Food and Drug Administration - FOIA Logs - August 2010

Disclosure FOI Request Log Date range from 08/01/2010 to 08/31/2010 Report
Total Records: 908
Control # Recd Date / Action Office Signature/ Requester Subject

Due Date
2010-5781 08/02/2010 OM/OSS/OPILS/DFI/ FOI DAILY LOG 7/19-23/10
08/30/2010 OM/OSS/OPILS/DFI/ CanReg, Inc.
08/30/2010 OM/OSS/OPILS/DFI/ WALTERS KLUWER LAW &
BUSINESS
08/30/2010 OM/OSS/OPILS/DFI/ Center for Regulatory Services, Inc.
2010-5784 08/02/2010 OM/OSS/OPILS/DFI/ FOI DAILY LOG 7/19/23/10
08/30/2010 OM/OSS/OPILS/DFI/ WASHINGTON INFORMATION
SOURCE
08/30/2010 OM/OSS/OPILS/DFI/ KENDLE REGULATORY AFFAIRS
08/30/2010 OM/OSS/OPILS/DFI/ FOI SERVICES INC
2010-5787 08/02/2010 CDRH/OMO/DEMO/FOIB/ BL HEALTHCARE - TCX-I-DV REMOTE CARE
08/30/2010 FOI SERVICES INC MANAGEMENT SYS K093379
2010-5788 08/02/2010 OM/OSS/OPILS/DFI/ 2007-1200

2010-5789 08/02/2010 OM/OSS/OPILS/DFI/ 2010-4560
2010-5790 08/02/2010 CDRH/OMO/DEMO/FOIB/ NEPHROS, INC - DSU DUAL STAGE ULTRAFILTER K090885
08/30/2010 FOI SERVICES INC
2010-5791 08/02/2010 CDRH/OMO/DEMO/FOIB/ NIKKISO CO - DBB-05 HEMODIALYSIS DELIVERY SYS
08/30/2010 FOI SERVICES INC K061519
2010-5792 08/02/2010 CDRH/OMO/DEMO/FOIB/ DAVITA CLINICAL RESEARCH - DBB-05 HEMODIALYSIS

DELIVERY SYS K023509
2010-5793 08/02/2010 CDRH/OMO/DEMO/FOIB/ ROCKWELL MEDICAL TECHNOLOGIES INC - CITRAPURE
K062399
2010-5794 08/02/2010 CDRH/OMO/DEMO/FOIB/ GAMBRO RENAL PRODUCTS - PRISMA SYS K010805
OM/OSS/OPILS/DFI/
2010-5795 08/02/2010 CDRH/OMO/DEMO/FOIB/ GAMBRO RENAL PRODUCTS - PRISMA SYS R03 10A
K062090
2010-5796 08/02/2010 CDRH/OMO/DEMO/FOIB/ GAMBRO - PRISMAFLEX SYS VERSION 3.20 K072093
Page 1 of 65 Thursday September 9 2010 4:28 PM

Total Records: 908

Due Date
2010-5797 08/02/2010 CDRH/OMO/DEMO/FOIB/ B BRAUN MEDICAL - DIAPACT CRRT K973322
2010-5798 08/02/2010 CDRH/OMO/DEMO/FOIB/ B BRAUN MEDICAL - INTROCAN SAFETY IV CATHETER
2010-5799 08/02/2010 CDRH/OMO/DEMO/FOIB/ GAMBRO RENAL PRODUCTS - PRISMASATE DIALYSIS

SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT
THERAPY K072908
2010-5800 08/02/2010 CDRH/OMO/DEMO/FOIB/ HEMAMETRICS - CRIT-LINE MONITOR III TQA K011741
2010-5801 08/02/2010 OM/OSS/OPILS/DFI/ JOAN STITT (UG2DC-16) FOI DAILY LOG 7/19-23/10
08/30/2010 OM/OSS/OPILS/DFI/ MERCK & CO., INC.
2010-5802 08/02/2010 OM/OSS/OPILS/DFI/ LOAN STITT (UG2CD-16) 2010-5276 - REQUEST LTR
2010-5803 08/02/2010 OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) 2010-5318, 2010-5319 REQUEST LTR
2010-5804 08/02/2010 OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) 2010-5390 - REQUEST LTR
2010-5805 08/02/2010 OM/OSS/OPILS/DFI/ SUN - SUATRIPAN SUCCINATI QUALITY CONTROL
PROGRAM FOR DRUGS MADE OUTSIDE OF USA
08/30/2010 OM/OSS/OPILS/DFI/ BRODBECK, TOM
2010-5806 08/02/2010 OM/OSS/OPILS/DFI/ GLENMARK - GABAPENTIN QUALITY CONTROL PROGRAM
FOR DRUGS MADE OUTSIDE OF USA
08/30/2010 OM/OSS/OPILS/DFI/ BRODBECK, TOM
2010-5807 08/02/2010 OM/OSS/OPILS/DFI/ PARK DAVIS - LYRICA QUALITY CONTROL PROGRAM FOR
08/30/2010 OM/OSS/OPILS/DFI/ BRODBECK, TOM DRUGS MADE OUTSIDE USA
2010-5808 08/02/2010 CDRH/OMO/DEMO/FOIB/ SANJIV KUMAR PHOENIX EPIDURAL & SPINAL NEEDLES - K990519
08/30/2010 MYCO MEDICAL
2010-5809 08/02/2010 CDER/ORP/DIDP/ SOMAXON PHARMACEUTICALS INC - SILENOR (DOXEPINE
HCL) NDA 22-036 RVWS, ADMINISTRATIVE RECS
08/30/2010 CDER/ORP/DIDP/ BLUMHARDT, CHRISTINE
2010-5810 08/02/2010 ORA/CE-FO/CHI-DO/CCB/ COLLEEN GRACE DONOFRIO PQ CORP, UTICA, IL - EIRS 2/08, 4/26/10 TO 5/6/10
08/30/2010 BABST CALLAND CLEMENTS ET
AL
2010-5811 08/02/2010 OM/OSS/OPILS/DFI/ MARCIA D HOWARD DRUG LISTING RECS FOR OTC PRODUCTS - UPDATED
08/30/2010 OM/OSS/OPILS/DFI/ CONSUMER HEALTH VERSION
INFORMATION CORPORATION

Total Records: 908

Due Date
2010-5812 08/02/2010 OM/OSS/OPILS/DFI/ PUBLICATIONS HHS-ODPHP-2010-01, 00-4084, 01-3290,
08/30/2010 OM/OSS/OPILS/DFI/ WILLIAMS FDC# E20560, LESTER ETC
OM/OSS/OPILS/DFI/ L
OM/OSS/OPILS/DFI/
2010-5813 08/02/2010 OC/OM/OMP/DDM/ CICELY PARSEGHIAN DKTS FDA-1997-P-0537, FDA-1989-P-0008, FDA-1999-D-
0061, ETC.
08/30/2010 FOLEY HOAG LLP
2010-5814 08/03/2010 CDER/ORP/DIDP/ GRAIG SUVANNAVEJH BIOVAIL CORP - EIRS, 483S, WARNING LTRS ETC 2009-
2010
08/31/2010 CDER/ORP/DIDP/ JEFFERIES & CO
ORA/CE-FO/BLT-DO/CB/
ORA/SE-FO/SJN-DO/SJCB/
2010-5815 08/03/2010 ORA/SW-FO/DEN-DO/COMP/ GRAIG SUVANNAVEJH CEPHALON INC - EIRS, 483S, WARNING LTRS, ETC 2009-
2010
08/31/2010 JEFFERIES & CO
2010-5816 08/03/2010 ORA/CE-FO/PHI-DO/PCB/ GRAIG SUVANNAVEJH ENDO PHARMACEUTICALS - EIRS, 493S, WARNING LTRS
ETC 2009-2010
2010-5817 08/03/2010 ORA/SE-FO/FLA-DO/FCB/ THOMAS WADE YOUNG PAUL W FRANCK, FRANCK'S LAB INC, FRANCK'S
08/31/2010 ORA/OCI/ DEMPSEY & ACCOCIATES PA PHARMACY INC, ETC - INVESTIGATION CORR, RPTS,
WARNING LTR, ETC 4/19/09
2010-5818 08/03/2010 ORA/SW-FO/DAL- ELIZABETH WOECKNER BURZYNSKI RESEARCH INSTITUTE (BRI), HOUSTON, TX -
DO/COMPLIANCE/ EIRS, 483S, & CO RESP12/3-10/08
08/31/2010 CITIZENS FOR RESPONSIBLE
CARE & RESEARCH
2010-5819 08/03/2010 CDER/ORP/DIDP/ VIRGINIA SMITH TAPENTADOL - ISRS 6439998, 6301260, 6314426, ETC
08/31/2010 CDER/ORP/DIDP/ KENDLE REGULATORY AFFAIRS
2010-5820 08/03/2010 CDRH/OMO/DEMO/FOIB/ VIRGINIA SMITH K073515
08/31/2010 KENDLE REGULATORY AFFAIRS
2010-5821 08/03/2010 ORA/NE-FO/NYK-DO/NYDCB/ WALTER E CHALKLEY HI-TECH PHARMACAL, AMITYVILLE, NY - EIRS, 483S, CO
08/31/2010 THOMSON REUTERS RESP 10/21/03 TO 12/09

2010-5823 08/03/2010 CDRH/OMO/DEMO/FOIB/ VIRGINIA SMITH k953076
OM/OSS/OPILS/DFI/
CDRH/OMO/DEMO/FOIB/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/

Total Records: 908

Due Date
2010-5825 08/03/2010 ORA/SE-FO/ATL-DO/ACB/ WALTER E CHALKLEY RIVER'S EDGE PHARMACEUTICALS, SUWANEE, GA - EIRS,
08/31/2010 THOMSON REUTERS 483S, CO RESP 7/13/09 TO 8/12/09

OM/OSS/OPILS/DFI/
2010-5828 08/03/2010 CBER/OCTMA/DDOM/ALFB/ MARY E HANSEN SANOFI PASTEUR, MARCY L'ETOILE, FRANCE - 483S,
08/31/2010 WASHINGTON INFORMATION CORR, CO RESP 3/15/10 TO 4/2/10
SOURCE
2010-5829 08/03/2010 CBER/OCTMA/DDOM/ALFB/ MARY E HANSEN SANOFI PASTEUR, MARCY L'ETOLILE, FRANCE - EIR,
08/31/2010 WASHINGTON INFORMATION CORR, CO RESP 3/15/10 TO 4/2/10
SOURCE
2010-5830 08/03/2010 CDER/ORP/DIDP/ MARY E HANSEN LUPIN LIMITED, MUMBAI, INDIA - 483, CORR, CO RESP
08/31/2010 CDER/ORP/DIDP/ WASHINGTON INFORMATION 5/14/10
SOURCE
2010-5831 08/03/2010 CDER/ORP/DIDP/ MARY E HANSEN LUPIN LIMITED, MUMBAI, INDIA - EIR, CORR, CO RESP
08/31/2010 CDER/ORP/DIDP/ WASHINGTON INFORMATION 5/14/10
SOURCE
2010-5832 08/03/2010 CBER/OCTMA/DDOM/ALFB/ MARY E HANSEN CANGENE CORP, WINNIPEG, CANADA - 483, CORR, CO
08/31/2010 WASHINGTON INFORMATION RESP 4/12-22/10
SOURCE
2010-5833 08/03/2010 CBER/OCTMA/DDOM/ALFB/ MARY E HANSEN CANGENE CORP, WINNIPEG, CANADA - EIR, CORR, CO
08/31/2010 WASHINGTON INFORMATION RESP 4/12-22/10
SOURCE
2010-5834 08/03/2010 ORA/P-FO/SAN-DO/SFCB/ MARY E HANSEN AMPAC FINE CHEMICALS, LLC, RANCH CORDOVA, CA -
483, CORR, CO RESP 2/9-19/10
08/31/2010 WASHINGTON INFORMATION
SOURCE
2010-5835 08/03/2010 ORA/P-FO/SAN-DO/SFCB/ MARY E HANSEN AMPAC FINE CHEMICALS LLC, RANCH CORDOVA, CA - EIR,
CORR, CO RESP 2/9-19/10
SOURCE
2010-5836 08/03/2010 ORA/P-FO/SAN-DO/SFCB/ MARY E HANSEN ABBOTT DIABETES CARE, ALAMEDA, CA - 483. CORR. CO
RESP 3/10
SOURCE

Total Records: 908

Due Date
2010-5837 08/03/2010 ORA/P-FO/SAN-DO/SFCB/ MARY E HANSEN ABBOTT DIABETES CARE, ALAMEDA, CA - EIR, CORR, CO
08/31/2010 WASHINGTON INFORMATION RESP 3/10
SOURCE
2010-5838 08/03/2010 OM/OSS/OPILS/DFI/ FRAN KOCH 2010-4460
08/31/2010 OM/OSS/OPILS/DFI/ INFORMATION ACCESS
2010-5839 08/03/2010 ORA/ORM/ ROBIN GUY GLP INSPS - 483S 2008, 2009
08/31/2010 ROBIN GUY CONSULTING LLC
2010-5840 08/03/2010 ORA/ORM/ CATHERINE LARKIN DRUG MFG PLANTS DATABASE
08/31/2010 BLOOMBERG NEWS
2010-5841 08/03/2010 ORA/ORM/ MARGARET R NAPPI DOMESTIC & FOREIGN INSPS FOR DRUG COMPANIES,
BIORESEARCH MONITORING (BIMO) INSPS 7/1-30/10
08/31/2010 LACHMAN CONSULTANT
SERVICES, INC.
2010-5842 08/03/2010 CFSAN/OCD/EOS/ KRISTI O SMEDLEY PHD KEMIRA OYJ OF FINLAND - FAP 2258
08/31/2010 CVM/OCD/ Center for Regulatory Services, Inc.
CFSAN/OCD/EOS/
2010-5843 08/03/2010 ORA/ORM/ BILL MARTIN GMP INSPS 12/31/09-6/30/10
08/31/2010 ELI LILLY & CO
2010-5844 08/03/2010 CFSAN/OCD/EOS/ LORREN WALKER POM WONDERFUL - CO RESP 3/17/10
08/31/2010 SCHRAMM WILLIAMS &
ASSOCIATES INC
2010-5845 08/03/2010 ORA/P-FO/LOS-DO/LACB/ VIRGINIA SMITH JOHN J MURPHY (SOUTHWESTERN RESEARCH INC),
08/31/2010 KENDLE REGULATORY AFFAIRS BEVERLY HILLS, CA - EIRS, 483S, CO RESP 6/30/05
2010-5846 08/03/2010 ORA/SE-FO/ATL-DO/ACB/ ENTRY #FF1203575-5 - LAB RPT

08/31/2010 DEKO INTERNATIONAL CO LTD
2010-5847 08/03/2010 OM/OMP/DODM/ JACK A KRAMER ESQ DKT 1978N-036L
08/31/2010 TAUBER WESTLAND & BENNETT
PC
2010-5848 08/03/2010 CDER/ORP/DIDP/ HEPARIN - NDC
08/31/2010 CDER/ORP/DIDP/ Doe J
2010-5849 08/03/2010 CDER/ORP/DIDP/ GLIPIZIDE, AMLODIPINE BESYLATE, PROPANOLOL, ETC -
08/31/2010 CDER/ORP/DIDP/ MOSLEY, ALLIE AERS
2010-5850 08/03/2010 CDRH/OMO/DEMO/FOIB/ COLLEEN M DURRAN NEPHROS INC - HEMODIAFILTRATION (HDF) REJECTION
RECS
08/31/2010 FRESENIUS MEDICAL CARE
2010-5851 08/03/2010 OM/OSS/OPILS/DFI/ ROBERT P CHARROW ELI LILLY & CO - CYMBALTA (DULOXETINE) FOIA
REQUESTS

Total Records: 908

Due Date
09/17/2010 OM/OSS/OPILS/DFI/ GREENBERG TRAURIG LLP
2010-5852 08/03/2010 OM/OSS/OPILS/DFI/ CECELIA FRENCH CLOSED FOI REQUESTS 7/26-30/10
2010-5853 08/03/2010 OM/OSS/OPILS/FDAHO/ JEREMY A GREENE MD PHD SCHEIN PHARMACEUTICAL CO - PRODUCTION &
08/31/2010 HARVARD UNIV DEPT OF THE MARKETING OF GENERIC DRUGS 1967 TO 1985
HISTORY OF SCIENCE
2010-5854 08/03/2010 CDRH/OMO/DEMO/FOIB/ JOCELYN KERSTEN K030468
08/31/2010 EKOS CORP
2010-5855 08/03/2010 OM/OSS/OPILS/FDAHO/ JEREMY A GREENE MD PHD MYLAN PHARMACEUTICAL CO - PRODUCTION &
MARKETING OF GENERIC DRUGS 1967 TO 1985
08/31/2010 HARVARD UNIV DEPT OF THE
HISTORY OF SCIENCE
2010-5858 08/03/2010 OM/OSS/OPILS/FDAHO/ JEREMY A GREENE MD PHD BOLAR PHARMACEUTICAL CO - PRODUCTION &
08/31/2010 HARVARD UNIV DEPT OF THE MARKETING OF GENERIC DRUGS 1967 TO 1985
HISTORY OF SCIENCE
2010-5859 08/03/2010 CDER/ORP/DIDP/ PROCTER & GAMBLE MANUFACTURA S DE R L DE CV -
08/31/2010 CDER/ORP/DIDP/ CECENA, TERESA CREST CALCI-DENT MFR REGISTRATION NUMBER
2010-5860 08/03/2010 CDER/ORP/DIDP/ ABBOTT LABORATORIES DE MEXICO S A DE CV -

08/31/2010 CDER/ORP/DIDP/ CECENA, TERESA PEDIALYTE MFR REGISTRATION NUMBER
2010-5861 08/03/2010 CDRH/OMO/DEMO/FOIB/ NICHOLAS JUNGBLUTH W L GORE & ASSOCIATES INC - GORE PRECLUDE VESSEL
GUARD K061727
08/31/2010 OM/OSS/OPILS/DFI/ M SQUARED ASSOCIATES INC
OM/OSS/OPILS/DFI/
2010-5862 08/03/2010 OM/OSS/OPILS/DFI/ ELENA HOWELL 2010-5416
08/31/2010 OM/OSS/OPILS/DFI/ HOGAN LOVELLS US LLP
2010-5863 08/03/2010 CDRH/OMO/DEMO/FOIB/ SRIKANTH K REDDY ESC MEDICAL SYSTEMS LTD - DERMA 20 LASER SYS
08/31/2010 GOODWIN PROCTER LLP K964253
2010-5864 08/03/2010 CDRH/OMO/DEMO/FOIB/ STACIE GEFFNER-ATIYA ENDUIS ATAVI SYS - K022199: METRX SYS - K02931;
KNIGHT ENDOSCOPIC SYSTEM SET - K000046, ETC
08/31/2010 VISION SCIENCES INC
2010-5865 08/03/2010 CDRH/OMO/DEMO/FOIB/ JOSEPH R CARNICELLA CHEK-MED SYSTEMS INC - SPOT ENDOSCOPIC MARKER
08/31/2010 PICADIO SNEATH MILLER ET AL K993951
2010-5866 08/03/2010 CDRH/OMO/DEMO/FOIB/ JOSEPH E KOLAR DEPUY ORTHOPAEDICS - MDR 181890-2009-02141

