05/2018 MILWAUKEE JOURNAL SENTINEL
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

2018-955 02/06/2018 Aerie Pharmaceuticals, Inc.

2018-956 02/06/2018 Aerie Pharmaceuticals, Inc.


2018-957 02/06/2018 Crossover Capital Partners

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


2018-965 02/06/2018 GOODWIN PROCTER LLP
2018-966 02/06/2018 margaret groel

2018-967 02/06/2018 GOODWIN PROCTER LLP

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


2018-987 02/06/2018 Xpro Associates LLC
2018-988 02/06/2018 MARTIN GANOTIS BROWN MOULD & CURRIE PC
2018-989 02/06/2018 KELLEY, MEGAN JEAN
2018-99 01/03/2018 DEMOCRATIC SENATORIAL CAMPAIGN COMMITTEE
2018-990 02/06/2018 JANTAR GMBH
2018-991 02/06/2018 Partner Fund Management

2018-992 02/06/2018 Darsana Capital Partners

2018-993 02/06/2018 POINTSTATE CAPITAL LP


2018-994 02/06/2018 BLOOMBERG NEWS
2018-995 02/06/2018 THOMSON REUTERS
2018-996 02/06/2018 Cherrystone Hill Capital Management LLC
2018-997 02/06/2018 STAT
2018-998 02/06/2018 Guggenheim Securities, LLC
2018-999 02/06/2018 Hyman Phelps & McNamara
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 11/6-10/17
CLOSED LOG 10/16-20/17
CLOSED LOG 10/23-27/17
CLOSED LOG 10/30/17-11/3/17
CLOSED LOG 11/6-10/17
DAILY LOG 11/6-10/17
CLOSED LOG 10/16-20/17
CLOSED LOG 10/23-27/17
CLOSED LOG 10/30/17-11/3/17
CLOSED LOG 11/6-10/17
CLOSED LOG 10/16-20/17
CLOSED LOG 10/23-27/17
CLOSED LOG 10/30/17-11/3/17
DAILY LOG 11/6-10/17
CLOSED LOGS 11/6-10/17
DAILY LOG 11/6-10/17
DAILY LOG 11/6-10/17
DAIL LOG 11/6-10/17
DAILY 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
483 RELEASED UNDER FOIA 10/30/2017 - 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
CLOSED LOG 11/13-17/17
DAILY LOG 11/13-17/17
DAILY LOG 11/20-24/17
CLOSED LOG 11/20-24/17
CLOSED LOG 11/13-17/17
CLOSED LOG 11/20-24/17
DAILY LOG 11/13-17/17
DAILY LOG 11/20-24/17
DAILY LOG 11/13-17/17
CLOSED LOG 11/13-17/17
DAILY LOG 11/20-24/17
CLOSED LOG 11/20-24/17
DAILY LOG 11/13-17/17
DAILY LOG 11/20-24/17
CLOSED LOG 11/13-17/17
DAILY LOG 11/13-17/17
DAILY LOG 11/20-24/17
CLOSED 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

SHILPA MEDICARE LTD, INDIA - 483 11/20/2017 - 12/01/2017


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

SHILPA MEDICARE, TELANGANA, INDIA - 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
SUN PHARMA, BASKA, INDIA - 483 11/10/2017 - 12/07/2017
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
CLOSED FOI REQUESTS 11/27/17-12/1/17
CLOSED FOI REQUESTS 11/27/17-12/1/17
CLOSED FOI REQUESTS 11/27/17-12/1/17
SHILPA MEDICARE, TELANGANA, INDIA - 483 11/01/2017 - 12/07/2017

SHILPA MEDICARE, TELANGANA, INDIA - 483 11/01/2017 - 12/07/2017


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
SHILPA MEDICARE, INDIA - 483 10/01/2017 - 12/08/2017
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
PHILIPS MEDICAL SYSTEMS, CLEVELAND, OH - 483 07/01/2017 -
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
Technical Project Lead Reports and decision summaries to the
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
Technical Project Lead Reports and decision summaries to the
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
Technical Project Lead Reports and decision summaries to the
one (1) Not Substantially Equivalent (NSE) Order issued in
October 2017
K163484
Technical Project Lead Reports and decision summaries to the
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
LISTING OF INSPECTIONS 12/15/2016 - 12/15/2017
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
DR REDDY'S, DUVVADA, INDIA - EIR 11/01/2017 - 12/18/2017
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
ANDA 205948 EFFECTIVE APPROVAL LETTER
MIDWEST VETERINARY SERVICES, OAKLAND, NE - 483, 482, ETC
07/01/2015 - 12/15/2017
Technical Project Lead Reports and decision summaries to the
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
ANDA 206888 TENTATIVE APPROVAL LETTER
FDA-2015-P-2676 FDA-2014-P-1400
Technical Project Lead Reports and decision summaries to the
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
Technical Project Lead Reports and decision summaries to the
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
ANDA 078005 EFFECTIVE APPROVAL LETTER

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
September 28 2017 including sample number, sample description,
and date tested
List of samples tested for robenidine between Jan 1 2014 and
September 28 2017 including sample number, sample description,
and date tested
List of samples tested for monensin between Jan 1 2014 and
September 28 2017 including sample number, sample description,
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
September 28 2017 including sample number, sample description,
and date tested
RECS RE DEN120017
List of samples tested for salinomycin between Jan 1 2014 and
September 28 2017 including sample number, sample description,
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
September 28 2017 including sample number, sample description,
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
September 28 2017 including sample number, sample description,
and date tested
List of samples tested for imidocarb between Jan 1 2014 and
September 28 2017 including sample number, sample description,
and date tested
List of samples tested for nicarbazine between Jan 1 2014 and
September 28 2017 including sample number, sample description,
and date tested
List of samples tested for lasalocid between Jan 1 2017 and
September 28 2017 including sample number, sample description,
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
September 28 2017 including sample number, sample description,
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
ENFORCEMENT REPORT DATA
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
PHILIPS MEDICAL SYSTEMS, CLEVELAND, OH - 483 01/01/2016 -
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
GLATOPA, GLATIRAMER ACETATE, COPAXONE 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
CLOSED LOG 9/11-15/17
DAILY LOG 9/11-15/17
CLOSED LOG 9/18-22/17
DAILY LOG 9/18-22/17
CLOSED LOG 9/11-15/17
CLOSED LOG 9/18-22/17
DAILY LOG 9/11-15/17
DAILY LOG 9/18-22/17
DAILY LOG 9/11-15/17
DAILY LOG 9/18-22/17
CLOSED LOG 9/11-15/17
DAILY LOG 9/11-15/17
CLOSED LOG 9/18-22/17
DAILY LOG 9/18-22/17
DAILY LOG 9/11-15/17
DAILY LOG 9/18-22/17
DAILY LOG 9/11-15/17
CLOSED LOG 9/11-15/17
DAILY LOG 9/18-22/17
CLOSED LOG 9/18-22/17
DAIL LOG 9/11-15/17
DAILY LOG 9/18-22/17
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
2017-7504 REQUEST LETTER ONLY
2017-8061 REQUEST LETTER ONLY
ANGIO DYNAMICS INC K151724
2017-7658 REQUEST LETTER ONLY
2017-7603 REQUEST LETTER ONLY
2017-7917 REQUEST LETTER ONLY
ANGIO DYNAMICS K061733
2017-7825 REQUEST LETTER ONLY
2017-7574 REQUEST LETTER ONLY
2017-8116 REQUEST LETTER ONLY
2017-7843 REQUEST LETTER ONLY
2017-8136 REQUEST LETTER ONLY
2017-8271 REQUEST LETTER ONLY
ANGIO DYNAMICS INC K112452
2017-7763 REQUEST LETTER ONLY
2017-7926 REQUEST LETTER ONLY
ANGIO DYNAMICS INC K161596
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
LIST OF INSPECTIONS 08/01/2017 - 09/30/2017
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
FOIA LOG ABBOTT LABORATORIES 10/03/2017 - 10/16/2017
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
FDA FOIA LOG ST JUDE MEDICAL 10/03/2017 - 10/16/2017
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
ANDA 203880 ANDA 207606 ANDA 204561 ETC
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
ANDA 204383 TENTATIVE APPROVAL LETTER
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
FOI DAILY LOG 10/1-31/2017