Total Records: 908

Due Date
08/31/2010 BAIZER & KOLAR PC
2010-5867 08/03/2010 CDER/ORP/DIDP/ NOVARTIS FARMACEUTICIA S A DE C V - LAMISIL CREAM
08/31/2010 CDER/ORP/DIDP/ CECENA, TERESA MFR REGISTRATION NUMBER
2010-5868 08/03/2010 CDER/ORP/DIDP/ SCHERING-PLOUGH S A DE C V - DESENFRIO D MFR

08/31/2010 CDER/ORP/DIDP/ CECENA, TERESA REGISTRATION NUMBER
2010-5869 08/03/2010 CDER/ORP/DIDP/ JOHN DOHERTY IOVATE, HYDROXYCUT, SMARTBURN, ETC - AERS
08/31/2010 CDER/ORP/DIDP/ IOVATE HEALTH SCIENCES
RESEARCH INC
CFSAN/OCD/EOS/
2010-5870 08/03/2010 CDER/ORP/DIDP/ INRE SZENTIPETERI MD DIATOMACEOUS EARTH TABS - RECS
08/31/2010 CDER/ORP/DIDP/ EGIS PHARMACEUTICALS PLC
2010-5871 08/03/2010 OM/OSS/OPILS/DFI/ WALTER E CHALKLEY 2010-3606
08/31/2010 OM/OSS/OPILS/DFI/ THOMSON REUTERS
CDER/ORP/DIDP/
CDER/ORP/DIDP/
2010-5874 08/03/2010 OM/OSS/OPILS/DFI/ GRAIG SUVANNAVEJH PHD MEDICIS PHARMACEUTICAL CORP - EIRS, 483S, CO RESP,
ETC 2009-2010
08/31/2010 OM/OSS/OPILS/DFI/ JEFFERIES & CO
2010-5875 08/03/2010 OM/OSS/OPILS/DFI/ GRAIG SUVANNAVEJH PHD FOREST LABORATORIES INC - EIRS, 483S, CO RESP, ETC
2009-2010
2010-5876 08/03/2010 OM/OSS/OPILS/DFI/ GRAIG SUVANNAVEJH PHD ELAN CORPORATION PLC - EIRS, 483S, CO RESP, ETC
08/31/2010 OM/OSS/OPILS/DFI/ JEFFERIES & CO 2009-2010
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
2010-5877 08/03/2010 OC/OM/OMP/DDM/ BOBBY SCHOCHET DKT 2005-P-0082
08/31/2010 OLSSON FRANK WEEDA
TERMAN BODE MATZ
2010-5878 08/03/2010 OM/OSS/OPILS/DFI/ GRAIG SUVANNAVEJH PHD JAZZ PHARMACEUTICALS INC - EIRS, 483S, CO RESP, ETC
2009-2010
2010-5879 08/03/2010 OM/OSS/OPILS/DFI/ GRAIG SUVANNAVEJH PHD PAR PHARMACEUTICAL CO - EIRS, 483S, CO RESP, ETC
08/31/2010 OM/OSS/OPILS/DFI/ JEFFERIES & CO 2009-2010

Total Records: 908

Due Date
2010-5880 08/03/2010 OM/OSS/OPILS/DFI/ GRAIG SUVANNAVEJH PHD OREXIGEN THERAPEUTICS INC - EIRS, 483S, CO RESP,
08/31/2010 OM/OSS/OPILS/DFI/ JEFFERIES & CO ETC 2009-2010
2010-5881 08/03/2010 OM/OSS/OPILS/DFI/ GRAIG SUVANNAVEJH PHD SOMAXON PHARMS - EIRS, 483S, CO RESP, ETC 2009-2010
2010-5882 08/03/2010 ORA/SE-FO/FLA-DO/FCB/ WALTER E. CHALKLEY JASON POZNER MD, BOCA RATON, FL - EIR, 483, CO RESP
2/12 TO 3/24/10
08/31/2010 THOMSON REUTERS
2010-5883 08/03/2010 ORA/CE-FO/CHI-DO/CCB/ WALTER E. CHALKLEY MEDEFIL INC, GLENDALE HEIGHTS, IL - EIR, 483, CO RESP
12/09 TO 2/10
2010-5884 08/03/2010 ORA/P-FO/SAN-DO/SFCB/ WALTER E. CHALKLEY INDEPENDENT REVIEW CONSULTING, IRB, CORTE
08/31/2010 THOMSON REUTERS MADERA, CA - EIR, 483, CO RESP 2/8-25/10
2010-5885 08/03/2010 ORA/CE-FO/CIN-DO/CCB/ WALTER E. CHALKLEY MEDCENTRAL HEALTH SYS IRB, MANSFIELD, OH - EIR, 483,
CO RESP 3/22-31/10
2010-5886 08/03/2010 ORA/P-FO/SEA-DO/SCB/ WALTER E. CHALKLEY MICROSURGICAL TECHNOLOGY, REDMONT, WA - EIR, 483,
CO RESP 6/3-11/09
2010-5887 08/03/2010 ORA/SW-FO/KAN-DO/COMP/ WALTER E. CHALKLEY PATRICK NEMECHEK, OVERLAND PARK, KS - EIR, 483, CO
08/31/2010 THOMSON REUTERS RESP 2/22/10-3/22/10
2010-5888 08/03/2010 ORA/CE-FO/MIN-DO/MCB/ WALTER E. CHALKLEY NORTH MEMORIAL MEDICAL CTR IRB, ROBBINSDALE, MN -
08/31/2010 THOMSON REUTERS EIR, 483, CO RESP 3/22-30/10
2010-5889 08/03/2010 ORA/NE-FO/NYK-DO/NYDCB/ GRAIG SUVANNAVEJH, PhD WARNER-CHILCOTT - EIR, 483, WARNING LTS, ETC 2009-
2010
08/31/2010 ORA/SE-FO/SJN-DO/SJCB/ JEFFERIES & CO
2010-5890 08/03/2010 ORA/CE-FO/CIN-DO/CCB/ GRAIG SUVANNAVEJH, PhD VANDA PHARMACEUTICALS INC - EIR, 483, WARNING
LTRS, ETC 2009-2010
2010-5891 08/03/2010 ORA/CE-FO/CIN-DO/CCB/ GRAIG SUVANNAVEJH, PhD VALEANT PHARMACEUTICALS INTERNATIONAL - EIR, 483,
08/31/2010 JEFFERIES & CO WARNING LTRS, ETC 2009-2010
2010-5892 08/03/2010 ORA/P-FO/LOS-DO/LACB/ GRAIG SUVANNAVEJH, PhD ALLERGAN INC - EIR, 483, WARNING LTS, ETC 2009-2010
09/07/2010 ORA/P-FO/SAN-DO/SFCB/ JEFFERIES & CO
ORA/SW-FO/DAL-
DO/COMPLIANCE/
2010-5893 08/03/2010 CDER/ORP/DIDP/ GRAIG SUVANNAVEJH, PhD PATHEON INC - EIR, 483, WARNING LTRS, ETC 2009-2010
ORA/CE-FO/CIN-DO/CCB/
ORA/P-FO/SEA-DO/SCB/

Total Records: 908

Due Date
2010-5894 08/03/2010 CDER/ORP/DIDP/ GRAIG SUVANNAVEJH, PhD SANDOZ - EIR, 483, WARNING LTRS, ETC 2009-2010
ORA/CE-FO/NJ-DO/NJCB/
ORA/NE-FO/NYK-DO/NYDCB/
ORA/SE-FO/ATL-DO/ACB/
ORA/SW-FO/DEN-DO/COMP/
ORA/SW-FO/KAN-DO/COMP/
2010-5895 08/03/2010 ORA/SE-FO/FLA-DO/FCB/ GRAIG SUVANNAVEJH, PhD SALIX PHARMACEUTICALS INC - EIR, 483, WARNING LTRS,
08/31/2010 JEFFERIES & CO ETC 2009-2010
2010-5896 08/03/2010 ORA/SE-FO/FLA-DO/FCB/ GRAIG SUVANNAVEJH, PhD MYLAN INC - EIR, 483, WARNING LTS, ETC 2009-2010
08/31/2010 ORA/CE-FO/BLT-DO/CB/ JEFFERIES & CO
ORA/NE-FO/NWE-DO/NWECB/
ORA/SW-FO/DAL-
DO/COMPLIANCE/
2010-5897 08/03/2010 ORA/P-FO/SAN-DO/SFCB/ GRAIG SUVANNAVEJH, PhD IMPAX LABORATORIES INC - EIR, 483, WARNING LTS, ETC
2009-2010
2010-5898 08/03/2010 ORA/CE-FO/BLT-DO/CB/ GRAIG SUVANNAVEJH, PhD WATSON PHARMACEUTICALS INC - EIR, 483, WARNING
08/31/2010 ORA/CE-FO/CHI-DO/CCB/ JEFFERIES & CO LTS, ETC 2009-2010
ORA/CE-FO/MIN-DO/MCB/
ORA/CE-FO/PHI-DO/PCB/
ORA/P-FO/LOS-DO/LACB/
ORA/P-FO/SAN-DO/SFCB/
ORA/SE-FO/FLA-DO/FCB/
ORA/SW-FO/DAL-
DO/COMPLIANCE/
2010-5899 08/03/2010 ORA/CE-FO/BLT-DO/CB/ GRAIG SUVANNAVEJH, PhD TEVA PHARMACEUTICAL INDUSTRIES LTD - EIR, 483,
08/31/2010 ORA/CE-FO/MIN-DO/MCB/ JEFFERIES & CO WARNING LTS, ETC 2009-2010

Total Records: 908

Due Date
2010-5900 08/04/2010 CDER/ORP/DIDP/ RISK-BASED MODEL FOR PRIORITISING CGMP
09/01/2010 CDER/ORP/DIDP/ GEYMAN, CATHERINE INSPECTIONS OF PHARMACEUTICAL MANUFACTURING
SITES - A PILOT RISK RANKING MODEL 9/04
2010-5901 08/04/2010 CDER/ORP/DIDP/ MICHELE R HALL PROFESSIONAL DISPOSABLES INC, NICE-PAK PRODUCTS
INC - CHLORA SCRUB CORR, RECS 2004 TO PRESENT
09/01/2010 CDER/ORP/DIDP/ SONNENSCHEIN NATH &
ORA/NE-FO/NYK-DO/NYDCB/ ROSENTHAL LLP
2010-5902 08/04/2010 CVM/OCD/ GERALDINE E EDENS COMPANIES THAT PRODUCE OR USE ANTI-SEALING
09/01/2010 MCKENNA LONG & ALDRIDGE AGENTS FOR THE PRODUCTION OF ANIMAL FEED - LTRS,
LLP RECS
2010-5903 08/04/2010 CTP/OD/ J BENNEVILLE HAAS ESQ SMALL MANUFACTURERS ASSOCIATION FOR THE
09/01/2010 CTP/OD/ LATHAM & WATKINS LLP REASONABLE TREATMENT OF TOBACCO (SMARTT)
COALITION - MTG MINS 6/30/10
2010-5904 08/04/2010 CDER/ORP/DIDP/ DEBORAH GOFF RLD (TRANDATE) NDA 18-716 - LBLG
09/01/2010 CDER/ORP/DIDP/ SANDOZ INC
2010-5905 08/04/2010 CDER/ORP/DIDP/ PAMELA A JACOBSON ZYDUS PHARMS USA INC - MYCOPHENOLATE MOFETIL
09/01/2010 CDER/ORP/DIDP/ UNIV OF MINNESOTA COLLEGE NDA 65-433, NDA 65-477 BIOEQV STUDY
OF PHARMACY
2010-5906 08/04/2010 CDER/ORP/DIDP/ BLESSY JOHNS VANCOCIN HCL CAPS NDA 50-606 - APRVL RECS
09/01/2010 CDER/ORP/DIDP/ AUROLIFE PHARMA LLC
2010-5907 08/04/2010 CDER/ORP/DIDP/ KAREN G KELSEN OPTIRAY IOVERSOL INJ - AERS
09/01/2010 CDER/ORP/DIDP/ MAZIE SLATER KATZ ET AL
2010-5908 08/04/2010 ORA/SE-FO/ATL-DO/ACB/ CMPLNT #115486
09/01/2010 KING, CLARICE
2010-5909 08/04/2010 ORA/CE-FO/BLT-DO/CB/ CMPLNT #115330
09/01/2010 MALKIN, KAREN A
2010-5910 08/04/2010 CDRH/OMO/DEMO/FOIB/ ROBERT WAGNER GENTLEWAVES CONSUMER LED PHOTOMODULATION -
09/01/2010 OM/OSS/OPILS/DFI/ AEGIS REGULATORY INC K062991
OM/OSS/OPILS/DFI/
2010-5911 08/04/2010 CDRH/OMO/DEMO/FOIB/ ROBERT WAGNER STAR-LITE LM MODEL SI8809 - K092460
09/01/2010 AEGIS REGULATORY INC
2010-5912 08/04/2010 CDRH/OMO/DEMO/FOIB/ ROBERT WAGNER OMNILUX NEW-U - K072459
09/01/2010 OM/OSS/OPILS/DFI/ AEGIS REGULATORY INC

Total Records: 908

Due Date
OM/OSS/OPILS/DFI/
2010-5913 08/04/2010 OM/OSS/OPILS/DFI/ MARK P BAYER SPL RECS
09/01/2010 OM/OSS/OPILS/DFI/ REED TECHNOLOGY AND
OM/OSS/OPILS/DFI/ INFORMATION SERVICES INC
OM/OSS/OPILS/DFI/
2010-5914 08/04/2010 CDER/ORP/DIDP/ LAURIE C STEELE MYOVIEW NDA 20-372 - FOI REQUESTS 1/07 TO PRESENT
09/01/2010 CDER/ORP/DIDP/ REED SMITH LLP
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
2010-5915 08/04/2010 OM/OSS/OPILS/DFI/ CLOSED FOI REQUESTS 7/26/10-8/1/10
2010-5916 08/04/2010 ORA/P-FO/SAN-DO/SFCB/ ANGELIA D SLAYTON FRANCIS PIEN (INTERNAL MEDICINE & INFECTIOUS
DISEASES), HONOLULU, HI - EIR, 483, CO RESP 1/25/10
2010-5917 08/04/2010 ORA/SE-FO/SJN-DO/SJCB/ ANGELIA D SLAYTON ORTHO MCNEIL-JANSSEN PHARMACEUTICALS INC, SAN
GERMAN, PR - EIR, 483, CO RESP 6/8/09
2010-5918 08/04/2010 CBER/OCTMA/DDOM/ALFB/ JOAN STITT (UG2CD-16) MERCK & CO INC - PROQUAD (MEASLES, MUMPS,
09/01/2010 MERCK & CO., INC. RUBELLA & VARICELLA VIRUS VACCINE) VAERS 7/1-31/10
2010-5919 08/04/2010 CBER/OCTMA/DDOM/ALFB/ JOAN STITT (UG2CD-16) MERCK & CO INC - ROTATEQ (ROTAVIRUS VACCINE)
VAERS 7/1-31/10
09/01/2010 MERCK & CO., INC.
2010-5920 08/04/2010 CBER/OCTMA/DDOM/ALFB/ JOAN STITT (UG2CD-16) MERCK & CO INC - GARDASIL (HPV VACCINE) VAERS 7/1-
31/10
09/01/2010 MERCK & CO., INC.
2010-5921 08/04/2010 CDER/ORP/DIDP/ JOAN STITT (UG2CD-16) MERCK & CO INC - ISENTRESS (RALTEGRAVIR) VAERS 7/1-
09/01/2010 CDER/ORP/DIDP/ MERCK & CO., INC. 31/10
2010-5922 08/04/2010 OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) FOI DAILY LOG 7/26-30/10
2010-5923 08/04/2010 OM/OSS/OPILS/DFI/ JOAN STITT (UG2CD-16) CLOSED FOI REQUESTS 7/1-31/10
2010-5924 08/04/2010 ORA/P-FO/LOS-DO/LACB/ VIRGINIA SMITH DR JELENA KUNOVAC (EXCELL RESEARCH), OCEANSIDE,
CA - EIR, 483, CO RESP 4/21/08
2010-5925 08/04/2010 ORA/P-FO/LOS-DO/LACB/ SHERMAN L. MAH ENTRY # 22119274458
09/01/2010 CERTIFIED LABORATORIES INC
2010-5926 08/04/2010 CDER/ORP/DIDP/ PAMELA A. JACOBSON TEVA - MYCOPHENOLATE MOFETIL ANDA 65-491, ANDA
65-457 BIOEQV STUDY
09/01/2010 CDER/ORP/DIDP/ UNIV OF MINNESOTA COLLEGE

Total Records: 908

Due Date
OF PHARMACY
2010-5927 08/04/2010 CDER/ORP/DIDP/ PAMELA A. JACOBSON STRIDES ARCOLAB LTD - MYCOPHENOLATE MOFETIL
09/01/2010 CDER/ORP/DIDP/ UNIV OF MINNESOTA COLLEGE ANDA 90-055, ANDA 90-456 BIOEQV STUDY
OF PHARMACY
2010-5928 08/04/2010 CDER/ORP/DIDP/ PAMELA A. JACOBSON SANDOZ - MYCOPHENOLATE MOFETIL ANDA 65-379, ANDA
09/01/2010 CDER/ORP/DIDP/ UNIV OF MINNESOTA COLLEGE 65-451 BIOEQV STUDY
OF PHARMACY
2010-5929 08/04/2010 CDER/ORP/DIDP/ PAMELA A. JACOBSON ROXANE - MYCOPHENOLATE MOFETIL ANDA 65-410,
09/01/2010 CDER/ORP/DIDP/ UNIV OF MINNESOTA COLLEGE ANDA 65-413 BIOEQV STUDY
OF PHARMACY
2010-5930 08/04/2010 CDER/ORP/DIDP/ PAMELA A. JACOBSON MYLAN - MYCOPHENOLATE MOFETIL ANDA 65-520, ANDA
09/01/2010 CDER/ORP/DIDP/ UNIVERSITY OF MINNESOTA 65-521 BIOEQV STUDY
2010-5931 08/04/2010 CDER/ORP/DIDP/ PAMELA A. JACOBSON ENDO PHARMS - MYCOPHENOLATE MOFETIL ANDA 90-
09/01/2010 CDER/ORP/DIDP/ UNIVERSITY OF MINNESOTA 111, ANDA 90-606 BIOEQV STUDY
2010-5932 08/04/2010 CDER/ORP/DIDP/ PAMELA A. JACOBSON APOTEX - MYCOPHENOLATE MOFETIL ANDA 90-419, ANDA
90-499 BIOEQV STUDY
09/01/2010 CDER/ORP/DIDP/ UNIVERSITY OF MINNESOTA
2010-5933 08/04/2010 CDER/ORP/DIDP/ PAMELA A. JACOBSON ACCORD HLTHCARE - MYCOPHENOLATE MOFETIL ANDA
90-402, ANDA 65-416 BIOEQV STUDY
2010-5934 08/04/2010 CDER/ORP/DIDP/ PAMELA A. JACOBSON TACROLIMUS ANDA 90-402 - BIOEQV STUDY
2010-5935 08/04/2010 CDER/ORP/DIDP/ PAMELA A. JACOBSON TACROLIMUS ANDA 65-461 - BIOEQV STUDY
2010-5936 08/05/2010 OM/OSS/OPILS/DFI/ WARNING LTRS 8/310
09/02/2010 OM/OSS/OPILS/DFI/ Hyman, Phelps & McNamara, P.C.
2010-5937 08/05/2010 CDER/ORP/DIDP/ DR REDDYS LABS, HYDERABAD, INDIA - EIRS, 483S 1/03 TO
09/02/2010 CDER/ORP/DIDP/ FOI SERVICES INC PRESENT
2010-5938 08/05/2010 CDER/ORP/DIDP/ MERZ PHARMS - NAFTIN CREAM NDA 19-5992/S001,002