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
FDA FOIA LOG ST JUDE MEDICAL 10/17/2017 - 10/30/2017
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
483 RELEASED UNDER FOIA 10/27/2017 - 11/03/2017
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
LIST OF INSPECTIONS 11/05/2016 - 11/05/2017
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


INTERSECT ENT, MENLO PARK, CA - 483 11/01/2017 - 11/07/2017
APPROVAL LETTERS NDA 021146 SUPPL-17 SUPPL-18
INTERSECT ENT, MENLO PARK, CA - 483 10/06/2017 - 11/06/2017
RECALL DATA
Roche Athena Protocol for HPV BD HPV Protocol #BDS-USHPV for
Study Protocol for HPV-GT Viper Assay
WARNING LETTER SPREADSHEET
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
FOI DAILY LOG 9/25-29/17
FOI DAILY LOG 9-25-29-17
FOI DAILY LOG 9-25-29-17
FOI DAILY LOG 9-25-29-17
FOI DAILY LOG 9-25-29-17
FOI DAILY LOG 9-25-29-17
FOI DAILY LOG 10-2-6-17
FOI DAILY LOG 10-2-6-17
FOI DAILY LOG 10-2-6-17
FOI DAILY LOG 10-2-6-17
FOI DAILY LOG 10-2-6-17
FOI DAILY LOG 10-2-6-17
FOI DAILY LOG 10-2-6-17
FOI DAILY LOG 10-9-13-17
FOI DAILY LOG 10-9-13-17
FOI DAILY LOG 10-9-13-17
FOI DAILY LOG 10-9-13-17
FOI DAILY LOG 10-9-13-17
FOI DAILY LOG 10-9-13-17
FOI DAILY LOG 10-9-13-17
CLOSED FOI REQUESTS 9-25-29-17
CLOSED FOI REQUESTS 9-25-29-17
CLOSED FOI REQUESTS 9-25-29-17
CLOSED FOI REQUESTS 9-25-29-17
CLOSED FOI REQUESTS 9-25-29-17
CLOSED FOI REQUESTS 10-2-6-17
CLOSED FOI REQUESTS 10-2-6-17
CLOSED FOI REQUESTS 10-2-6-17
CLOSED FOI REQUESTS 10-9-13-17
CLOSED FOI REQUESTS 10-9-13-17
CLOSED FOI REQUESTS 10-9-13-17
CLOSED FOI REQUESTS 10-9-13-17
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
FDA FOIA LOG ABBOTT LABORATORIES 10/31/2017 - 11/12/2017
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 SBA

FRESENIUS KABI USA - BORTEZOMIB NDA 205-004 APRVL LTR 11/6/17


FRESENIUS KABI USA - BORTEZOMIB NDA 205-004 SBA
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
PHILIPS MEDICAL SYSTEMS, CLEVELAND, OH - 483 07/01/2017 -
11/15/2017
RTI SURGICAL INC, ALACHUA, FL - EIR, 483, CORR 4/28/17
SUN PHARMA, BASKA, INDIA - 483 11/01/2017 - 11/15/2017

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
SUN PHARMA, BASKA, INDIA - 483 11/01/2017 - 11/17/2017
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
2017-8518 REQUEST LETTER ONLY
2017-8532 REQUEST LETTER ONLY
2017-8621 REQUEST LETTER ONLY
2017-8644 REQUEST LETTER ONLY
2017-8715 REQUEST LETTER ONLY
2017-8736 - REQUEST LETTER ONLY
2017-8743 - REQUEST LETTER ONLY
2017-8788 - REQUEST LETTER ONLY
2017-8802 - REQUEST LETTER ONLY
2017-9203 - REQUEST LETTER ONLY
2017-8819 - REQUEST LETTER ONLY
2017-8970 - REQUEST LETTER ONLY
2017-8971 - REQUEST LETTER ONLY
2017-8974 - REQUEST LETTER ONLY
2017-9056 - REQUEST LETTER ONLY
2017-9064 - REQUEST LETTER ONLY
2017-9137 - REQUEST LETTER ONLY
2017-9095 - REQUEST LETTER ONLY
2017-9105 - REQUEST LETTER ONLY
2017-9156 - REQUEST LETTER ONLY
2017-9162 - REQUEST LETTER ONLY
2017-9164 - REQUEST LETTER ONLY
2017-9169 - 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
LIST OF INSPECTIONS 11/26/2016 - 11/26/2017
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
DR REDDY'S, DUVVADA, INDIA - EIR 11/01/2017 - 11/21/2017
EPIPEN ADVERSE EVENTS
INDIVIDUAL RECS
INDIVIDUAL RECS
CELLTRION WARNING LETTER 01/01/2018 - 02/02/2018
CFSAN FOIA REQUESTS 01/17/2018 - 01/31/2018
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
WARNING LETTER SPREADSHEET
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
CELLTRION WARNING LETTER 01/01/2018 - 02/02/2018