09/02/2010 CDER/ORP/DIDP/ FOI SERVICES INC APRVL RECS
2010-5939 08/05/2010 CDER/ORP/DIDP/ MERS PHARMS - NAFTIN GEL N-19-356 APRVL RECS
09/02/2010 CDER/ORP/DIDP/ FOI SERVICES INC
2010-5940 08/05/2010 CFSAN/OCD/EOS/ KELLOGG - CEREAL RECALL 6/10
09/02/2010 ORA/CE-FO/DET-DO/DCB/ Doe J
2010-5941 08/05/2010 CDER/ORP/DIDP/ SANDOZ - ENOXAPARIN SODIUM ANDA 77-857 APRVL
09/02/2010 CDER/ORP/DIDP/ FOI SERVICES INC RECS

Total Records: 908

Due Date
2010-5942 08/05/2010 CFSAN/OCD/EOS/ POM WONDERFUL - POMEGRANATE JUICE RESP TO
09/02/2010 FOI SERVICES INC WARNING LTR CORR, MEMOS, MINS, ETC 2/23/10
2010-5943 08/05/2010 CBER/OCTMA/DDOM/ALFB/ HEMOLYTIC TRANSFUSION - RPT

09/02/2010 Doe J
2010-5944 08/05/2010 CFSAN/OCD/EOS/ BAYER MATERIAL SCIENCE AG - FCN 695
2010-5945 08/05/2010 CDRH/OMO/DEMO/FOIB/ LISA PETERSON MEDAPPS 2.0 - K083862
09/02/2010 QA CONSULTING INC
2010-5946 08/05/2010 ORA/ APRIL HOLLIS KLINGE CHEMICALS LTD, GLASGOW, GB - 483S 6/1-30/10
09/02/2010 CDER/ORP/DIDP/ FDA NEWS
CDER/ORP/DIDP/
2010-5947 08/05/2010 CDER/ORP/DIDP/ APRIL HOLLIS CILAG AG, SCHAFFHAUSEN, CH, TAIWAN
FUJIMOTOCHEMICAL, MIAOLI, TW, LONZA AG, VISP, CH,
ETC - 483S 6/1-30/10
2010-5948 08/05/2010 ORA/ORM/ APRIL HOLLIS LIST OF BIOLOGICS & MEDICAL DVC MFG FACILITIES IN
09/02/2010 FDA NEWS THE USA & OUTSIDE THE USA 7/1-30/10
2010-5949 08/05/2010 ORA/SE-FO/ATL-DO/ACB/ APRIL HOLLIS HOSPIRA, ROCKY MOUNT, NC - 483S 6/1-30/10
09/02/2010 FDA NEWS
2010-5950 08/05/2010 ORA/CE-FO/BLT-DO/CB/ APRIL HOLLIS NOXELL CORP, HUNT VALLEY, MD; RHODIA, BALTIMORE,
MD; EASTERN CRANIAL AFFILIATES, ARLINGTON, VA, ETC -
09/02/2010 FDA NEWS
483S 6/1-30/10
2010-5951 08/05/2010 ORA/CE-FO/CIN-DO/CCB/ APRIL HOLLIS BIONIX DEVELOPMENT CORP, TOLEDO, OH - 483S 6/1-
09/02/2010 FDA NEWS 30/10
2010-5952 08/05/2010 ORA/CE-FO/PHI-DO/PCB/ APRIL HOLLIS MEDIMMUNE, MEDICAL PRODUCTS LABS, PHILADELPHIA,
09/02/2010 FDA NEWS PA; SPRAY-TEK, BETHLEHEM, PA, ETC - 483S 6/1-30/10
2010-5953 08/05/2010 ORA/CE-FO/CHI-DO/CCB/ APRIL HOLLIS ANCHOR PRODUCTS CO, ADDISON IL; OHIO MEDICAL
CORP, GURNEE, IL - 483S 6/1-30/10
09/02/2010 FDA NEWS
2010-5954 08/05/2010 ORA/SW-FO/DAL- APRIL HOLLIS ISO-TEX DIAGNOSTICS, FRIENDSWOOD, TX; MEDRO
DO/COMPLIANCE/ SYSTEMS, MCKINNEY, TX, DIVERSIFIED DIAGNOSTIC
09/02/2010 FDA NEWS
PRODUCTS, HOUSTON, TX, ETC - 483S 6/1-30/10
2010-5955 08/05/2010 ORA/P-FO/SEA-DO/SCB/ APRIL HOLLIS HOLLISTER STIER LABS, SPOKANE, WA; PARKS MEDICAL
09/02/2010 FDA NEWS ELECTRONICS, ALOHA OR; VERATHON, BOTHELL, WA -
483S 6/1-30/10
2010-5956 08/05/2010 ORA/SW-FO/DEN-DO/COMP/ APRIL HOLLIS REGENERATIVE SCIENCES, BROOMFIELD, CO, AMERICAN
BIOTECH LABS, ALPINE, UT - 483S 6/1-30/10
09/02/2010 FDA NEWS
2010-5957 08/05/2010 ORA/CE-FO/DET-DO/DCB/ APRIL HOLLIS SIGMA-TAU PHARMASOURCE, INDIANAPOLIS, IN; JARDON

Total Records: 908

Due Date
09/02/2010 FDA NEWS EYE PROSTHETICS, SOUTHFIELD, MI; GUNNELL,
MILLINGTON, MI - 483S 6/1-30/10
2010-5958 08/05/2010 ORA/SE-FO/FLA-DO/FCB/ APRILL HOLLIS ALL MED SERVICES OF FLORIDA, TAMPA, FL; WINCO,
OCALA, FL; CARE TECH INDUSTRIES, SEMINOLE, FL, ETC -
09/02/2010 FDA NEWS
483S 6/1-30/10
2010-5959 08/05/2010 ORA/SE-FO/SJN-DO/SJCB/ APRIL HOLLIS BRISTOL MYERS SQUIBB, HUMACAO, PR; ORTHO
09/02/2010 FDA NEWS BIOLOGICS, MANATI, PR; ST JUDE MEDICAL, ARECIBO, PR,
ETC - 483S 6/1-30/10
2010-5960 08/05/2010 CDRH/OMO/DEMO/FOIB/ JON BROCKMAN CEREC OPTI SPRAY - K080882
09/02/2010 IOS TECHNOLOGIES INC
2010-5961 08/05/2010 ORA/P-FO/SAN-DO/SFCB/ APRIL HOLLIS VITALWEAR, SOUTH SAN FRANCISCO, CA; BIOCHECK,
09/02/2010 FDA NEWS FOSTER CITY, CA; TERARECON, SAN MATEO, CA, ETC -
483S 6/1-30/10
2010-5962 08/05/2010 CDRH/OMO/DEMO/FOIB/ CLAUDE BERTHOIN DEXIS SOFTWARE - K090431
09/02/2010 DENTERPRISE
2010-5963 08/05/2010 ORA/CE-FO/MIN-DO/MCB/ APRIL HOLLIS DAKOTA LABS, MITCHELL, SD; MINNTECH
CORP,PLYMOUTH, MN; XTEN INDUSTRIES,KENOSHA, WI,
09/02/2010 FDA NEWS
ETC - 483S 6/1-30/10
2010-5964 08/05/2010 CDER/ORP/DIDP/ RICHARD YOUNGSTROM AXELLIA PHARMACEUTICALS APS (ALPHARMA SPS),
09/02/2010 CDER/ORP/DIDP/ NYCOMED US INC COPENHAGEN, DENMARK - EIRS 5/2-6/05
2010-5965 08/05/2010 CDER/ORP/DIDP/ RICHARD YOUNGSTROM AXELLIA PHARMACEUTICALS APS, OSLO, NORWAY - EIRS
09/02/2010 CDER/ORP/DIDP/ NYCOMED US INC 6/16-23/08
2010-5966 08/05/2010 CDER/ORP/DIDP/ ELLIOT ISRAEL MD TIOTROPIUM - IND 101,608 RECS

09/02/2010 CDER/ORP/DIDP/ HARVARD MEDICAL SCHOOL
2010-5967 08/05/2010 CDER/ORP/DIDP/ SARAH M FRAZIER NOVO NORDISK A/S, NORDISK, INC - VICTOZA SUPPL
09/02/2010 CDER/ORP/DIDP/ BERG & ANDROPHY DRUG APPL, APRVL, RVWS, ETC
2010-5968 08/05/2010 CDER/ORP/DIDP/ ADEZA BIOMEDICAL - GESTIVA 17 ALPHA-

09/02/2010 CDER/ORP/DIDP/ AUGUSTINE, MARK E HYDROXPROGESTERONE CAPROATE INJ NDA 21-945
APPROVABLE LTR 10/06, RESP LTR 1/09, ETC
2010-5969 08/05/2010 ORA/NE-FO/NWE-DO/NWECB/ LAURA PANK VIACELL INC, CAMBRIDGE, MA; VIACORD (A PERKIN ELMER
CO); VIACORD PROCESSING LABORATORY, HEBRON, KY -
09/02/2010 ORA/CE-FO/CIN-DO/CCB/ CBR SYSTEMS INC
EIRS, 483S 1/07 TO 12/09
2010-5970 08/05/2010 ORA/NE-FO/NYK-DO/NYDCB/ APRIL HOLLIS FISCHER WALLACE LABS, NEW YORK, NY - 483S 6/1-30/10
09/02/2010 FDA NEWS
2010-5971 08/05/2010 ORA/CE-FO/CIN-DO/CCB/ RACHAEL Y PILEGGI P&G PET FOOD PLANT, LEWISBURG, OH - EIRS,
ANALYTICAL TEST, SPLS, ETC 5/21/10, 7/7--8/10
09/02/2010 P&G
2010-5972 08/05/2010 ORA/SE-FO/NOL-DO/NOCB/ APRIL HOLLIS GC HANFORD MFG, SYRACUSE, NY; QUADRISCISER, KT

Total Records: 908

Due Date
09/02/2010 FDA NEWS MEDICAL, KNOXVILLE, TN, ETC - 483S 6/1-30/10
2010-5973 08/05/2010 OM/OSS/OPILS/DFI/ STEVE BONIN MEDTOX LABORATORIES INC - EIRS 4/5-9/10
09/02/2010 OM/OSS/OPILS/DFI/ MEDTOX LABORATORIES INC
2010-5974 08/05/2010 ORA/CE-FO/NJ-DO/NJCB/ APRIL HOLLIS RUTHERFORD CHEMICALS, BAYONNE, NJ; ACTAVIS
09/02/2010 FDA NEWS ELIZABETH, ELIZABETH, NJ; TRI-MED LABS, SOMERSET,
NJ, ETC - 483S 6/1-30/10
2010-5975 08/05/2010 ORA/NE-FO/NWE-DO/NWECB/ APRIL HOLLIS PCI SYNTHESIS, NEWBURYPORT, MA; PROMETHEUS
GROUP, DOVER, NH; ONCO LAB, BOSTON, MA, ETC - 483S
09/02/2010 FDA NEWS
6/1-30/10
2010-5976 08/05/2010 ORA/P-FO/LOS-DO/LACB/ APRIL HOLLIS MCGRUFF PHARMS, SANTA ANA, CA; FNC MEDICAL CORP,
09/02/2010 FDA NEWS VENTURA, CA; BOIRON, SIMI VALLEY, CA, ETC - 483S 6/1-
30/10
2010-5977 08/05/2010 ORA/SW-FO/KAN-DO/COMP/ APRIL HOLLIS HEALTHCARE EQUIPMENT & SUPPLY, PERRYVILLE, MO;
HOME MEDICAL SUPPLY, POPLAR BLUFF, MO; BAYER
09/02/2010 FDA NEWS
HEALTH CARE, SHAWNEE, KS, ETC - 483S 6/1-30/10
2010-5978 08/05/2010 CDRH/OMO/DEMO/FOIB/ APRIL HOLLIS OPTILASA SA, MADRID, ES; BIOTECH INTERNATIONAL,
09/02/2010 FDA NEWS SALON DE PROVENCE; HEALTH AND LIFE, CHUNG HO
CITY, TW, ETC - 483S 6/1-30/10
2010-5979 08/05/2010 CDRH/OMO/DEMO/FOIB/ DIONNE SANDERS DEPUY ORTHOPAEDICS INC - COMPARTMENTAL KNEE
PROSTHESIS SYS K061648
09/02/2010 MAKO SURGICAL CORP
2010-5980 08/05/2010 CDRH/OMO/DEMO/FOIB/ DIONNE SANDERS DEPUY ORTHOPAEDICS INC - DEPUY GCK FEMORAL AND
TIBIAL COMPONENTS K070849
2010-5981 08/05/2010 CDRH/OMO/DEMO/FOIB/ DIONNE SANDERS DEPUY ORTHOPAEDICS INC - SIGMA HIGH PERFORMACE
09/02/2010 MAKO SURGICAL CORP UNITY KNEE RESURFACING SYS K070267
2010-5982 08/05/2010 CDRH/OMO/DEMO/FOIB/ DIONNE SANDERS INTEGRATED SURGICAL SYSTEMS INC - DIGIMATCH
ROBODOC SURGICAL SYS K072629
2010-5983 08/05/2010 CDRH/OMO/DEMO/FOIB/ DIONNE SANDERS HOWMEDICA OSTEONICS CORP - STYKER
COMPARTMENTAL KNEE SYS K052917
2010-5984 08/05/2010 CDRH/OMO/DEMO/FOIB/ DIONNE SANDERS BIOMET MANUFACTURING CORP - VITAMIN E
09/02/2010 MAKO SURGICAL CORP ACETABULAR LINERS (E-POLY) K050327
2010-5985 08/05/2010 CDRH/OMO/DEMO/FOIB/ DIONNE SANDERS BIOMET MANUFACTURING CORP - VITAMIN E

09/02/2010 MAKO SURGICAL CORP POLYETHYLENE TIBIAL BEARINGS K080528
2010-5986 08/05/2010 CFSAN/OCD/EOS/ STUART H SMITH GULF COAST OIL SPILL - PUBLIC HEALTH HAZARD RECS
09/02/2010 OC/OM/OSS/OAGS/ SMITH STAG LLC
ORA/
OC/OCM/EMOPS/

Total Records: 908

Due Date
OC/COS/OES/
OC/COS/OES/
ORA/
ORA/ORO/
ORA/CE-FO/CIN-DO/CCB/
ORA/SE-FO/NOL-DO/NOCB/
ORA/SW-FO/DAL-
DO/COMPLIANCE/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
OC/OM/OEO/
2010-5987 08/05/2010 ORA/SW-FO/DAL- WILLIAM M SLAUGHTER II SPL 634801, 625867, 625869 - ANALYTICAL RESULTS
DO/COMPLIANCE/ TEJAS INDUSTRIES
09/02/2010
2010-5988 08/05/2010 CDRH/OMO/DEMO/FOIB/ SYNTEX DENTAL PRODUCTS - STERILE WATER SYS
K823230
2010-5989 08/05/2010 CDRH/OMO/DEMO/FOIB/ BOSTON SCIENTIFIC - WALLFLEX BILIARY RX PARTIALLY
FOI SERVICES INC COVERED STENT SYS K083374
09/02/2010
2010-5990 08/05/2010 CDRH/OMO/DEMO/FOIB/ WEIGAO, SHANDONG PROVICE, CHINA - EIRS. 483S 2002
FOI SERVICES INC TO PRESENT
09/02/2010
2010-5991 08/05/2010 CDRH/OMO/DEMO/FOIB/ BOSTON SCIENTIFIC - WALLFLEX BILIARY RX FULLY
COVERED STENT SYS K083627
2010-5992 08/05/2010 OC/OM/OMP/DDM/ ROMAINE BARR DKT FDA-2010-D-0277
09/02/2010 ARNOLD & PORTER
2010-5993 08/06/2010 CDRH/OMO/DEMO/FOIB/ ARTHUR J WARD NAVITRACK SYS-OS KNEE UNIVERSAL MODEL PRO-05002
REGULATORY & MARKETING - K060335
09/03/2010
SERVICES INC
2010-5994 08/06/2010 CDRH/OMO/DEMO/FOIB/ NICK LEWIS DIEGENE CORP, GAITHERSBURG, MD - HYBRID CAPTURE
ROCHE MOLECULAR SYSTEMS 2 HIGH-RISK HPV DNA TEST P890064/S014 RECS
09/03/2010
2010-5995 08/06/2010 CDRH/OMO/DEMO/FOIB/ SAMANTHA AUTREY K953414, K951483, K980066, ETC
09/03/2010 MICROTEK MEDICAL INC
2010-5996 08/06/2010 CDRH/OMO/DEMO/FOIB/ SAMUEL F COIN MD BECKMAN COULTER - ACCU TNI TEST KIT COMM 1/1/09 TO

Total Records: 908

Due Date
09/03/2010 FIRST MANHATTAN CO 8/4/10
2010-5997 08/06/2010 CDRH/OMO/DEMO/FOIB/ DIONNE SANDERS STRYKER ORTHOPAEDICS, MAHWAH, NJ - TOTAL KNEE
09/03/2010 MAKO SURGICAL CORP JOINT REPLACEMENT PROSTHESIS K072575
2010-5998 08/06/2010 CDER/ORP/DIDP/ MARY L GEISSLER BAYER HEALTHCARE - NEXAVAR (SORAFENIB TOSYLATE)
09/03/2010 CDER/ORP/DIDP/ Alnylam Pharmaceuticals NDA 21-923 RVWS, ADMINISTRATIVE RECS, APRVL
2010-5999 08/06/2010 CDER/ORP/DIDP/ MARSH RICKARD BRYAN SLATE PHARMACEUTICALS - RESP TO WARNING LTR
3/23/10
09/03/2010 CDER/ORP/DIDP/ MARSH RICKARD & BRYAN PC
2010-6000 08/06/2010 CDER/ORP/DIDP/ ROSE RELVO CERTOLUZIMAB PERGOL - SUPPLEMENTAL APRVL 5/09
09/03/2010 CDER/ORP/DIDP/ OREGON HEALTH SCIENCE
UNIVERSITY
2010-6001 08/06/2010 ORA/SW-FO/DEN-DO/COMP/ PAUL W TRIPP HOT SPRINGS COUNTY MEMORIAL HOSPITAL, WYOMING -
09/03/2010 ORA/SW-FO/DAL- LINCARE INC EIRS, 483S, WARNING LTRS 1/03 TO PRESENT
DO/COMPLIANCE/
2010-6002 08/06/2010 ORA/SW-FO/DEN-DO/COMP/ PATTI WALLER ROCKY MOUNTAIN NATURAL MEATS E COLI OUTBREAK -
EMAILS, INVESTIGATIONS, LAB TEST RESULTS, ETC 6/10
09/03/2010 MARLER CLARK ATTYS
2010-6003 08/06/2010 ORA/CE-FO/BLT-DO/CB/ MARCY B JACK BEEBE MEDICAL CENTER, LEWES, DE - HEPARIN MEMO
09/03/2010 OM/OSS/OPILS/DFI/ BEEBE MEDICAL CENTER OF INVESTIGATION
OM/OSS/OPILS/DFI/
2010-6004 08/06/2010 ORA/CE-FO/PHI-DO/PCB/ GIANT EAGLE INC - CHICKEN OF THE SEA RECALL FORMS
6/30/10
09/03/2010 Giant Eagle
2010-6005 08/06/2010 ORA/CE-FO/NJ-DO/NJCB/ PATTY HOOGENDAM MALLINCKRODT BAKER, PHILLIPSBURG, NJ - AUDIT
09/03/2010 TRILLIUM HEALTH CARE SUMMARY 8/14-15/09
PRODUCTS INC
2010-6006 08/06/2010 ORA/P-FO/SAN-DO/SFCB/ JEFF STACHEWICZ ACCURAY, SUNNYVALE, CA - EIR 2/06, 3/06
09/03/2010 FOIA GROUP INC
2010-6007 08/06/2010 ORA/NE-FO/NYK-DO/NYDCB/ STEVE WAGNER KREITCHMAN PET CENTER - INVESTIGATIONS, RPTS,
09/03/2010 CITIZENS COMMISSION ON FINDINGS 2004, 2008, 2010
HUMAN RIGHTS INTERNATIONAL
2010-6008 08/06/2010 ORA/NE-FO/NYK-DO/NYDCB/ CHRISTINE M LOCKETTE DR MIRACLE'S LLC, NEW YORK, NY - HOT GRO HAIR &
09/03/2010 CHRISSYS INTERIOR DESIGN SCALP CONDITIONER (FEEL IT FORMULA) EIRS, 483S,
CMPLNTS, ETC 1/08 TO PRESENT
2010-6009 08/06/2010 OM/OMP/DODM/ STUART A DAVIDSON DKT 1975N-0017
09/03/2010 ROBBINS GELLER ET AL
2010-6010 08/06/2010 CFSAN/OCD/EOS/ MARY MCGUIRE STYRENE-ACRYLONITRILE COPOLYMERS - FCN 680