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
LIST OF INSPECTIONS 12/01/2017 - 01/31/2018
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
ANDA APPROVAL LETTERS
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 1/15-19/18
DAILY LOG 1/8-12/18
DAILY LOG 1/22-26/18
DAILY LOG 1/29/18-2/2/18
DAILY LOG 1/8-12/18
HHSF223200850014I, HHSF22301001T
DAILY LOG 1/15-19/18
DAILY LOG 1/22-26/18
DAILY LOG 1/2918-2/2/18
DAILY LOG 1/15-19/18
DAILY LOG 1/22-26/18
DAILY LOG 1/29/19-2/2/18
DAILY LOG 1/8-12/18
DAILY LOG 1/15-19/18
DAILY LOG 1/22-26/18
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 1/15-19/18
DAILY LOG 1/22-26/18
DAILY LOG 1/29/18-2/2/18
DAILY LOG 1/15-19/18
DAILY LOG 1/22-26/18
DAILY LOG 1/29/18-2/2/18
DAILY LOG 1/15-19/18
DAILY LOG 1/22-26/18
DAILY LOG 1/29/18-2/2/18
SELENOMETHIONINE FOOD ADDITIVES 01/01/1998 - 12/28/2017
FOIA LOG ABBOTT LABORATORIES 01/01/2018 - 01/31/2018
FOIA LOG ST JUDE MEDICAL 12/26/2017 - 01/31/2018
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 1/15-19/18
CLOSED FOIA REQUESTS 1/1-5/18
CLOSED FOIA REQUESTS 1/22-26/18
CLOSED FOIA REQUESTS 1/29/18-2/2/18
FOI DAILY LOG 1/1-5/18
CLOSED FOIA REQUESTS 1/1-5/18
CLOSED FOIA REQUESTS 1/8-12/18
CLOSED FOIA REQUESTS 1/15-19/18
CLOSED FOIA REQUESTS 1/22-26/18
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
FOI DAILY LOG 1/1-5/18
FOI DAILY LOG 1/8-12/18
CLOSED FOIA REQUESTS 1/1-5/18
CLOSED FOIA REQUESTS 1/8-12/18
CLOSED FOIA REQUESTS 1/15-19/18
CLOSED FOIA REQUESTS 1/22-26/18
CLOSED FOIA REQUESTS 1/29/18-2/2/18
FOI DAILY LOG 1/1-5/18
CLOSED FOIFA REQUETS 1-1-5/18
CLOSED FOIA REQUESTS 1/8-12/18

OOPD FDA, Designation Review -- Points to Consider (Jan 1993)


CLOSED FOIA REQUESTS 1/15-19/18
CLOSED FOIA REQUESTS 1/22-26/18
CLOSED FOIA REQUESTS 1/29/18-2/2/18
FOI DAILY LOG 1/1-5/18
FOI DAILY LOG 1/8-12/18
FOI DAILY LOG 1/1-5/18
FOI DAILY LOG 1/8-12/18
FOI DAILY LOG 1/1-5/18
FOI DAILY LOG 1/1-5/18
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
CONSUMER COMPLAINT 152299
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
FOIA LOG ABBOTT LABORATORIES 11/27/2017 - 12/26/2017
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
FOIA LOG ST JUDE MEDICAL 11/27/2017 - 12/26/2017