Total Records: 908

Due Date
09/03/2010 EARL MARTIN MCGUIRE PSC
2010-6011 08/06/2010 CFSAN/OCD/EOS/ MARK N DUVALL TRIS (2,4-DI-TERT-BUTYLPHENYL) PHOSPHITE - FCN 112,
09/03/2010 BEVERIDGE & DIAMOND PC FCN 268, FCN 385, ETC
2010-6012 08/06/2010 ORA/ JASON DEAREN DEEPWATER HORIZON OIL SPILL - RPTS FROM TESTS OF
09/03/2010 OM/OSS/OPILS/DFI/ ASSOCIATED PRESS FISH FROM THE GULF OF MEXICO
OM/OSS/OPILS/DFI/
2010-6013 08/06/2010 OC/OM/OMP/DDM/ I. DAGUISO DKTS 1993N-0226, 1992N-0406, 1992P-0441
09/03/2010 HOGAN LOVELLS US LLP
2010-6014 08/06/2010 OC/OM/OMP/DDM/ RACHELLE LLONTOP DKT FDA-1978-N-0022 ( LEGACY 1978N-0301)
09/03/2010 ARENT FOX LLP
2010-6015 08/06/2010 CFSAN/OCD/EOS/ JULIA JARAMIIIO DL50 - STRUCTURAL & CONDENSATE FORMULA,
ANALYTICAL METHODS, TOXICOLOGICAL STUDIES, ETC
09/03/2010 OXITENO
2010-6016 08/06/2010 CBER/OCTMA/DDOM/ALFB/ THOMAS MADDEN NEEDLE STICK INJURIES IN AMERICAN WORKPLACES -
RECS, STATISTICS 1/06 TO PRESENT
09/03/2010 TRANSMEDIA
2010-6017 08/06/2010 OM/OSS/OPILS/DFI/ EMILY STEVENSON MEETING OF THE US-CANADA-MEXICO TRILATERAL
09/03/2010 OM/OSS/OPILS/DFI/ ALLIANCE FOR NATURAL COORPERATION CHARTER, CANADA-US-MEXICO
COMPLIANCE INFORMATION GROUP, ETC - MINS
HEALTH USA
2010-6018 08/09/2010 ORA/CE-FO/PHI-DO/PCB/ KATHY CONACHER DRAGER MEDICAL SYSTEMS INC, TELFORD, PA - EIR
09/07/2010 DRAGER MEDICAL INC 5/20/08-6/2/08
2010-6019 08/09/2010 CFSAN/OCD/EOS/ NANCY H MILLER ALOE VERA IN FOOD & BEVERAGES - GRAS NOTICE
09/07/2010 NSF International
2010-6020 08/09/2010 CDER/ORP/DIDP/ JANE CAI SPONSORS, MANUFACTURES OF HUMAN
PHARMACEUTICALS - RECS
09/07/2010 CDER/ORP/DIDP/ SHANGHAI NEWAY
PHARMACEUTICAL CO LTD
2010-6021 08/09/2010 CFSAN/OCD/EOS/ LVA WANJEK DEHYDRATED PARSLEY GRANULES ENTRY #337-0097306-
9 - ANALYSIS RESULTS
09/07/2010 ORA/CE-FO/CHI-DO/CCB/ W SCHUMACHER & CO GMBH
2010-6022 08/09/2010 OC/OSHC/OPD/ DANIEL R GETTS PHD BPT PHARMACEUTICALS INC - PROENZY
(GLYERALDEHYDE-3-PHOSPHATE DEHYDROGENASE)
09/07/2010 TOLERA THERAPEUTICS INC
ORPHAN DRUG APPLICATION
2010-6023 08/09/2010 CFSAN/OCD/EOS/ HELENA HOWELL 2010-464
09/07/2010 OM/OSS/OPILS/DFI/ HOGAN LOVELLS US LLP
OM/OSS/OPILS/DFI/
2010-6024 08/09/2010 CDER/ORP/DIDP/ JOANNE S HAWANA ISRS 6553757, 6559149, 6569744, ETC
09/07/2010 CDER/ORP/DIDP/ ARENT FOX LLP

Total Records: 908

Due Date
2010-6025 08/09/2010 CDER/ORP/DIDP/ ANGELIA D SLAYTON WYETH CONS - ADVIL CONGESTION RELIEF
09/07/2010 CDER/ORP/DIDP/ KENDLE REGULATORY AFFAIRS (IBUPROPHEN, PHENYLEPHRINE HCL) NDA 22-565 APRVL
LTR, LBLG, RVWS, ETC
2010-6026 08/09/2010 CDRH/OMO/DEMO/FOIB/ INITRAOCULAR LENSES (IOLS) - MODULATION TRANSFER
09/07/2010 EYE FOUNDATION OF CANADA FUNCTION (MTF) RECS
2010-6027 08/09/2010 CDER/ORP/DIDP/ JASON D'AGNENICA MERCK & CO INC - VIOXX INVESTIGATION RECS 1992 TO
PRESENT
09/07/2010 CDER/ORP/DIDP/ STULL STULL & BRODY
2010-6028 08/09/2010 CDRH/OMO/DEMO/FOIB/ CARMELINA G ALLIS WILLIAM MACFARLAND, HEATHER ROSECRANS -
09/07/2010 Hyman, Phelps & McNamara, P.C. CONFERENCE CALL MEMO TO FILE 8/5/10
2010-6029 08/09/2010 ORA/SE-FO/FLA-DO/FCB/ GILBERT R WEINER ALLIED RESEARCH, MIAMI GARDENS, FL - EIR 8/07
09/07/2010 ADVANCEDPHARMA
2010-6030 08/09/2010 ORA/SW-FO/DEN-DO/COMP/ GRANT RAMALEY ASI MEDICAL - 483 10/5/09
09/07/2010 ASEPTICO INC
2010-6031 08/09/2010 CDER/ORP/DIDP/ WALTER E CHALKLEY MULDER HENK MD, ROTTERDAM, NETHERLANDS - EIRS,
09/07/2010 CDER/ORP/DIDP/ THOMSON REUTERS 483S, CO RESP 6/09
2010-6032 08/09/2010 ORA/SE-FO/FLA-DO/FCB/ WALTER E CHALKLEY STUART A HARLIN, PENSACOLA, FL - EIRS, 483S, CO RESP
09/07/2010 THOMSON REUTERS 5/17-21/10
2010-6033 08/09/2010 ORA/CE-FO/MIN-DO/MCB/ WALTER E CHALKLEY GENTRAC, MIDDLETON, WI - EIR, 483, CO RESP 4/7-16/08
2010-6034 08/09/2010 ORA/P-FO/LOS-DO/LACB/ WALTER E CHALKLEY COHAN LYDIA MD, SCOTTSDALE, AZ - EIR, 483, CO RESP
6/09
2010-6035 08/09/2010 CDER/ORP/DIDP/ WALTER E CHALKLEY DIVIS LABS, AMEERPET, HYDERABAD, INDIA - EIR, 483, CO
09/07/2010 CDER/ORP/DIDP/ THOMSON REUTERS RESP 9/11-15/00
2010-6036 08/09/2010 ORA/SE-FO/FLA-DO/FCB/ DANA THOMPSON SANCILIO & COMPANY INC, RIVIERA BEACH, FL - EIRS, 482,
483, ETC 12/09 TO PRESENT
09/07/2010 FULBRIGHT & JAWORSKI LLP
2010-6037 08/09/2010 ORA/CE-FO/CHI-DO/CCB/ WALTER E CHALKLEY GE HEALTHCARE INTEGRATED IT SOLUTIONS,
BARRINGTON, IL - EIR, 483, CO RESP 4/15/08-5/13/08
2010-6038 08/09/2010 ORA/CE-FO/NJ-DO/NJCB/ DANA THOMPSON TRIGEN LABORATORIES INC, SAYREVILLE, NJ - EIRS, 482,
09/07/2010 CDER/ORP/DIDP/ FULBRIGHT & JAWORSKI LLP 483, ETC 12/09 TO PRESENT
CDER/ORP/DIDP/
2010-6039 08/09/2010 ORA/SW-FO/DEN-DO/COMP/ WALTER E CHALKLEY GE OEC MEDICAL SYSTEMS, SALT LAKE CITY, UT - EIR,
483, CO RESP 11/15/04-12/1/04
2010-6040 08/09/2010 ORA/SE-FO/FLA-DO/FCB/ DANA THOMPSON R/S TECH-PROB SOLUTIONS LLC, TEQUESTA, FL - EIRS,

Total Records: 908

Due Date
09/07/2010 FULBRIGHT & JAWORSKI LLP 482, 483, ETC 12/09 TO PRESENT
2010-6041 08/09/2010 CDER/ORP/DIDP/ WALTER E CHALKLEY USV LTD, MAHARESHTRA, INDIA - EIR, 483, CO RESP 11/7-
09/07/2010 CDER/ORP/DIDP/ THOMSON REUTERS 9/02
2010-6042 08/09/2010 ORA/P-FO/LOS-DO/LACB/ DANA THOMPSON IRISYS INC, SAN DIEGO, CA - EIRS, 482, 483, ETC 12/09 TO
09/07/2010 FULBRIGHT & JAWORSKI LLP PRESENT

2010-6045 08/09/2010 ORA/P-FO/LOS-DO/LACB/ DANA THOMPSON CAPTEK SOFTGEL INTERNATIONAL INC, CERRITOS, CA -
09/07/2010 FULBRIGHT & JAWORSKI LLP EIRS, 482, 483, ETC 2/10 TO PRESENT
2010-6046 08/09/2010 OM/OSS/OPILS/DFI/ WILLIAM A OLSON PHD FOI DAILY LOG 7/26-30/10
SOURCE
09/07/2010 OM/OSS/OPILS/DFI/ WOLTERS KLUWER LAW &
BUSINESS
2010-6049 08/09/2010 OM/OSS/OPILS/DFI/ CECELIA FRENCH FOI DAILY LOG 7/26-30/10
2010-6050 08/09/2010 CDRH/OMO/DEMO/FOIB/ BOSTON SCIENTIFIC - MODIFIED BILIARY WALLSTENT
2010-6051 08/09/2010 CDRH/OMO/DEMO/FOIB/ ELLMAN INTL - SURGI-MAX K061174

2010-6052 08/09/2010 CDRH/OMO/DEMO/FOIB/ WL GORE - VIABIL BILIARY ENDOPROSTHESIS K081184
2010-6053 08/09/2010 OM/OSS/OPILS/DFI/ 2010-5481
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
2010-6054 08/09/2010 OM/OSS/OPILS/DFI/ 2008-975
OM/OSS/OPILS/DFI/

Total Records: 908

Due Date
OM/OSS/OPILS/DFI/
2010-6055 08/09/2010 OM/OSS/OPILS/DFI/ 2006-16277
2010-6056 08/09/2010 OM/OSS/OPILS/DFI/ 2009-3608
2010-6057 08/09/2010 OM/OSS/OPILS/DFI/ 2009-424
2010-6058 08/09/2010 OM/OSS/OPILS/DFI/ 2009-4497
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
2010-6059 08/09/2010 OM/OSS/OPILS/DFI/ 2009-4383
2010-6060 08/09/2010 OM/OSS/OPILS/DFI/ 2009-7281
2010-6061 08/09/2010 OM/OSS/OPILS/DFI/ 2009-7101
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
2010-6062 08/09/2010 OM/OSS/OPILS/DFI/ CLOSED 510KS 7/-31/10
CDRH/OMO/DEMO/FOIB/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
2010-6063 08/10/2010 CDER/ORP/DIDP/ JOAN STITT (UG2CD-16) MERCK RESEARCH LABS - SINGULAIR (MONTELUKAST
SODIUM) ISRS 6391169-0, 6403191-6, 6405894-6, ETC
09/08/2010 CDER/ORP/DIDP/ MERCK & CO., INC.
2010-6064 08/10/2010 CDER/ORP/DIDP/ JOAN STITT (UG2CD-16) MERCK & CO INC - JANUVIA/JANUMET (SITAGLIPTIN
PHOSPHATE/SITAGLIPTIN, METFORMIN) ISR 6566020-6
09/08/2010 CDER/ORP/DIDP/ MERCK & CO., INC.
2010-6065 08/10/2010 CDER/ORP/DIDP/ JOAN STITT (UG2CD-16) MERCK & CO INC - ISENTRESS (RALTEGRAVIR) ISR
09/08/2010 CDER/ORP/DIDP/ MERCK & CO., INC. 6039765-4, 6803233-X
2010-6066 08/10/2010 CDER/ORP/DIDP/ JOAN STITT (UG2CD-16) MERCK & CO INC - INVANZ (ERTAPENEM SODIUM) ISR
09/08/2010 CDER/ORP/DIDP/ MERCK & CO., INC. 6439823-6
2010-6067 08/10/2010 CDRH/OMO/DEMO/FOIB/ AMY E BOYD BUCKMAN CO INC - CONTINUUM KNEE SYS K882322; DOW

Total Records: 908

Due Date
09/08/2010 FOLEY HOAG LLP CORNING WRIGHT - LACEY PRESS-FIT CONDYLAR TOTAL
KNEE K864518, WHITESIDE ORTHOLOC MA TOTAL KNEE
SYS K893252, ETC
2010-6068 08/10/2010 CDRH/OMO/DEMO/FOIB/ AMY E BOYD ORTHOMET INC - SECOND GERNERATION KNEE SYS
09/08/2010 FOLEY HOAG LLP K894334, AXIOM TOTAL KNEE SYS K932677; ORTHO
DEVELOPMENT CORP - BALANCED KNEE SYS K994370,
ETC
2010-6069 08/10/2010 CDRH/OMO/DEMO/FOIB/ AMY E BOYD HOSPTIAL FOR SPECIAL SURGERY - INSALL-BURSTEIN II
(PR) K935080; INTERMEDICS ORTHOPEDICS - HOFFMAN
09/08/2010 FOLEY HOAG LLP
KNE/NATURAL KNEE (PR) K853991; INTERMEDICS
ORTHOPEDICS - NATURAL-KNEE SYS W/COCR/CSTI (PR)
K902335, ETC
2010-6070 08/10/2010 CDRH/OMO/DEMO/FOIB/ AMY E BOYD ENCORE ORTHOPEDICS INC - FOUNDATION KNEE SYS
09/08/2010 FOLEY HOAG LLP K92327, K96008; EXACTECH INC - POROUS COATED
CRUCIATED RETAINED FEMORAL COMPONENT (PR)
K933526, PORUS COATED POSTERIOR STABILIZED
FEMORAL COMPONET (SR) K935773, ETC
2010-6071 08/10/2010 ORA/P-FO/SEA-DO/SCB/ CRICKET SPARKS CMPLNT #98980
09/08/2010 MOUNTAIN MEADOW HERBS INC
2010-6072 08/10/2010 CDRH/OMO/DEMO/FOIB/ AMY E BOYD BIOMET INC - AGC TOTAL KNEE P ROSTHESIS (PR)
09/08/2010 FOLEY HOAG LLP K833921, FINN KNEE PROSTESIS (PR) K910877, MCK
MAXIMUM CONGRUENT KNEE SYSTEM (PR) K915132, ETC
2010-6073 08/10/2010 CDRH/OMO/DEMO/FOIB/ DANIEL W ERNSBERGER MEDTRONIC INC - SYNCROMED II & CATHETER MDRS,
CMPLNTS, VIOLATIONS, ETC
09/08/2010 ORA/ BEHREND & ERNSBERGER PC
ORA/P-FO/SAN-DO/SFCB/
2010-6074 08/10/2010 ORA/CE-FO/PHI-DO/PCB/ CHERYL PENROD ALLEGHENY GENERAL HOSPITAL - PSEUDOMONAS
09/08/2010 PRIBANIC & PRIBANIC LLC OUTBREAK INVESTIGATION 10/02
2010-6075 08/10/2010 CDRH/OMO/DEMO/FOIB/ SAM KUMAR DISPOSABLE SYRINGES & DISPOSABLE NEEDLES -
09/08/2010 MYCO MEDICAL K945225
2010-6076 08/10/2010 CDRH/OMO/DEMO/FOIB/ WAYNE MORSE TOTAL KNEE SURGETICS NAVIGATION SYS WITH IBLOCK
DOUMENTATION - K090953
09/08/2010 OPERATIV
2010-6077 08/10/2010 CFSAN/OCD/EOS/ KELLOGG CO - CEREAL RECALL 6/10 RECS

Total Records: 908

Due Date
09/08/2010 ORA/CE-FO/DET-DO/DCB/ MACPHERSON, JENNIFER L
2010-6078 08/10/2010 CDRH/OMO/DEMO/FOIB/ WAYNE MORSE SURGETIC ORTHO KNEELOGICS NAVIGATION SYS -
09/08/2010 OPERATIV K031196
2010-6079 08/10/2010 CDRH/OMO/DEMO/FOIB/ WAYNE MORSE NAVITRACK SYS OS KNEE UNIVERSAL - K06336
09/08/2010 OM/OSS/OPILS/DFI/ OPERATIV
OM/OSS/OPILS/DFI/
2010-6080 08/10/2010 CFSAN/OCD/EOS/ ADAM R BLOEDORN EPSILON-POLYLYSINE - GRAS 336
09/08/2010 Keller and Heckman LLP
2010-6081 08/10/2010 CDRH/OMO/DEMO/FOIB/ WAYNE MORSE STRYKER NAVIGATION SYS KNEE MODULE - K010204
09/08/2010 OPERATIV
2010-6082 08/10/2010 CDRH/OMO/DEMO/FOIB/ WAYNE MORSE ACUMEN SURGICAL NAVIGATION SYS - K031337
09/08/2010 OPERATIV
2010-6083 08/10/2010 CDRH/OMO/DEMO/FOIB/ WAYNE MORSE STRYKER NAVIGATION SYS KNEE MODULE - K022579
09/08/2010 OPERATIV
2010-6084 08/10/2010 CDRH/OMO/DEMO/FOIB/ LISA PETERSON HEALTHANYWHERE (HA) SYS - K091220
09/08/2010 QA CONSULTING INC
2010-6085 08/10/2010 CDRH/OMO/DEMO/FOIB/ ADVANCED BIONICS LLC - CLARION CII BIONIC EAR,
09/08/2010 HARDEN, ROBERT G HIRESOULTION BIONIC EAR SYS 510K, PMA
2010-6086 08/10/2010 CDRH/OMO/DEMO/FOIB/ RASHA AWI SAFILO SPA, PADOVA ITALY; MARCOLIN SPA, LONGARONE,
ITALY, LUXOTTICA SRL, AGORDO, BELLUNO, ITALY -
09/08/2010 OPTICAL EXCHANGE
OPTICAL FRAMES & SUNGLASSES DVC LISTING NUMBERS
2010-6087 08/10/2010 CFSAN/OCD/EOS/ ADAM R BLOEDORN ENZYME MODIFIED STEVIOL GLYCOSIDES - GRAS 337
2010-6088 08/10/2010 CFSAN/OCD/EOS/ ADAM R BLOEDORN L-THEANINE - GRAS 338
2010-6089 08/10/2010 CFSAN/OCD/EOS/ ADAM R BLOEDORN POLYGLUTAMIC ACID - GRAS 339
2010-6090 08/10/2010 CFSAN/OCD/EOS/ ADAM R BLOEDORN THEOBROMINE - GRAS 340
2010-6091 08/10/2010 CFSAN/OCD/EOS/ ADAM R BLOEDORN QUERCETIN - GRAS 341
2010-6092 08/10/2010 CFSAN/OCD/EOS/ ADAM R BLOEDORN OAT HULL FIBER - GRAS 342
2010-6093 08/10/2010 CFSAN/OCD/EOS/ ADAM R BLOEDORN WHEAT BRAN EXTRACT - GRAS 343

Total Records: 908

Due Date
2010-6094 08/10/2010 CFSAN/OCD/EOS/ ADAM R BLOEDORN BARLEY FIBER - GRAS 344
2010-6095 08/10/2010 CFSAN/OCD/EOS/ ADAM R BLOEDORN CARBOXYPEPTIDASE ENZYME - GRAS 345
2010-6096 08/10/2010 CFSAN/OCD/EOS/ ADAM R BLOEDORN FREEZE-DRIED FRUIT GAC POWDER - GRAS 346
2010-6097 08/10/2010 CFSAN/OCD/EOS/ ADAM R BLOEDORN CAFFEINE - GRAS 347
2010-6098 08/10/2010 CFSAN/OCD/EOS/ ADAM R BLOEDORN PINE TREE PHYTOSTEROL ESTERS - GRAS 335
2010-6099 08/10/2010 CFSAN/OCD/EOS/ ADAM R BLOEDORN GALACTO-OLIGOSACCHARIDES - GRAS 334
2010-6100 08/10/2010 CDER/ORP/DIDP/ KLAS LINGREN WUHAN GRAND PHARMACEUTICAL GROUP CO LTD,
WUHAN, PR - 483S 5/11-14/09
09/08/2010 CDER/ORP/DIDP/ APL PHARMA-SPECIALS
2010-6102 08/10/2010 CDER/ORP/DIDP/ ROBERT Y LIN MD ISRS 6700067, 6705157, 6758959, ETC
09/08/2010 CDER/ORP/DIDP/ NEW YORK DOWNTOWN
HOSPITAL
2010-6105 08/10/2010 CDER/ORP/DIDP/ KONI CROSSAN BRIMONIDINE TARTRATE, TIMOLOL MALEATE OPHTHALMIC
09/08/2010 CDER/ORP/DIDP/ ISTA PHARMACEUTICALS SOL ANDA 91-574 - RECS
2010-6106 08/10/2010 OM/OSS/OPILS/DFI/ FRAN KOCH FOI DAILY LOG 7/19-23/10. 7/26-30/10
2010-6107 08/10/2010 CDER/ORP/DIDP/ LORAZEPAM, ATIVAN, HALDOL INJ, ETC - AERS
2010-6108 08/10/2010 CDER/ORP/DIDP/ TERENCE J. SWEENEY ZOMETA FORM 2253 ATTACHMENTS
09/08/2010 CDER/ORP/DIDP/ TERENCE J SWEENEY LAW FIRM
2010-6109 08/11/2010 CDER/ORP/DIDP/ MATTHEW WHITAKER JOHN FRATTI MTG - MINS 7/31/10

Total Records: 908

Due Date
09/09/2010 CDER/ORP/DIDP/ WESTLAW COURTEXPRESS
2010-6110 08/11/2010 CDER/ORP/DIDP/ ROBERT POWELL ORTHO-MCNEIL - ORTHO EVRA AERS 2009-2010
09/09/2010 CDER/ORP/DIDP/ NBC NEWS
2010-6111 08/11/2010 CDRH/OMO/DEMO/FOIB/ GLEN FEYE WIRELESS MEDCARE LLC - VIVATRAK K101109
09/09/2010 ACCURATE CONSULTANTS INC
2010-6112 08/11/2010 CDER/ORP/DIDP/ ANGELIA D SLAYTON ABILIFY (ARIPIPRAZOLE) NDA 21-436 - APRVL TR, LBLG,
RVWS, ETC
09/09/2010 CDER/ORP/DIDP/ INFORMATION ACCESS
2010-6113 08/11/2010 CDER/ORP/DIDP/ MARIE A DRAY ALLERGAN INC - BOTOX (ONABOTULINUMTOXIN A) BL
09/09/2010 CDER/ORP/DIDP/ International Regulatory Affairs 103000/5210, BL 103000/5209 RISK EVALUATION &
MITIGATION STRATEGIES (REMS)
Group
2010-6114 08/11/2010 OM/OSS/OPILS/DFI/ CECELIA FRENCH CLOSED FOIA REQUESTS 8/2-6/10
2010-6115 08/11/2010 CDER/ORP/DIDP/ CAROLYNE BOURGET HUATEI BIOPHARM INC - 483 9/7-10/09
09/09/2010 CDER/ORP/DIDP/ BIODROGA INC
2010-6116 08/11/2010 OM/OSS/OPILS/DFI/ CLOSED FOIA REQUESTS 8/2-8/10
2010-6117 08/11/2010 CDER/ORP/DIDP/ MASSIMO CALABRESI EMAILS BTWN MARY H PARKS & ROBERT I MISBIN &
HYLTON JOFFE 11/27/07; EMAIL BTWN ROBERT MISBIN &
09/09/2010 CDER/ORP/DIDP/ TIME
MARY PARKS 11/27/07, ETC
2010-6118 08/11/2010 CDRH/OMO/DEMO/FOIB/ JENNIFER INNAMORATO TL10 TENSYMETER BLOOD PRESSURE MONITORING SYS -
09/09/2010 OM/OSS/OPILS/DFI/ FRANTZ MEDICAL K020537; 5L100 TENSMETER BLOOD PRESSURE
MONITORING SYS - K022783
OM/OSS/OPILS/DFI/ DEVELOPMENT
2010-6119 08/11/2010 CDRH/OMO/DEMO/FOIB/ JENNIFER INNAMORATO HEALTHSTATTS - BPRO AMBULATORY BLOOD PRESSURE
MONITORING SYS K060315
09/09/2010 FRANTZ MEDICAL
DEVELOPMENT
2010-6120 08/11/2010 OM/OMP/DODM/ MARILYNN WHITNEY PDAC MTG - THOMAS P LAUGHREN MD MEMO 11/16/06
(CERTIFIED)
09/09/2010 COVINGTON & BURLING LLP
2010-6121 08/11/2010 OM/OMP/DODM/ MARILYNN WHITNEY PDAC & PEDS A/C - THOMAS P LAUGHREN MD MEMO
8/16/04 (CERTIFIED)
2010-6122 08/11/2010 ORA/CE-FO/DET-DO/DCB/ MARILYNN WHITNEY MICHAEL TURIK, MD, INDIANAPOLIS, IN - EIRS 4/12/04 TO
09/09/2010 COVINGTON & BURLING LLP 5/5/04 (CERTIFIED)
2010-6123 08/11/2010 CDRH/OMO/DEMO/FOIB/ SERRAH NAMINI ATHENA GTX WVSM WIRELESS VITAL SIGNS MONITOR -
K101674
09/09/2010 SOTERA WIRELESS
2010-6124 08/11/2010 ORA/P-FO/LOS-DO/LACB/ THOMAS GRYTA GILEAD SCIENCES, SAN DIMAS, CA - 483S 1/10 TO 2/10,
CORR, FORMS

Total Records: 908

Due Date
09/09/2010 DOW JONES NEWSWIRE
2010-6125 08/11/2010 CDER/ORP/DIDP/ SRIRAM RAMANATHAN ALLERGAN - OPTICROM (SODIUM CROMOGLYCATE) EYE
09/09/2010 CDER/ORP/DIDP/ INNOPHARMA LLC DROPS NDA 18-155 LBLG
2010-6126 08/11/2010 CDER/ORP/DIDP/ NIR SHTAYER DVM BAXTER - TISSEEL (FIBRIN SEALANT) CLNCL STUDY RPTS
09/09/2010 CDER/ORP/DIDP/ OMRIX BIOPHARMCEUTICALS
CBER/OCTMA/DDOM/ALFB/
2010-6127 08/11/2010 CDER/ORP/DIDP/ HELEN PENG KEPPRA (LEVETIRACETAM) - AERS
09/09/2010 CDER/ORP/DIDP/ FAIRVIEW SOUTHDALE
HOSPITAL
2010-6128 08/11/2010 CDER/ORP/DIDP/ ROSE RELEVO CERTOLUZIMAB PERGOL (CP) - SUPPLEMENTAL APRVL
5/09
09/09/2010 CDER/ORP/DIDP/ Oregon Health and Science
University
2010-6129 08/11/2010 CDER/ORP/DIDP/ MICHAEL R COHEN RPH MS SCD MEDWATCH RPTS CODED AS MEDICATION ERRORS 7/1/10-
8/1/10
09/09/2010 CDER/ORP/DIDP/ INSTITUTE FOR SAFE
MEDICATION PRACTICES
2010-6130 08/11/2010 CDER/ORP/DIDP/ ZOLADEX - AERS
2010-6131 08/11/2010 CDER/ORP/DIDP/ MARILYNN WHITNEY ELI LILLY & CO INC - ROBERT TEMPLE MD APRVL LTR
09/09/2010 CDER/ORP/DIDP/ COVINGTON & BURLING LLP 8/3/04 (CERTIFIED)
2010-6132 08/11/2010 CDER/ORP/DIDP/ MARILYNN WHITNEY CYMBALTA (DULOXETINE) NDA 21-472 - APRVL RECS
09/09/2010 CDER/ORP/DIDP/ COVINGTON & BURLING LLP (CERTIFIED)
2010-6133 08/11/2010 CDER/ORP/DIDP/ MARILYNN WHITNEY MICHAEL TURIK MD, INDIANA UNIV HOSPITAL - LTR 6/15/04
(CERTIFIED)
09/09/2010 CDER/ORP/DIDP/ COVINGTON & BURLING LLP
2010-6134 08/11/2010 CDER/ORP/DIDP/ MARILYNN WHITNEY NDA 21-427 MEMO 6/18/04 (CERTIFIED)
2010-6138 08/11/2010 CBER/OCTMA/DDOM/ALFB/ VAL LMOORE BOVINE THROMBIN/THROMBIN NOS/THROMBIN LOCAL SOL
09/09/2010 ZYMOGENTICS INC - VAERS 6814574, 7300201, 7167553, ETC

Total Records: 908

Due Date
2010-6141 08/11/2010 OM/OSS/OPILS/DFI/ JOHN DOHERTY DIETARY SUPP FACILITIES US OR FOREIGN - 483S
09/09/2010 OM/OSS/OPILS/DFI/ IOVATE HEALTH SCIENCES
RESEARCH INC
2010-6142 08/11/2010 OM/OSS/OPILS/DFI/ MARILYNN WHITNEY RECOMMENDATIONS OF THE
09/09/2010 OM/OSS/OPILS/DFI/ COVINGTON & BURLING LLP PSYCHOPHARMACOLOGICAL DRUGS & PEDIATRIC A/C
9/16/04 (CERTIFIED)
2010-6143 08/11/2010 CVM/OCD/ BOBBY SCHOCHET MEDICATED FEED INSP RPT - FORM 2481
09/09/2010 OLSSON FRANK & WEEDA
2010-6144 08/11/2010 ORA/ORM/ DAVID P JORDAN LIST OF ALL FOREIGN & DOMESTIC DRUG INSP 5/10 TO
09/09/2010 THOMSON REUTERS PRESENT
2010-6145 08/11/2010 CDER/ORP/DIDP/ JOHN D. BEVAN 182723/42367 SEPRACOR INC - LUNESTA (ESZOPICLONE TABS) AERS
09/09/2010 CDER/ORP/DIDP/ Central Utah Correctional Facility
2010-6146 08/11/2010 CDER/ORP/DIDP/ JOHN D. BEVAN 182723/42367 SANOFI-AVENTIS US LLC - AMBIEN DCR (ZOLPICLEM
TARTRATE TABS) AERS
09/09/2010 CDER/ORP/DIDP/ Central Utah Correctional Facility
2010-6147 08/11/2010 CDER/ORP/DIDP/ JOHN D. BEVAN 182723/42367 BRISTOL-MYERS SQUIBB - DESYREL (TRAZOCLONE HCL
09/09/2010 CDER/ORP/DIDP/ Central Utah Correctional Facility TABS) AERS
2010-6148 08/11/2010 CDER/ORP/DIDP/ JOHN D. BEVAN 182723/42367 BRISTOL MYERS SQUIBB - DESYREL (TRAZOCLONE HCL
09/09/2010 CDER/ORP/DIDP/ Central Utah Correctional Facility TABS) PI
2010-6149 08/11/2010 OC/OM/OMP/DDM/ GARY LAZER DKT FDA- 2009-P-0123, FDA-2010-P-0196

09/09/2010 BUC & BEARDSLEY
2010-6150 08/11/2010 ORA/ AASHISH Y DESAI JILLIAN MICHAELS - FAT BURNER PRODS CONTAINING
CITRUS AURANTIUM CMPLNTS
09/09/2010 ORA/SW-FO/DEN-DO/COMP/ MOWER CARREON & DESAL LLP
2010-6151 08/11/2010 CDER/ORP/DIDP/ MARILYNN WHITNEY ELI LILLY AND CO MTG - CYMBALTA NDA 21-427 MINS
09/09/2010 CDER/ORP/DIDP/ COVINGTON & BURLING LLP 11/17/06
2010-6152 08/11/2010 CDER/ORP/DIDP/ MARILYNN WHITNEY EMAIL BTWN PAUL DAVID RPH & BARBARA ARNING, ELI
09/09/2010 CDER/ORP/DIDP/ COVINGTON & BURLING LLP LILLY & CO REGARDING PROZAC/CYMBALTA/SYMBAX
MEDICATION GUIDES 10/21/04 (CERTIFIED)
2010-6153 08/11/2010 CDER/ORP/DIDP/ MARILYNN WHITNEY EMAIL BTWN PAUL DAVID RPH & BARBARA ARNING, ELI
LILLY & CO REGARDING PROZAC/CYMBALTA/SYMBYAX
MEDICATION GUIDES 10/27/04 (CERTIFIED)
2010-6154 08/11/2010 CDER/ORP/DIDP/ MARILYNN WHITNEY ELI LILLY & CO - RUSSELL KATZ MD LTR 1/26/05, LBLG
09/09/2010 CDER/ORP/DIDP/ COVINGTON & BURLING LLP GUIDE (CERTIFIED)

Total Records: 908

Due Date
2010-6155 08/11/2010 CDER/ORP/DIDP/ MARILYNN WHITNEY ELI LILLY & CO - NDA 21-427/S002 APRVL LTR 2/18/05, PI
2010-6156 08/11/2010 CDER/ORP/DIDP/ MARILYNN WHITNEY CYMBALTA NDA 21-733 - DIVISION DIRECTOR RVW 9/3/04,
09/09/2010 CDER/ORP/DIDP/ COVINGTON & BURLING LLP BASIS FOR APRVL ACTION (CERTIFIED)
2010-6157 08/11/2010 OM/OSS/OPILS/DFI/ 2009-4220

2010-6158 08/11/2010 OM/OSS/OPILS/DFI/ 2010-1480
2010-6159 08/11/2010 OM/OSS/OPILS/DFI/ 2010-3777
2010-6160 08/11/2010 OM/OSS/OPILS/DFI/ 2010-4190, 2010-4191
2010-6161 08/11/2010 OM/OSS/OPILS/DFI/ 2010-4230
2010-6162 08/11/2010 OM/OSS/OPILS/DFI/ 2010-4829
2010-6163 08/11/2010 ORA/CE-FO/BLT-DO/CB/ CMPLNT 115245
09/09/2010 AXEL, STANLEY
2010-6164 08/11/2010 ORA/SE-FO/ATL-DO/ACB/ CMPLNT 114518
09/09/2010 MILLER., DAVID
2010-6165 08/12/2010 OM/OSS/OPILS/DFI/ 2010-5769 REQUEST LTR
2010-6166 08/12/2010 CDER/ORP/DIDP/ FRAN DAUGHTRIDGE THROMBIN - ISR 6653286
09/10/2010 CDER/ORP/DIDP/ FRAN DAUGHTRIDGE PHARMD
2010-6167 08/12/2010 CDER/ORP/DIDP/ FRAN DAUGHTRIDGE EMBEDA - ISRS 653513, 6542292, 6611887, ETC
09/10/2010 CDER/ORP/DIDP/ FRAN DAUGHTRIDGE PHARMD
2010-6168 08/12/2010 CDRH/OMO/DEMO/FOIB/ DAVID A GREER ARROW INTERNATIONAL - A2 DUAL PORT SYS K955819
09/10/2010 ANGIODYNAMICS INC
2010-6169 08/12/2010 CDRH/OMO/DEMO/FOIB/ DAVID A GREER ARROW INTERNATIONAL - A2 PORT DUAL LUMEN SYS
09/10/2010 ANGIODYNAMICS INC WITH DETACHER CATHETER K963684
2010-6170 08/12/2010 CDRH/OMO/DEMO/FOIB/ TIM TRUITT COAST MEDICAL - K943270

09/10/2010 TRUER MEDICAL INC
2010-6171 08/12/2010 CDRH/OMO/DEMO/FOIB/ TIM TRUITT COAST MEDICAL - K930930

Total Records: 908

Due Date
09/10/2010 TRUER MEDICAL INC
2010-6172 08/12/2010 OM/OSS/OPILS/DFI/ 2009-8731
2010-6173 08/12/2010 OM/OSS/OPILS/DFI/ 2009-8752
2010-6174 08/12/2010 OM/OSS/OPILS/DFI/ 2009-9321
2010-6175 08/12/2010 OM/OSS/OPILS/DFI/ 2009-9337
2010-6176 08/12/2010 OM/OSS/OPILS/DFI/ 2009-9386
2010-6177 08/12/2010 OM/OSS/OPILS/DFI/ 2009-9393
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
2010-6178 08/12/2010 OM/OSS/OPILS/DFI/ 2009-9395
2010-6179 08/12/2010 OM/OSS/OPILS/DFI/ 2009-9533
2010-6180 08/12/2010 OM/OSS/OPILS/DFI/ 2007-5973
2010-6181 08/12/2010 OM/OSS/OPILS/DFI/ 2009-8683
2010-6182 08/12/2010 OM/OSS/OPILS/DFI/ 2009-8559
2010-6183 08/12/2010 OM/OSS/OPILS/DFI/ 2009-8411
2010-6184 08/12/2010 OM/OSS/OPILS/DFI/ 2009-8171
2010-6185 08/12/2010 OM/OSS/OPILS/DFI/ 2009-7891
2010-6186 08/12/2010 ORA/ ALPO PURINA CAT FOOD - TEST RESULTS, RECS
09/10/2010 ORA/ORO/DFS/ Doe J