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
LIST OF INSPECTIONS 11/01/2017 - 12/31/2017
AUROBINDO PHARMA, UNIT 4 SUN PHARMA, HALOL NATCO PHARMA,
MEKAGUDA - 483 01/15/2018 - 02/16/2018
EXONDYS 51 - REVIEW OF SUPPLEMENT
LISTING OF INSPECTIONS 02/15/2017 - 02/15/2018
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
LIST OF INSPECTIONS 01/01/2017 - 01/01/2018
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
WARNING LETTER SPREADSHEET
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
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
GLATOPA, GLATIRAMER ACETATE, COPAXONE AERS
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
ANDA APPROVAL LETTERS
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
AUROBINDO, UNIT 4 INDIA - 483 02/10/2018 - 02/21/2018
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
SUN PHARMA, HALOL, INDIA - 483 02/12/2018 - 02/23/2018
SUN PHARMA, HALOL, INDIA - 483 02/12/2018 - 02/23/2018
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 PHARMA, HALOL, INDIA - 483 02/10/2018 - 02/24/2018
SUN PHARMACEUTICALS LTD, HALOL, INDIA - 483 02/01/2018 -
02/23/2018
NDA 20222
SUN PHARMACEUTICALS LTD, HALOL, INDIA - 483 02/01/2018 -
02/23/2018
SUN PHARMACEUTICALS LTD, HALOL, INDIA - 483 02/01/2018 -
02/23/2018
BIOCON, MALAYSIA - 483 07/01/2017 - 02/23/2018
SANDOZ GMBH, AUSTRIA - 483, EIR 01/21/2016 - 01/29/2016
SUN PHARMACEUTICALS LTD, HALOL, INDIA - 483 02/01/2018 -
02/23/2018
SUN PHARMACEUTICALS LTD, HALOL, INDIA - 483 02/01/2018 -
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
SUN PHARMACEUTICALS LTD, HALOL, INDIA - 483 02/01/2018 -
02/23/2018
SUN PHARMACEUTICALS LTD, HALOL, INDIA - 483 02/01/2018 -
02/23/2018
SUN PHARMACEUTICALS LTD, HALOL, INDIA - 483 02/01/2018 -
02/23/2018
SUN PHARMACEUTICALS LTD, HALOL, INDIA - 483 02/01/2018 -
02/23/2018
SUN PHARMACEUTICALS LTD, HALOL, INDIA - 483 02/01/2018 -
02/23/2018
SUN PHARMACEUTICALS LTD, HALOL, INDIA - 483 02/01/2018 -
02/23/2018
AUROBINDO UNIT 4, INDIA - 483 02/01/2018 - 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

SUN PHARMA HALOL, INDIA - 483 02/01/2018 - 02/23/2018


OTSUKA PHARMACEUTICAL, JAPAN - 483 12/01/2017 - 12/31/2017
SUN PHARMA HALOL, INDIA - 483 02/01/2018 - 02/23/2018
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
SUN PHARMA, HALOL, INDIA - 483 02/01/2018 - 02/23/2018
SUN PHARMA, HALOL, INDIA - 483 02/01/2018 - 02/23/2018
AUROBINDO PHARMA LTD, UNIT IV, INDIA - 483 02/12/2018 -
02/23/2018
SUN PHARMA, HALOL, INDIA - 483 02/01/2018 - 02/23/2018
COOK INCORPORATED, ELLETTSVILLE, IN - EIR 09/24/2010 -
10/05/2010
SUN PHARMA, HALOL, INDIA - 483 02/01/2018 - 02/23/2018
INDIVIDUAL RECS
SUN PHARMA, HALOL, INDIA - 483 02/01/2018 - 02/23/2018
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
SUN PHARMACEUTICALS INDUSTRIES, HALOL, INDIA - 483 02/01/2018
- 02/23/2018
SUN PHARMACEUTICALS INDUSTRIES, HALOL, INDIA - 483 02/01/2018
- 02/23/2018
SUN PHARMACEUTICALS INDUSTRIES, HALOL, INDIA - 483 02/01/2018
- 02/23/2018
SUN PHARMACEUTICALS INDUSTRIES, HALOL, INDIA - 483 02/01/2018
- 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
FDA FOIA LOG ABBOTT LABORATORIES 02/01/2018 - 02/28/2018

SUN PHARMACEUTICALS, HALOL, INDIA - 483 02/01/2018 - 03/06/2018


FOIA LOG ST JUDE MEDICACL 02/01/2018 - 02/28/2018
SUN PHARMA, HALOL, INDIA - 483 02/01/2018 - 02/28/2018
ANADA 100-237
K831000
NDA 203340
SUMMARY OF SAFETY AND EFFECTIVENESS P850035
K121166
2016-6969