Total Records: 908

Due Date
CVM/OCD/
ORA/ORO/DFI/
2010-6187 08/12/2010 CDER/ORP/DIDP/ JILL DAVIDSON RN SPECTRUM LABORATORY PRODUCTS - TACROLIMUS
RECALL INVESTIGATION RECS 5/11/06; RECALL #D-1567-
09/10/2010 CDER/ORP/DIDP/ NIXON RAICHE ET AL
2009 7/22/09
2010-6188 08/12/2010 ORA/NE-FO/NYK-DO/NYDCB/ CHERYL ANTONNAZZI FINE SURGICAL INSTRUMENT INC, HEMPSTEAD, NY - EIR
09/10/2010 GF HEALTH PRODUCTS INC 9/14/09
2010-6189 08/12/2010 CVM/OCD/ FORSTER & ASSOCIATES CONSULTING LLC, GREAT

PLAINS OIL & EXPLORATION INC (SUSTAINABLE OILS LLC)
09/10/2010 BOWMAN, RICHARD
- CAMELINA OIL SEED MEAL CORR, PROTOCOLS, RPTS,
ETC
2010-6190 08/12/2010 ORA/SE-FO/FLA-DO/FCB/ GILBERT R WEINER DO ALLIED RESEARCH, MIAMI, FL - EIR 8/07
09/10/2010 ADVANCEDPHARMA
2010-6191 08/12/2010 ORA/SW-FO/KAN-DO/COMP/ CMPLNT #115262
09/10/2010 ORA/SW-FO/DAL- CARREON, YOLANDA
DO/COMPLIANCE/
2010-6192 08/12/2010 OM/OSS/OPILS/FDAHO/ DR JOHN BRINKLEY - RECS
09/10/2010 LANE, PENNY JEANNE
2010-6193 08/12/2010 CDRH/OMO/DEMO/FOIB/ GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPS, ESO
09/10/2010 FOI SERVICES INC CAPS & AGILE PATENCY SYS - K090557
2010-6194 08/12/2010 CDRH/OMO/DEMO/FOIB/ PILLCAM WITH PILLCAM SB CAPS WITH PILLCAM

SENSORBELT K091405
2010-6195 08/12/2010 CDRH/OMO/DEMO/FOIB/ GIVEN DIAGNOSTIC SYS WITH PILLCAM ESO2 CAPS
K071153
2010-6196 08/12/2010 CDRH/OMO/DEMO/FOIB/ GIVEN DIAGNOSTIC IMAGING SYS - K070475
2010-6197 08/12/2010 CDRH/OMO/DEMO/FOIB/ GIVEN DIAGNOSTIC SYS - K062786
2010-6198 08/12/2010 CDRH/OMO/DEMO/FOIB/ MONICA MORRISON VENTURI VENTILATOR - k943412
09/10/2010 GE HALTHCARE

Total Records: 908

Due Date
2010-6199 08/12/2010 CDRH/OMO/DEMO/FOIB/ GIVEN DIAGNOSTICS SYS MODIFICATION - K060805
2010-6200 08/12/2010 CDRH/OMO/DEMO/FOIB/ NORMAN F ESTRIN PHD FORTUNE MEDICAL INSTRUMENT CORP, TAIPEI HSIEN,
09/10/2010 OM/OSS/OPILS/DFI/ ESTRIN CONSULTING GROUP TAIWAN - ALL SILICONE SUPRA-PUBLA CATHETER
K014002
OM/OSS/OPILS/DFI/ INC
2010-6201 08/12/2010 ORA/CE-FO/PHI-DO/PCB/ DERICK JANIK ADVANCE FOOD PRODUCTS, NEW HOLLAND, PA - EIRS,
483S, 482S
09/10/2010 Giant Eagle
2010-6202 08/12/2010 CFSAN/OCD/EOS/ REBECCA S DICKSON FOOD INGREDIENT SOLUTIONS - SODIUM COPPER
09/10/2010 Hyman, Phelps & McNamara, P.C. CHLOROPHYLLIN CAP 6C0281

2010-6205 08/12/2010 CDRH/OMO/DEMO/FOIB/ GIVEN DIAGNOSTIC SYS WITH PILLCAM ESO - K042960
2010-6206 08/12/2010 CDRH/OMO/DEMO/FOIB/ GIVEN DIAGNOSTIC SYS WITH M2A ESO CAP - K041149
2010-6207 08/12/2010 CDRH/OMO/DEMO/FOIB/ GIVEN DIAGNOSTIC SYS MODIFICATIONS - K040248
2010-6208 08/12/2010 CDRH/OMO/DEMO/FOIB/ GIVEN DIAGNOSTIC SYS WITH REVISED INDICATIONS -
K031033
2010-6209 08/12/2010 CDRH/OMO/DEMO/FOIB/ GIVEN DIAGNOSTIC MODIFICATION - K022980
2010-6211 08/12/2010 CDER/ORP/DIDP/ FLUXOME, CP KELCO US INC - YEAST-DERIVED
EICOSAPENTANOIC ACID RECS
2010-6212 08/12/2010 CDRH/OMO/DEMO/FOIB/ GIVEN DIAGNOSTIC SYS WITH LOCALIZATON MODULE -
K020341
2010-6213 08/12/2010 CDRH/OMO/DEMO/FOIB/ MORAX - HYDRAGEL IF, 6 IF, 12, IF PENTA KITS, ETC
2010-6214 08/12/2010 CDRH/OMO/DEMO/FOIB/ MORAX - HYDRAGEL BENCE JONES KIT/MAXI KIT

HYDRAGEL BENCE JONES, ETC K972591

Total Records: 908

Due Date
2010-6215 08/12/2010 CDRH/OMO/DEMO/FOIB/ ENOTECH - BUECHEL-PAPPAS (B-P) FIXED BEARING NEW
09/10/2010 OM/OSS/OPILS/DFI/ FOI SERVICES INC JERSEY (NJ) TOTAL KNEE K012702
OM/OSS/OPILS/DFI/
2010-6216 08/12/2010 CDRH/OMO/DEMO/FOIB/ HOWMEDICA OSTEONICS - RESTORATION ADM SYS X3
09/10/2010 FOI SERVICES INC ACETABULAR K093644
2010-6217 08/12/2010 CDRH/OMO/DEMO/FOIB/ APRIL HOLLIS WU'S TECH CO, HSIN CHU CITY, TW; SYNTEC SCIENTIFIC,
CHANG HUA, TW; DIGITAL AGE DENTAL LABORATORIES,
09/10/2010 FDA NEWS
HO CHIN MINH, VN, ETC - 483S 7/1-31/10
2010-6218 08/12/2010 ORA/CE-FO/PHI-DO/PCB/ APRIL HOLLIS HAWKEYE JENSEN, SHARTLESVILLE, PA; PEREGRINE
09/10/2010 FDA NEWS SURGICAL, NEW BRITAIN,PA; JOHNSON & JOHNSON
MERCK CONSUMER PHARMS, LANCASTER, PA - 483S 7/1-
31/10
2010-6219 08/12/2010 ORA/SE-FO/SJN-DO/SJCB/ APRIL HOLLIS MEDTRONIC PUERTO RICO, HUMACAO, PR - 483S 7/1-31/10
09/10/2010 FDA NEWS
2010-6220 08/12/2010 ORA/CE-FO/MIN-DO/MCB/ APRIL HOLLIS FRONTIER MEDICAL PRODUCTS, PORT WASHINGTON, WI;
MINNTECH CORP, PLYMOUTH, MN; AUGUSTINE
09/10/2010 FDA NEWS
BIOMEDICAL, EDEN PRAIRIE, MN, ETC - 483S 7/1-31/10
2010-6221 08/12/2010 ORA/SE-FO/NOL-DO/NOCB/ APRIL HOLLIS A1&S, DE KALB, MS - 483S 7/1-31/10
09/10/2010 FDA NEWS
2010-6222 08/12/2010 ORA/NE-FO/NWE-DO/NWECB/ APRIL HOLLIS HEALEX PRODUCTS, PROVIDENCE, RI; MULTI-MED,
09/10/2010 FDA NEWS KEENE, NH; ORGANOGENESIS, CANTON, MA, ETC - 483S
7/1-31/10
2010-6223 08/12/2010 ORA/SW-FO/KAN-DO/COMP/ APRIL HOLLIS 483S ISSUED BY KANSAS CITY DISTRICT 7/1-31/10
09/10/2010 FDA NEWS
2010-6224 08/12/2010 ORA/SE-FO/FLA-DO/FCB/ APRIL HOLLIS INTRA-LOCK INTERNATIONAL, BOCA RATON, FL; RITE-
09/10/2010 FDA NEWS DENT MANUFACTURING, HIALEAH, FL; SANDER
SCIENTIFIC, VERO BEACH, FL, ETC - 483S 7/1-31/10
2010-6225 08/12/2010 ORA/SW-FO/DEN-DO/COMP/ APRIL HOLLIS CME AMERICA, GOLDEN, CO - 483S 7/1-31/10
09/10/2010 FDA NEWS
2010-6226 08/12/2010 ORA/CE-FO/BLT-DO/CB/ APRIL HOLLIS MERCK, ELKTON, VA; AMERICAN IV PRODUCTS, HARMANS,
MD; MEDLENS INNOVATIONS, FRONT ROYAL, VA - 483S
09/10/2010 FDA NEWS
7/1-31/10
2010-6227 08/12/2010 OC/OM/OMP/DDM/ MERLE ZIMMERMANN DKT LOG FDA-1995-S-0039
09/10/2010 AMERICAN HERBAL PRODUCTS
ASSOCIATION
2010-6228 08/12/2010 ORA/CE-FO/CHI-DO/CCB/ APRIL HOLLIS BALCHEM CORP, CHANNAHON, IL; ABBOTT MOLECULAR,
09/10/2010 FDA NEWS DES PLAINES, IL - 483S 7/1-31/10

Total Records: 908

Due Date
2010-6229 08/12/2010 OC/OM/OMP/DDM/ SUZANNE JAMES DKT 1998P-0683
09/10/2010 DuPont
2010-6230 08/12/2010 ORA/CE-FO/PHI-DO/PCB/ DARLENE GILPIN PHAMAKON RESEARCH INTERNATIONAL - EIRS 1/27/92,
09/10/2010 CALVERT LABS 11/15/93
2010-6231 08/12/2010 ORA/ APRIL HOLLIS ESTEVE QUIMICA, TARRAGONA, ES; ESTEVE QUIMICA,
CELRA, ES - 483S 7/0-31/10
CDER/ORP/DIDP/
2010-6232 08/12/2010 ORA/P-FO/SEA-DO/SCB/ APRIL HOLLIS SAGEMAX BIOSCIENCES, AUBURN, WA - 483S 7/1-31/10
09/10/2010 FDA NEWS
2010-6233 08/12/2010 ORA/P-FO/SAN-DO/SFCB/ APRIL HOLLIS NOVARTIS VACCINE & DIAGNOSTICS, EMERYVILLE, CA;
09/10/2010 FDA NEWS GENESIS PHARMACEUTICAL, HENDERSON, NV; ASI
MARKETING GROUP, LAS VEGAS, NV, ETC - 483S 7/1-31/10
2010-6234 08/12/2010 ORA/NE-FO/NYK-DO/NYDCB/ APRIL HOLLIS KENDALL, ORISKANY FALLS, NY; ANSEN CORP,
OGDENSBURG, NY; ARNOLD TUBER INDUSTRIES,
09/10/2010 FDA NEWS
HAMBURG, NY - 483S 7/1-31/10
2010-6235 08/12/2010 ORA/CE-FO/NJ-DO/NJCB/ APRIL HOLLIS CONVATEC SKILLMAN, NJ; BIOTECH ATLANTIC,
09/10/2010 FDA NEWS EASTONTOWN, NJ; REPLICATION MEDICAL, CRANBURY,
NJ, ETC - 483S 7/1-31/10
2010-6236 08/12/2010 ORA/P-FO/LOS-DO/LACB/ APRIL HOLLIS KENWICK, INGLEWOOD, CA; RESPIRONICS CALIFORNIA,
CARLSBAD, CA; WHPM, EL MONTE, CA, ETC - 483S 7/1-
09/10/2010 FDA NEWS
31/10
2010-6237 08/12/2010 CDER/ORP/DIDP/ APRIL HOLLIS QILU PHARMACEUTICAL FACTORY, JINAN, CN; DERETIL,
09/10/2010 CDER/ORP/DIDP/ FDA NEWS ALMERIA, ES; NOVARTIS PHARMA, STEIN, CH, ETC - 483S
7/1-31/10
2010-6238 08/12/2010 ORA/CE-FO/DET-DO/DCB/ APRIL HOLLIS MICHCLONE ASSOCIATES, MADISON HEIGHTS, MI - 483S
7/1-31/10
09/10/2010 FDA NEWS
2010-6239 08/12/2010 ORA/SW-FO/DAL- APRIL HOLLIS BIO MEDICAL & PHARMACEUTICAL MANUFACTURING,
DO/COMPLIANCE/ HOUSTON, TX - 483S 7/1-31/10
09/10/2010 FDA NEWS
2010-6240 08/12/2010 ORA/CE-FO/CIN-DO/CCB/ APRIL HOLLIS SUN PHARMACEUTICAL INDUSTRIES, BRYAN OH; THEKEN
09/10/2010 FDA NEWS SPINE, AKRON, OH; MARLEN MANUFACTURING, BEDFORD,
OH - 483S 7/1-31/10
2010-6241 08/12/2010 ORA/SE-FO/ATL-DO/ACB/ APRIL HOLLIS GORBEC PHARMACEUTICAL SERVICES, DURHAM, NC -
483S 7/1-31/10
09/10/2010 FDA NEWS
2010-6242 08/12/2010 ORA/ORM/ CATHERINE LARKIN JOHNSON & JOHNSON - INSP OF ALL PLANTS SINCE 2000
09/10/2010 BLOOMBERG FINANCIAL
MARKETS COMMODITIES NEWS
2010-6243 08/12/2010 CDRH/OMO/DEMO/FOIB/ INTUITIVE SURGICAL, SUNNYVALE, CA - 483, PMA, 501K,

Total Records: 908

Due Date
09/10/2010 ORA/P-FO/SAN-DO/SFCB/ Doe J CO RESP 2004 TO 2009
2010-6244 08/13/2010 ORA/ V-8 JUICE INVESTIGATION - RECS
09/13/2010 ORA/CE-FO/CIN-DO/CCB/ Doe J
2010-6245 08/13/2010 CDER/ORP/DIDP/ CAROLYNE BOURGET HUATEL BIOPHARM INC - EIR, 483 9/7-10/10
09/13/2010 CDER/ORP/DIDP/ BIODROGA INC
2010-6246 08/13/2010 CDRH/OMO/DEMO/FOIB/ ALAIN NIGON MICROVENA CORP - AMPLATZ GOOSE NECK SNARE
KIT/CATHETER K972511
09/13/2010 ALN
2010-6247 08/13/2010 CFSAN/OCD/EOS/ CHEN LU GEORGIA-PACIFIC CHEMICALS LLC - FCN 973
09/13/2010 KEMIRA CHEMICAL INC
2010-6248 08/13/2010 OM/OSS/OPILS/DFI/ DARREN L SCHULTZ MCNEIL CONSUMER HEALTHCARE - EIRS 6/1/95-8/11/10
09/13/2010 OM/OSS/OPILS/DFI/ BRIAN D WITZER INC
ORA/SW-FO/DAL-
DO/COMPLIANCE/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
2010-6249 08/13/2010 ORA/ J TIM CRAWFORD INDIVIDUAL RECS
09/13/2010 ORA/ORO/DFS/ J TIM CRAWFORD LAW OFCS
2010-6250 08/13/2010 CFSAN/OCD/EOS/ OLGA NAIDENKO CHEMCIALS THAT MAY CONTAMINATE FOOD -
09/13/2010 ENVIRONMENTAL WORKING PACKAGING, COLOR ADDITIVES, HUMAN EXPOSURE, ETC
GROUP
2010-6251 08/13/2010 OM/OSS/OPILS/DFI/ DARREN L SCHULTZ MCNEIL CONSUMER HEALTHCARE - 483S 1/1/95-8/11/10
2010-6252 08/13/2010 CFSAN/OCD/EOS/ RACHEL DENK ISINGLASS - GRAS STATUS ADVISORY LTRS
09/13/2010 KERRY INGREDIENTS &
FLAVOURS
2010-6253 08/13/2010 CDER/ORP/DIDP/ PAMELA SHEPPARD GRACEWAY - ZYCLARA (IMIQUIMOD) NDA 22-483 SBA,
MOR, LBLG, ETC
09/13/2010 CDER/ORP/DIDP/ TARO PHARMACEUTICALS USA
INC
2010-6254 08/13/2010 CDER/ORP/DIDP/ JOHANNAH DRERUP ABT-924 - RECS
09/13/2010 CDER/ORP/DIDP/ COLLINS LAW FIRM
2010-6255 08/13/2010 ORA/OCI/ DONALD A BOGGS PE POWERMEDICA/METRAGEN PHARMS, DEERFIELD BEACH,
FL - INVESTIGATION 2/15/05

Total Records: 908

Due Date
09/13/2010 DONALD A BOGGS PE
2010-6256 08/13/2010 ORA/SE-FO/FLA-DO/FCB/ SHAMEEN AFIF-RIDER SOUTH FLORIDA BIOAVAILABILITY CLINIC - 483 5/15/06
09/13/2010 MEDIMMUNE LLC
2010-6257 08/13/2010 CTP/OD/ A ELIZABETH KNIGHT PHILIP MORRIS USA INC - LIST OF INGREDIENTS IN
09/13/2010 CTP/OD/ SCHWEITZER-MAUDUIT CIGARETTES 6/22/09 TO PRESENT
INTERNATIONAL INC
2010-6258 08/13/2010 ORA/SE-FO/FLA-DO/FCB/ KAY FLANAGAN MARTIN N ZAIAC MD, GREATER MIAMI SKIN & LASER
09/13/2010 STIEFEL LABORATORIES INC CENTER, MIAMI BEACH, FL - 483 4/10 TO 7/10
2010-6259 08/13/2010 CDER/ORP/DIDP/ TRINA THOMPSON NANJING KING-FRIEND BIOCHEMICAL PHARMACEUTICAL

COL, NANJING, CHINA - EIRS, 483S 2008-2010
09/13/2010 CDER/ORP/DIDP/ MCGUIRE WOODS LLP
2010-6260 08/13/2010 CDER/ORP/DIDP/ TRINA THOMPSON NANJING CILONG INTERNATIONAL, NANJING, CHINA -
09/13/2010 CDER/ORP/DIDP/ MCGUIRE WOODS LLP EIRS, 483S 2008-2010
2010-6261 08/13/2010 CDER/ORP/DIDP/ TRINA THOMPSON GLAND PHARMA LTD, HYDERABAD, INDIA - EIRS, 483S
09/13/2010 CDER/ORP/DIDP/ MCGUIRE WOODS LLP 2008-2010
2010-6262 08/13/2010 ORA/SW-FO/DAL- MICHELLE THOMAS GDMI INC, GARLAND, TX - EIRS 1/09 TO PRESENT
DO/COMPLIANCE/
09/13/2010 OCuSOFT, Inc.
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
2010-6263 08/13/2010 ORA/NE-FO/NYK-DO/NYDCB/ MICHELLE THOMAS ALTAIRE PHARMACEUTICALS INC, AQUEBOGUE, NY - EIRS
6/09 TO PRESENT
09/13/2010 OCuSOFT, Inc.
2010-6264 08/13/2010 OM/OSS/OPILS/DFI/ MARK P BAYER SPL ESTABLISHMENT DATA
INFORMATION SERVICES INC
2010-6265 08/13/2010 OM/OSS/OPILS/DFI/ DARREN L SCHULTZ MCNEIL CONSUMER HEALTHCARE - WARNING LTRS
1/1/95-8/11/10
2010-6266 08/13/2010 OM/OSS/OPILS/DFI/ CHRIS WEBB G & B SOLUTIONS - CONTRACT #GS06F0265Z
09/13/2010 OM/OSS/OPILS/DFI/ INPUT
2010-6267 08/13/2010 OM/OSS/OPILS/DFI/ ROBERT P CHARROW 2003-16423, 2005-9958, 2005-16543, ETC
09/13/2010 OM/OSS/OPILS/DFI/ GREENBERG TRAURIG LLP
2010-6268 08/13/2010 OC/OM/OMP/DDM/ JENNIFER PELAIA DKT & DKT LOG OF 1996N-0057,1996D-0049
2010-6269 08/13/2010 OC/OM/OMP/DDM/ SUZANNE JAMES DKT & DKT LOG OF 1998P-0683
09/13/2010 DuPont
2010-6270 08/16/2010 OM/OSS/OPILS/DFI/ CLOSED FOIA REQUESTS 8/2-6/10

Total Records: 908

Due Date
SOURCE
09/14/2010 OM/OSS/OPILS/DFI/ WALTERS KLUWER LAW &
BUSINESS
2010-6276 08/16/2010 CDRH/OMO/DEMO/FOIB/ ETHICON GMBH - PHYSIOMESH FLEXIBLE COMPOSITE
MESH
2010-6277 08/16/2010 CDRH/OMO/DEMO/FOIB/ GIVEN DIAGNOSTIC SYSTEMS WITH PEDIATRIC
09/14/2010 FOI SERVICES INC INDICATION - K032405
2010-6278 08/16/2010 CDRH/OMO/DEMO/FOIB/ LIFECELL CORP - LRTM SURGICAL MESH K070560

2010-6279 08/16/2010 CDRH/OMO/DEMO/FOIB/ GENZYME CORP - SEPRAAMESH MODEL 5959-1214
K063638
2010-6280 08/16/2010 CDER/ORP/DIDP/ BRAINTREE - HALFLYTELY NDA 21-551 APRVL RECS
2010-6281 08/16/2010 CDRH/OMO/DEMO/FOIB/ ABBOTT MOLECULAR - ABBOTT M2000SP, ABBOTT
09/14/2010 FOI SERVICES INC M2000RT K092705
2010-6282 08/16/2010 CDRH/OMO/DEMO/FOIB/ GENZYME CORP - SEPRAMESH IP BIORESORBABLE

COATING/PERMANENT MESH K053066
2010-6283 08/16/2010 CDRH/OMO/DEMO/FOIB/ GENZYME CORP - SEPRAMESH IP BIORESORBABLE
BARRIER PERMANENT MESH K040868
2010-6284 08/16/2010 ORA/CE-FO/NJ-DO/NJCB/ TIM SANDLER DENDREON - PROVENGE (SIPULEUCEL-T) EIRS, 483S, CO
09/14/2010 CBER/OCTMA/DDOM/ALFB/ NBC NEWS RESP, ETC
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/

Total Records: 908

Due Date
OM/OSS/OPILS/DFI/
2010-6285 08/16/2010 CDER/ORP/DIDP/ ANGELIA D SLAYTON ORTHO-MCNEIL JANSSEN - RISPERDAL (RISPERIDONE)
09/14/2010 CDER/ORP/DIDP/ KENDLE REGULATORY AFFAIRS NDA 20-272/S036,041; NDA 20-588/S024.S028,S029; NDA 21-
44/S008,S015 APRVL LTR, LBLG, RVWS, ETC
2010-6286 08/16/2010 CFSAN/OCD/EOS/ ADAM LECHTER GRINSTED PRODUCTS - SORBITAN TRISTEARATE GRASP
8G0339
09/14/2010 ADM, Cocoa
2010-6287 08/16/2010 CDRH/OMO/DEMO/FOIB/ GARY DORROUGH MW #5016822
09/14/2010 ARTHREX INC
2010-6288 08/16/2010 CDRH/OMO/DEMO/FOIB/ NESLON LAM INFECTION CONTROL SYMPOSIUM: INFLUENCE OF
09/14/2010 INTUITY MEDICAL MEDICAL DEVICE DESIGN, BETHESDA, MD - RECS 1/95
2010-6289 08/16/2010 CDER/ORP/DIDP/ ROCHE - BONIVA PI CHANGE

09/14/2010 CDER/ORP/DIDP/ STANTIAL, SARA
2010-6290 08/16/2010 CDER/ORP/DIDP/ EDUARDO SUAREZ-TROCONIS MERCK, DARMSTADT, GERMANY - EIR 2/10
09/14/2010 CDER/ORP/DIDP/ ALGON CORP
2010-6291 08/16/2010 CDER/ORP/DIDP/ INHALED METFORMIN - RECS
09/14/2010 CDER/ORP/DIDP/ LEHRER, STEVEN
2010-6292 08/16/2010 CDER/ORP/DIDP/ TERRY M HENRY ALLOPURINOL, ALOPRIM, ZYLOPRIM - WARNING & LBLG
09/14/2010 CDER/ORP/DIDP/ COZEN O'CONNOR PC LCHANGES
2010-6293 08/16/2010 ORA/CE-FO/CIN-DO/CCB/ BOYD HALEY, CTI SCIENCE INC, NEUROSCIENCE INC -
WARNING LTR RESP 6/17/10
09/14/2010 SEIDEL, KATHLEEN
2010-6294 08/16/2010 CBER/OCTMA/DDOM/ALFB/ SANOFI PASTEUR - SEASONAL FLU VACCINE VAERS
09/14/2010 Doe J
2010-6295 08/16/2010 CDER/ORP/DIDP/ LOUIS CHANG MIDAZOLAM - AERS 2000 TO PRESENT
09/14/2010 CDER/ORP/DIDP/ WONG & ASSOCIATES
2010-6296 08/16/2010 CDER/ORP/DIDP/ LOUIS CHANG ZIPRASIDONE - AERS 2000 TO PRESENT
09/14/2010 CDER/ORP/DIDP/ WONG & ASSOCIATES
2010-6298 08/16/2010 ORA/NE-FO/NWE-DO/NWECB/ BRADFORD MANNING UNH BIOSAFETY LEVEL 3 FACILITY (BSL-3) -
09/14/2010 UNIV OF NEW HAMPSHIRE INVESTIGATION RECS
ENVIRONMENTAL HEALTH &
SAFETY
2010-6299 08/17/2010 ORA/NE-FO/NYK-DO/NYDCB/ SUE CARLSON CARGILL ANIMAL NUTRITION, ALEXANDER, NY - EIRS 4/26-
27/10
09/15/2010 CARGILL ANIMAL NUTRITION

Total Records: 908

Due Date
2010-6300 08/17/2010 ORA/NE-FO/NWE-DO/NWECB/ SUE CARLSON CARGILL ANIMAL NUTRITION, SWANTON, VT - EIRS 4/19-
09/15/2010 CARGILL ANIMAL NUTRITION 26/10
2010-6301 08/17/2010 ORA/SW-FO/DAL- SUE CARLSON CARGILL ANIMAL NUTRITION, OKLAHOMA CITY, OK - EIR
09/15/2010 DO/COMPLIANCE/ CARGILL ANIMAL NUTRITION 4/20/10
2010-6302 08/17/2010 ORA/CE-FO/MIN-DO/MCB/ SUE CARLSON CARGILL LLANIMAL NUTRITION, BIG LAKE, MN - EIRS 4/14-
15/10
2010-6303 08/17/2010 ORA/CE-FO/CHI-DO/CCB/ SUE CARLSON CARGILL ANIMAL NUTRITION, FLORA, IL - EIR 3/24/10
2010-6304 08/17/2010 CDER/ORP/DIDP/ JEFFREY M GOODIS ESQ GENENTECH INC, SARAH CANNON RESEARCH INSTITUTE,
09/15/2010 CDER/ORP/DIDP/ THOMPSON GOODIS WESTERN IRG - GI-91 PROROCOL CLNCL TRIAL CMPLNTS,
VIOLATIONS, CORR, ETC; INDIVIDUAL RECS
2010-6305 08/17/2010 ORA/CE-FO/MIN-DO/MCB/ SUE CARLSON CARGILL ANIMAL NUTRITION, MILTON, WI - EIR 3/23/10
2010-6306 08/17/2010 ORA/SE-FO/FLA-DO/FCB/ SUE CARLSON CARGILL ANIMAL NUTRITION, AUBURNDALE, FL - EIR 3/9/10
2010-6307 08/17/2010 ORA/CE-FO/DET-DO/DCB/ DANIEL WEISER PERRIGO CO - WARNING LTR 4/29/10 STATUS
09/15/2010 MAGNETAR CAPITAL
2010-6308 08/17/2010 ORA/SW-FO/KAN-DO/COMP/ SUE CARLSON CARGILL INC, PURDY, MO - EIR 3/18/10
2010-6309 08/17/2010 ORA/SW-FO/KAN-DO/COMP/ SUE CARLSON CARGILL ANIMAL NUTRITION, MONTGOMERY CITY, MO -
EIR 3/11/10
2010-6310 08/17/2010 ORA/SW-FO/KAN-DO/COMP/ SUE CARLSON CARGILL INC, SMITHTON, MO - EIR 3/9/10
2010-6311 08/17/2010 ORA/CE-FO/MIN-DO/MCB/ CMPLNT 114921
09/15/2010 BARRIER, TERRY L
2010-6312 08/17/2010 CDRH/OMO/DEMO/FOIB/ LIANE LAROCHELLE MEDTRONIC INC - CARELINK PERSONAL THERAPY
MANAGEMENT SOFTWARE P980022/S073 RECS
09/15/2010 DEKA RESEARCH &
DEVELOPMENT CORP
2010-6313 08/17/2010 CDRH/OMO/DEMO/FOIB/ LIANE LA ROCHELLE MEDTRONIC INC - PARADIGM REAL-TIME PUMP
P980022/S069 RECS
09/15/2010 DEKA RESEARCH &
DEVELOPMENT CORP
2010-6314 08/17/2010 CDER/ORP/DIDP/ HAL LIPTON ESTEVE QUIMICA SA, CELRA, SPAIN - EIRS 7/5-8-10
09/15/2010 CDER/ORP/DIDP/ GYMA LABORATORIES OF
AMERICA INC
2010-6315 08/17/2010 CDER/ORP/DIDP/ HAL LIPTON OLON SPA, RODANO, ITALY - EIRS 5/3-7/10

Total Records: 908

Due Date
09/15/2010 CDER/ORP/DIDP/ GYMA LABORATORIES OF
AMERICA INC
2010-6316 08/17/2010 CDRH/OMO/DEMO/FOIB/ KIRK DAMMEYER NATURAL COMFORT DOUBLE ELECTRIC/BATTERY BREAST
PUMP K033131
09/15/2010 ARCADIS G & M OF MICHIGAN
LLC
2010-6317 08/17/2010 CDRH/OMO/DEMO/FOIB/ STACE GEFFNER-ATIYA C-MOR VISLAIZATION SYS - K093717
2010-6318 08/17/2010 CDER/ORP/DIDP/ CHRIS LAMB SPONSOR 3 SIGMA INC - IMMUNE GLOBULIN
09/15/2010 CDER/ORP/DIDP/ BIOSOLUTIONS SERVICES LLC INTRAVENOUS IND 7861 RECS
2010-6319 08/17/2010 CDER/ORP/DIDP/ BEN MCGINTY SPL RECS - 9/8/10 TO PRESENT

09/15/2010 CDER/ORP/DIDP/ REED TECHNOLOGY AND
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
2010-6320 08/17/2010 ORA/P-FO/SAN-DO/SFCB/ INTUITIVE SURGICAL INC, SUNNYVALE, CA - ALLOGENIC &
AUTOLOGOUS ISLET CELL TRANSPLANT APRVL RECS;
09/15/2010 O'BRIEN, DANIEL
483S 2004-2009, ETC
2010-6321 08/17/2010 CDER/ORP/DIDP/ STEVEN S HANAGAMI MINH FUNG GINSENG & TEA INC - EAGLE BRAND
09/15/2010 CDER/ORP/DIDP/ CHAN LAW GROUP LLP MEDICATED OIL IMPORT ALERT 66-13
2010-6322 08/17/2010 CDER/ORP/DIDP/ JAMES J PEPPER SEROQUEL, SEORQUEL XR, QUETIAPINE - AERS 1/97 TO
8/10
09/15/2010 CDER/ORP/DIDP/ ELLIOTT GREENLEAF
2010-6323 08/17/2010 CDER/ORP/DIDP/ M SCOTT SAMPLE SCANDINAVIAN GENE SYNTHESIS AB, KOPING, SWEDEN -
EIRS 2001 TO PRESENT
09/15/2010 CDER/ORP/DIDP/ SIGMA LIFE SCIENCE
2010-6324 08/17/2010 CDER/ORP/DIDP/ CHRISTOPHER J CONOSCENTI ABBOTT - DEPACON NDA 20-593 APRVL LTRS (CERTIFIED)
09/15/2010 CDER/ORP/DIDP/ VENABLE LLP
2010-6325 08/17/2010 ORA/NE-FO/NWE-DO/NWECB/ ROBERT L REEB BRISTOL SEAFOODS INC - RECONDITIONING PROTOCOL
FOR GOODS IN STORAGE AT AMERICOLD ON 1/22/10
09/15/2010 MARWEDEL MINICHELLO &
REEB PC
2010-6326 08/17/2010 CDER/ORP/DIDP/ HYDROCORTISONE ACETATE, ACIPHEX, ULTRAM, ETC -
09/15/2010 CDER/ORP/DIDP/ HENSLEY, DEBERA KAY AERS
2010-6327 08/17/2010 OM/OSS/OPILS/DFI/ CLOSED FOI REQUESTS 8/9-15/10


Total Records: 908

Due Date
2010-6333 08/17/2010 CDER/ORP/DIDP/ BILL PARTHUN SAGE PRODUCTS - CHLORHEXIDINE GLUCONATE
TOPICAL CLOTH NDA 21-669 APRVL TR, LBLG, RVWS, ETC
09/15/2010 CDER/ORP/DIDP/ MEDLINE INDUSTRIES INC
2010-6334 08/17/2010 OM/OSS/OPILS/DFI/ WARNING LTRS 8/10/10
2010-6335 08/18/2010 CDER/ORP/DIDP/ CHRISTINE M HUMPHREY ESQ NDA 20-714, NDA 17-771, NDA 20-372, ETC - RECS
09/16/2010 CDER/ORP/DIDP/ C HUMPHREY & ASSOCS PA
2010-6336 08/18/2010 ORA/P-FO/LOS-DO/LACB/ INGGRID DOTULONG LYCHEE, SOURSOP, MANGO, GUAVA - ENTRY #D52-
0937701 TEST RESULTS
09/16/2010 JANS ENTERPRISES
2010-6337 08/18/2010 ORA/CE-FO/NJ-DO/NJCB/ JEPH FILLON ENTRY #UY4-0034631-7 - ANALYTICAL W/S
09/16/2010 ORA/NE-FO/NYK-DO/NYDCB/ OMNI INTERNATIONAL LLC
2010-6338 08/18/2010 ORA/P-FO/LOS-DO/LACB/ LISA R TRENT EXOVA, SANTA FE SPRINGS, CA - EIR, 483 6/2-15/09
09/16/2010 SAFC PHARMA
2010-6339 08/18/2010 ORA/CE-FO/BLT-DO/CB/ SHARLENE EDMONDS PPD, RICHMOND, VA; MIDDLETON, WI - EIRS, 483S, CO
RESP 1/4-8/10
09/16/2010 ORA/CE-FO/MIN-DO/MCB/ PPD DEVELOPMENT
2010-6340 08/18/2010 CDER/ORP/DIDP/ KATHLEEN NOWOSIELSKI TEVA - THIOTEPA INJ ANDA 75-730 LBLG
09/16/2010 CDER/ORP/DIDP/ BEDFORD LABORATORIES
2010-6341 08/18/2010 CDER/ORP/DIDP/ LIST OF MARKETED UNAPPROVED DRUGS
09/16/2010 CDER/ORP/DIDP/ SIMARD, MICHELLE A
2010-6342 08/18/2010 CDER/ORP/DIDP/ TED MIERZWA DR KARL BAUM, HEMINGSDORF, GERMANY 5/3-7/10; DR
KRZYSTOF SELMAJ, LODZ, POLAND 5/4-7/10. 5/10/10; DR
09/16/2010 CDER/ORP/DIDP/ NOVARTIS PHARMACEUTICALS
CORP RUGGERO CAPRA, MONTICHIARI, ITALY 5/10-14/10 EIRS,
483S, CORR
2010-6343 08/18/2010 CDER/ORP/DIDP/ CHRISTOPHER BROOKS PHD ONTAK (DENILEUKIN DIFITOX) BLA 97-1325; ONCOLOGIC
DRUG A/C - MINS 1998, 1999
09/16/2010 CDER/ORP/DIDP/ STEMLINE THERAPEUTUCS INC
2010-6344 08/18/2010 CDER/ORP/DIDP/ DURAMED - PARAGARD NDA 18-680 RECS
09/16/2010 CDER/ORP/DIDP/ TREMBLEY, SCOTT
2010-6345 08/18/2010 CFSAN/OCD/EOS/ NORMAN A JACOBSON ALUMINUM HYDROXIDE POISONING - RECS
09/16/2010 ADVOCATES FOR SAFE FOOD