AUROBINDO PHARMA UNIT IV, INDIA - 483 02/01/2018 - 02/28/2018


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
ANDA 208875 TENTATIVE APPROVAL LETTER
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
ANDA 208934 TENTATIVE APPROVAL LETTER
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
ANDA 206447 TENTATIVE APPROVAL LETTER
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
SUN PHARMA, HALOL, INDIA - 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
ENFORCEMENT REPORT RECS 10/01/2011 - 03/01/2018
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
SUN PHARMA, HALOL, INDIA - 483 02/01/2018 - 03/01/2018
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
AUROBINDO UNIT 4, INDIA - 483 02/01/2018 - 03/02/2018
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
SUN PHARMA, HALOL, INDIA - 483 02/01/2018 - 02/28/2018
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
CFSAN FOIA REQUESTS 02/01/2018 - 02/28/2018
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
ENFORCEMENT REPORT DATA
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
FOI DAILY LOG 2/5-9/18
FOI DAILY LOG 2/5-9/18
FOI DAILY LOG 2/5-9/18
FOI DAILY LOG 2/5-9/18
ARBOR PHARMS - ERYTHROMYCIN GRANULES FOR SUSPENSION NDA 50-207
SBA
FOI DAILY LOG 2/5-9/18
FOI DAILY LOG 2/5-9/18
FOI DAILY LOG 2/5-9/18
FOI DAILY LOG 2/12-16/18
FOI DAILY LOG 2/12-16/18
FOI DAILY LOG 2/12-16/18
FOI DAILY LOG 2/12-16/18
FOI DAILY LOG 2/12-16/18
FOI DAILY LOG 2/12-16/18
FOI DAILY LOG 2/12-16/18
VOLUNTARY CONSMETIC REGISTRATION PROGRAM (VCRP) - USE TOTALS,
INGREDIENT, CATEGORY TOTALS, ETC
CLOSED FOI REQUESTS 2/5-9/18
CLOSED FOI REQUESTS 2/5-9/18
CLOSED FOI REQUESTS 2/5-9/18
CLOSED FOI REQUESTS 2/5-9/18
CLOSED FOI REQUESTS 2/12-16/18
CLOSED FOI REQUESTS 2/12-16/18
CLOSED FOI REQUESTS 2/12-16/18
CLOSED FOI REQUESTS 2/12-16/18
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
BE review for ANDA 204644
BE review for ANDA 204285
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

AUROBINDO PHARMA UNIT IV, INDIA - 483 04/01/2017 - 03/07/2018


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
ZELTIQ AESTHETICS INC - COOLSCULPTING K151179 APRVL RECS
ZELTIQ AESTHETICS INC - COOLSCULPTING K133212 APRVL RECS
ZELTIQ AESTHETICS INC - COOLSCULPTING K162050 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


DR REDDY'S, MEDAK, INDIA - 483 03/01/2018 - 03/10/2018
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
DR REDDY'S, MEDAK, INDIA - 483 03/02/2018 - 03/16/2018
FOIA LOG ABBOTT, ABBOTT LABS, ABBOTT LABORATORIES 12/01/2017 -
02/28/2018
DR REDDY'S, MEDAK, INDIA - 483 03/05/2018 - 03/16/2018
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

AUROBINDO PHARMA UNIT 1, INDIA - 483 03/05/2018 - 03/16/2018


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

AUROBINDO PHARMA UNIT 12, INDIA - 483 03/01/2018 - 03/20/2018


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
Copy of the disclosable portions of all notices of intent
regarding electronic advertising for American Snuff Company,
from 01/01/2009 - present
Copy of the disclosable portions of all notices of intent
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
K171120 REVIEWER'S NOTES
K141077 REVIEWER'S NOTES
K151794 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
ALEMBIC PHARMACEUTICALS, PANELEV, INDIA - 483 01/01/2018 -
03/20/2018
K082898
LEVOLEUCOVORIN FAERS
21ST CENTURY CURES ACT SECTION 3001-3004 RECS PATIENT
EXPERIENCE BLA 01/01/2013 - 03/22/2018
ALEMBIC PHARMACEUTICALS, PANELEV, INDIA - 483 03/01/2018 -
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
ALEMBIC PHARMACEUTICALS, PANELEV, INDIA - 483 01/01/2018 -
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
CANADIAN MEDICAL DEVICE 483 12/10/2008 - 03/27/2018
2017-10016
2018-1399
CANADIAN MEDICAL DEVICE 483 12/15/2008 - 03/27/2018
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 2/19-23/18
DAILY LOG 2/19-23/18
CLOSED LOG 2/26-3/2/18
DAILY LOG 2/26/18-3/2/18
DAILY LOG 2/19-23/18
ARMONAIR RESPICLICK FAERS
DAILY LOG 2/26/18-3/2/18
DAILY LOG 2/19-23/19
DAILY LOG 2/26/18-3/2/18
CLOSED LOG 2/19-23/18
DAILY LOG 2/19-23/18
DAILY LOG 2/26/18-3/2/18
CLOSED LOG 2/26/18-3/2/18
DAILY LOG 2/19-23/18
DAILY LOG 2/26/18-3/2/18
CLOSED LOG 2/19-23/18
AIRDUOTM RESPICLICK FAERS
DAILY LOG 2/19-23/18
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
ANDA 204453 EFFECTIVE APPROVAL LETTER
K162309
MOHAMED A. EL-SHAHAWY, MD, ACADEMIC MEDICAL INSTITUTE, LOS
ANGELES, CA - EIR 02/03/2015 - 03/19/2015
ANDA 208825 TENTATIVE APPROVAL LETTER
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

ALKEM LABORATORIES, DAMAN, INDIA - 483 03/19/2018 - 03/28/2018


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
FOI DAILY LOG 12/4-8/17
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
FOI DAILY LOG 12/4-8/17
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
FOI DAILY LOG 12/4-8/17
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
FOI DAILY LOG 12/4-8/17
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
FOI DAILY LOG 12/4-8/17
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.
8 ANDA approval letters
K171102
FOI DAILY LOG 12/4-8/17
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
FOI DAILY LOG 12/4-8/17

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
FOI DAILY LOG 12/11-15/17
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
FOI DAILY LOG 12/11-15/17
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


FOI DAILY LOG 12/11-15/17
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
FOIA LOG ABBOTT LABORATORIES 03/01/2018 - 03/31/2018
BUREL PHARMACEUTICALS, RICHLAND, MS - EIR 02/22/2018 -
02/23/2018
K900516
HSVI - MEDICINE
FOI DAILY LOG 12/11-15/17
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
FOI DAILY LOG 12/11-15/17
SPREADSHEET OF WARNING LETTERS 10/01/2011 - 03/31/2018
COMMUNICATIONS BETWEEN e5 OR ITS ATTORNEYS AND FDA RE
PHENOBARBITAL 01/01/2014 - 04/02/2018
ANDA 083386 ANDA 084112 ANDA 084113 ETC
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
FOI DAILY LOG 12/11-15/17
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
FOI DAILY LOG 12/11-15/17
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
CLOSED FOI REQUESTS 12/4-8/17

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
CLOSED FOI REQUESTS 12/4-8/17
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
INDIVIDUAL RECS - VAERS
CLOSED FOI REQUESTS 12/4-8/17
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
CLOSED FOI REQUESTS 12/4-8/17
Technical Lead Reports and reviewer notes for the four (4)
Exemption from Substantial Equivalence Final Orders issued in
December 2017
Technical Lead Reports and reviewer notes for the one (1)
Exemption from Substantial Equivalence Final Orders issued in
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
CLOSED FOI REQUESTS 12/11-15/17
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
CLOSED FOI REQUESTS 12/11-15/17
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
CLOSED FOI REQUESTS 12/11-15/17
K131563
BACKGROUND CHECK RECS 10/08/2009 - 10/09/2009
LIST OF INSPECTIONS 02/01/2018 - 03/31/2018
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
CLOSED FOI REQUESTS 12/11-15/17
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
REGISTRATION RECS 03/18/2015 - 08/11/2015

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 -
REGISTRATION RECS 04/28/2015 - 07/18/2016
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, MARRIET