Total Records: 908

Due Date
AND MEDICINE INC
2010-6346 08/18/2010 CDER/ORP/DIDP/ MCNEIL - LEVAQUIN (LEVOFLOXACIN) AERS
09/16/2010 CDER/ORP/DIDP/ EDWARDS, S ALBERT
2010-6347 08/18/2010 CDER/ORP/DIDP/ NANITA CRANFORD PIRAMAL, ONTARIO, CANADA - EIRS, 483S, WARNING
09/16/2010 CDER/ORP/DIDP/ NEUROGESX INC LTRS, ETC
2010-6348 08/18/2010 ORA/SW-FO/KAN-DO/COMP/ UNIV HOSPITAL & CLINICS, COLULMBIA, MO - SINGLE USE
DVCS CMPLNTS
09/16/2010 Doe J
2010-6349 08/18/2010 CFSAN/OCD/EOS/ JOSEPH A ROSSI JR SPECIES LLC - LIPOLYZE, SOMALYZE THAT CONTAIN
09/16/2010 PIRROTTI LAW FIRM LLC USNIC ACID CAERS 117857
2010-6350 08/18/2010 CDER/ORP/DIDP/ MARTIN R PRINCE MD PHD GADOLINIUM - ISRS 6209727, 5823843, 5801388, ETC
09/16/2010 CDER/ORP/DIDP/ Weill Medical College of Cornell
University
2010-6351 08/18/2010 ORA/CE-FO/MIN-DO/MCB/ CMPLNT #115263
09/16/2010 Doe J
2010-6352 08/18/2010 CDRH/OMO/DEMO/FOIB/ ALAN J LANDERMAN ESQ SURGICAL MESH - ALERTS, CORR, CMPLNTS, ETC 10/21/08
09/16/2010 ALVAREZ SAMBOL WINTHROP &
MADSON PA
2010-6353 08/18/2010 CDRH/OMO/DEMO/FOIB/ ZOGENIC INC - SUMAVEL DOSEPRO MDRS
CDER/ORP/DIDP/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
2010-6354 08/18/2010 ORA/P-FO/LOS-DO/LACB/ WILL EVANS EFT BIOTECH HOLDINGS - EIR, 483, WARNING LTR RESP,
09/16/2010 CENTER FOR INVESTIGATIVE ETC 3/3/09
REPORTING
2010-6356 08/18/2010 CDRH/OMO/DEMO/FOIB/ AXIOM - SILICONE SOFT-PAK EPISTAXIS CATHETER
2010-6357 08/18/2010 CDRH/OMO/DEMO/FOIB/ CERVILENZ - UTERINE MEASURING SOUND K011840

2010-6358 08/18/2010 CDRH/OMO/DEMO/FOIB/ BL HEALTHCARE - REMOTE CARE MANAGEMENT SYS
2010-6359 08/18/2010 CDRH/OMO/DEMO/FOIB/ PHILIPS MEDICAL SYSTEMS - M3290A INTELLIVUE

Total Records: 908

Due Date
09/16/2010 FOI SERVICES INC INFORMATION CENTER SOFTWARE RELEASE E0 K023698
2010-6360 08/18/2010 CDRH/OMO/DEMO/FOIB/ PHILIPS MEDICAL SYSTEMS - M3290A INTELLIVUE
09/16/2010 FOI SERVICES INC INFORMATION CENTER SOFTWARE RELEASE E.01 &
INTELLIVUE CLNCL NETWORK ON VLAN K040955
2010-6361 08/18/2010 CDRH/OMO/DEMO/FOIB/ HUBER NEEDLES - PERFORMANCE, TESTING, STATUS
RECS 2009-2010
2010-6362 08/18/2010 CDRH/OMO/DEMO/FOIB/ MARGE WALLS-WALKER INSTENT ESOPHACOIL SELF-EXPANDING STENT SYS -
K955041
09/16/2010 COOK ENDOSCOPY
2010-6363 08/18/2010 CDRH/OMO/DEMO/FOIB/ MARGE WALLS-WALKER INSTENT ESOPHACOIL ESOPHAGEAL PROSTHESIS -
09/16/2010 COOK ENDOSCOPY K941487
2010-6364 08/18/2010 CDRH/OMO/DEMO/FOIB/ SANJIV KUMAR DR JAPAN FACIL POINT SPINAL NEEDLE - K020934
09/16/2010 MYCO MEDICAL
2010-6365 08/18/2010 CDRH/OMO/DEMO/FOIB/ ANDREW WHELAN MCII MODEL 72005 - K903161
09/16/2010 BIOELECTRONICS
2010-6366 08/18/2010 ORA/CE-FO/CHI-DO/CCB/ MONICA ENGEBRETSON CZIMER'S GAME & SEA FOODS, HOMER GLENN, IL - EIRS,
09/16/2010 BORN FREE USA SHIPPING RECS 1/09 TO PRESENT
2010-6367 08/18/2010 CDER/ORP/DIDP/ COLEEN KLASMEIER 510KS FOR PRODUCT CODES NBW, CGA, CFR, LFR 8/09 TO
09/16/2010 CDER/ORP/DIDP/ SIDLEY AUSTIN LLP PRESENT
CDRH/OMO/DEMO/FOIB/
2010-6368 08/18/2010 CDRH/OMO/DEMO/FOIB/ STACIE GEFFNER-ATIYA C-MOR VISUALIZATION SYS - K09317; SMITH & NEPHEW -
VIDEOARTHROSCOPE K043395; S&N - VIDEO
ARTHROSCOPE K082293
2010-6369 08/19/2010 CFSAN/OCD/EOS/ REBECCA HENDERSON REGULATIONS THAT SPECIFY THAT SOYA BASED INFANT
09/17/2010 VEGAN SOCIETY FORMULA MUST BE FORTIFIED WITH D3
2010-6370 08/19/2010 CDRH/OMO/DEMO/FOIB/ KEVIN M MADAGAN INO THERAPEUTICS/IKARIA - INOMAX DS DELIVERY SYS
K093922
09/17/2010 REED SMITH LLP
2010-6371 08/19/2010 ORA/ORO/DIOP/ DONALD N BLUE IMPORT REFUSALS 1/10 TO 7/10
09/17/2010 ZETETIC
2010-6372 08/19/2010 CDRH/OMO/DEMO/FOIB/ ALEX CZARRECKI MEDTRONIC - PRESTIGE CERVICAL DISC SYS IDE
09/17/2010 MEDICAL COLLEGE OF G010188, BRYAN CERVICAL DISC IDE G00123
WISCONSIN
2010-6373 08/19/2010 ORA/ MARK G MAZZIE EDUNEERING INC - TRANSITIONING FDA BASIC LAW
09/17/2010 ORA/ORM/ CENTER FOR PROFESSIONAL COURSE TO ON-LINE LEARNING
INNOVATION & EDUCATION INC
2010-6374 08/19/2010 CBER/OCTMA/DDOM/ALFB/ MARILYN CARDONA INDIVIDUAL RECS

Total Records: 908

Due Date
09/17/2010 MCS
2010-6375 08/19/2010 ORA/SE-FO/NOL-DO/NOCB/ TOMOKO KANEDA ENTRY #112-76837758 - LAB ANALYSIS
09/17/2010 HCT PACKAGING
2010-6376 08/19/2010 ORA/SE-FO/ATL-DO/ACB/ NANITA CRANFORD CIRRUS PHARMACEUTICALS INC, DURHAM, NC - EIRS,
09/17/2010 NEUROGESX INC 483S, WARNING LTRS, ETC 1/06 TO PRESENT
2010-6377 08/19/2010 CBER/OCTMA/DDOM/ALFB/ CHELSEY D SLAPE VAERS - INDIVIDUAL RECS

09/17/2010 SANDBERG PHOENIX & VON
GONTARD
2010-6378 08/19/2010 CFSAN/OCD/EOS/ NANCY MILLER 1-ETHYNYL-1CYCLOHEXANOL - FCN 701, FCN 924;
PHTHALIMIDOMETHYL COPPER PHTHALOCYANINE - FCN
09/17/2010 NSF International
966
2010-6379 08/19/2010 CDER/ORP/DIDP/ CISSY HILBERT NIDPOE LTR 4/13/01
09/17/2010 CDER/ORP/DIDP/ Jones, Walker, Waechter,
Poitevent, Carrere & Denegre
L.L.P.
2010-6380 08/19/2010 CFSAN/OCD/EOS/ JOANNE HAWANA ALOE VERA JUICE - CAERS
09/17/2010 ARENT FOX LLP
2010-6381 08/19/2010 CDER/ORP/DIDP/ JOANNE HAWANA FOREVER LIVING PRODUCTS INTERNATIONAL INC - FOOD,
09/17/2010 CDER/ORP/DIDP/ ARENT FOX LLP BEVERAGES, DIETARY SUPPLEMENTS, ETC CAERS, AERS
CFSAN/OCD/EOS/
2010-6382 08/19/2010 CDER/ORP/DIDP/ JOANNE HAWANA ALOE VERA OF AMERICA INC - FOOD, BEVERAGES,
09/17/2010 CDER/ORP/DIDP/ ARENT FOX LLP DIETARY SUPPLEMENTS, ETC CAERS, AERS
CFSAN/OCD/EOS/
2010-6383 08/20/2010 ORA/P-FO/SAN-DO/SFCB/ VIRGINIA SMITH MEDCOMM SOLUTION, EMERYVILLE, CA - EIRS, 483S, CO
RESPS 10/09 TO 7/10
2010-6384 08/20/2010 ORA/CE-FO/BLT-DO/CB/ VIRGINIA SMITH NEXT BREATH LLC, BALTIMORE, MD - EIRS, 483S, CO
09/20/2010 KENDLE REGULATORY AFFAIRS RESPS 10/09 TO 7/10
2010-6385 08/20/2010 ORA/NE-FO/NYK-DO/NYDCB/ VIRGINIA SMITH NORWICH PHARMACEUTICALS INC, NORWICH, NY - EIRS,
09/20/2010 KENDLE REGULATORY AFFAIRS 483S, CO RESPS 10/09 TO 7/10
2010-6386 08/20/2010 ORA/CE-FO/MIN-DO/MCB/ VIRGINIA SMITH PACE ANALYTICAL LIFE SCIENCES LLC, OAKDALE, MN -
EIRS, 483S, CO RESPS 10/09 TO 7/10
2010-6387 08/20/2010 ORA/CE-FO/DET-DO/DCB/ VIRGINIA SMITH PFIZER INC, KALAMAZOO, MI - EIRS, 483S, CO RESPS 10/09
09/20/2010 KENDLE REGULATORY AFFAIRS TO 7/10
2010-6388 08/20/2010 ORA/CE-FO/BLT-DO/CB/ VIRGINIA SMITH PHARMACETUICS INTERNATIONAL INC, HUNT VALLEY, MD
09/20/2010 KENDLE REGULATORY AFFAIRS - EIRS, 483S, CO RESPS 10/09 TO 7/10

Total Records: 908

Due Date
2010-6389 08/20/2010 ORA/CE-FO/NJ-DO/NJCB/ VIRGINIA SMITH PHARMAGISTICS LLC, SOMERSET, NJ - EIRS, 483S, CO
09/20/2010 KENDLE REGULATORY AFFAIRS RESPS 10/09 TO 7/10
2010-6390 08/20/2010 ORA/SW-FO/KAN-DO/COMP/ VIRGINIA SMITH UNIV OF IOWA (PHARMACETUICAL SERVICES DIV,
09/20/2010 KENDLE REGULATORY AFFAIRS COLLEGE OF PHARMACY), IOWA CITY, IA - EIRS, 483S, CO
RESPS 10/09 TO 7/10
2010-6391 08/20/2010 ORA/CE-FO/CIN-DO/CCB/ VIRGINIA SMITH UPS SUPPLY CHAIN SOLUTIONS, LOUISVILLE, KY - EIRS,
483S, CO RESPS 10/09 TO 7/10
2010-6392 08/20/2010 ORA/P-FO/SAN-DO/SFCB/ VIRGINIA SMITH UPS SUPPLY CHAIN SOLUTIONS (UNIT C & D), RENO, NV -
09/20/2010 KENDLE REGULATORY AFFAIRS EIRS, 483S, CO RESPS 10/09 TO 7/10
2010-6393 08/20/2010 ORA/CE-FO/CIN-DO/CCB/ VIRGINIA SMITH WEST ANALYTICAL SERVICES LLC, MAUMEE, OH - EIRS,
2010-6394 08/20/2010 CDER/ORP/DIDP/ LINDA BROWN ARAVA (LEFLUNOMIDE) - ISRS 3927433, 4233561, 4248996,
ETC
09/20/2010 CDER/ORP/DIDP/ SANOFI AVENTIS
2010-6395 08/20/2010 ORA/P-FO/LOS-DO/LACB/ VIRGINIA SMITH 3M PHARMS (3M DRUG DELIVERY SYSTEMS DIV),
NORTHRIDGE, CA - EIRS, 483S, CO RESPS 10/09 TO 7/10
2010-6396 08/20/2010 ORA/CE-FO/CHI-DO/CCB/ VIRGINIA SMITH CATALENT PHARMA SOLUTIONS (CARDINAL HEALTH
09/20/2010 KENDLE REGULATORY AFFAIRS PACKAGING SERVICES, STERILE TECHNOLOGIES),
WOODSTOCK, IL - EIRS, 483S, CO RESPS 10/09 TO 7/10
2010-6397 08/20/2010 CDER/ORP/DIDP/ LINDA BOWEN NIDPOE LTRS - 5/10 TO PRESENT
09/20/2010 CDER/ORP/DIDP/ SANOFI AVENTIS
2010-6398 08/20/2010 ORA/SW-FO/KAN-DO/COMP/ VIRGINIA SMITH ABC LABS, COLUMBIA, MO - EIRS, 483S, CO RESPS 10/09
TO 7/10
2010-6399 08/20/2010 ORA/CE-FO/DET-DO/DCB/ VIRGINIA SMITH DOW CHEMICAL CO, MIDLAND, MI - EIRS, 483S, CO RESPS
09/20/2010 KENDLE REGULATORY AFFAIRS 10/09 TO 7/10
2010-6400 08/20/2010 ORA/SE-FO/ATL-DO/ACB/ VIRGINIA SMITH HOLOPACK, COLUMBIA, SC - EIRS, 483S, CO RESPS 10/09
TO 7/10
2010-6401 08/20/2010 ORA/CE-FO/CIN-DO/CCB/ VIRGINIA SMITH PATHEON, CINCINNATI, OH - EIRS, 483S, CO RESPS 10/09
TO 7/10
2010-6402 08/20/2010 CDER/ORP/DIDP/ PATRICIA L REGENYE JANUSZ ROLISKI, KLINIKA CHEMIOTERAPII CTR ONKOLO
09/20/2010 CDER/ORP/DIDP/ Celgene Corporation INSTYTUT IM, KRAKOW, POLAND - EIRS, 483S, CORR 5/09
TO PRESENT
2010-6403 08/20/2010 ORA/CE-FO/MIN-DO/MCB/ VIRGINIA SMITH PPD LABS, MIDDLETON, WI - EIRS, 483S, CO RESPS 10/09
TO 7/10
2010-6404 08/20/2010 ORA/SE-FO/SJN-DO/SJCB/ VIRGINIA SMITH PATHEON (MOVA PHARMACEUTICAL CORP), MANATI, PR -
EIRS, 483S, CO RESPS 10/09 TO 7/10

Total Records: 908

Due Date
2010-6405 08/20/2010 CDER/ORP/DIDP/ PATRICIA L REGENYE PAUL O'CONNOR, ST MICHAELS HOSP ( UNIV OF
09/20/2010 CDER/ORP/DIDP/ Celgene Corporation TORONTO), TORONTO, CANADA - EIRS, 483S, CORR 4/01
TO PRESENT
CDER/ORP/DIDP/
CDER/ORP/DIDP/
2010-6406 08/20/2010 ORA/CE-FO/PHI-DO/PCB/ VIRGINIA SMITH ALMAC CLINICAL SERVICES, AUDUBON, PA - EIRS, 483S,
CO RESPS 10/09 TO 7/10
2010-6407 08/20/2010 CDER/ORP/DIDP/ PATRICIA L REGENYE MARY O'BRIEN, ROYAL MARSDEN HOSP, SUTTON, UK -
09/20/2010 CDER/ORP/DIDP/ Celgene Corporation EIRS, 483S, CORR 9/07 TO PRESENT
2010-6408 08/20/2010 ORA/SW-FO/KAN-DO/COMP/ VIRGINIA SMITH CELSIS LABORATORY GROUP, ST LOUIS, MO - EIRS, 483S,
2010-6409 08/20/2010 ORA/CE-FO/NJ-DO/NJCB/ VIRGINIA SMITH J KNIPPER & COMPANY INC, LAKEWOOD, NJ - EIRS, 483S,
2010-6410 08/20/2010 ORA/CE-FO/PHI-DO/PCB/ VIRGINIA SMITH LANCASTER LABORATORIES, LANCASTER, PA - EIRS,
2010-6411 08/20/2010 CDER/ORP/DIDP/ JODY L GREEN ISRS 6383990-X, 6491489-5, 6527491-4, ETC
09/20/2010 CDER/ORP/DIDP/ ROCKEY MOUNTAIN POISON &
DRUG CTR
2010-6412 08/20/2010 ORA/SW-FO/DAL- PATRICIA L REGENYE TERRY JONES (JS STUDIES), BRYAN, TX - EIR, 483, CORR,
09/20/2010 DO/COMPLIANCE/ Celgene Corporation CO RESP 9/96 TO PRESENT
2010-6413 08/20/2010 ORA/CE-FO/PHI-DO/PCB/ PATRICIA L REGENYE ATHANASSIOS ARGIRIS (UPMC CANCER PAVILION),
PITTSBURGH, PA - EIR, 483, CORR, CO RESP 6/09 TO
09/20/2010 Celgene Corporation
PRESENT
2010-6414 08/20/2010 ORA/SE-FO/ATL-DO/ACB/ PATRICIA L REGENYE JONATHAN WEISS (GWINNETT CLINICAL RESEARCH
09/20/2010 Celgene Corporation CENTER INC) SNELLVILLE, GA - EIR, 483, CORR, CO RESP
12/99 TO PRESENT
2010-6415 08/20/2010 ORA/SW-FO/DAL- PATRICIA L REGENYE MICHAEL JARRATT (DERMRESEARCH), AUSTIN, TX - EIR,
09/20/2010 DO/COMPLIANCE/ Celgene Corporation 483, CORR, CO RESP 12/82 TO PRESENT
2010-6416 08/20/2010 ORA/CE-FO/DET-DO/DCB/ PATRICIA L REGENYE CHRISTOPHER GRIFFITHS (UNIV MICHAGAN MED CTR),
ANN ARBOR, MI - EIR, 483, CORR, CO RESP 9/92 TO
PRESENT
2010-6417 08/20/2010 ORA/CE-FO/PHI-DO/PCB/ PATRICIA L REGENYE PREMIER RESEARCH GROUP, PHILADELPHIA, PA - EIR,
09/20/2010 Celgene Corporation 483, CORR, CO RESP 1/03 TO PRESENT
2010-6418 08/20/2010 ORA/P-FO/SEA-DO/SCB/ PATRICIA L REGENYE DONALD SHERRARD (VA HOSPITAL), SEATTLE, WA - EIR,
483, CORR, CO RESP 12/78 TO PRESENT

Total Records: 908

Due Date
2010-6419 08/20/2010 ORA/NE-FO/NYK-DO/NYDCB/ PATRICIA L REGENYE JOHN CONDEMI (ALLERY ASTHMA IMMUNOLOGY
09/20/2010 Celgene Corporation ROCHESTER), ROCHESTER, NY - EIR, 483, CORR, CO RESP
5/86 TO PRESENT
2010-6420 08/20/2010 ORA/P-FO/SEA-DO/SCB/ PATRICIA L REGENYE DENNIS BOURDETTE (OREGON HEALTH SCIENCES UNIV),
PORTLAND, OR - EIR, 483, CORR, CO RESP 2/96 TO
PRESENT
2010-6421 08/20/2010 ORA/SW-FO/DEN-DO/COMP/ PATRICIA L REGENYE DAVID COLLIER (UNIV COLORADO HEALTH SCIENCE
09/20/2010 Celgene Corporation CENTER), DENVER, CO - EIR, 483, CORR, CO RESP 4/04 TO
PRESENT
2010-6422 08/20/2010 ORA/SW-FO/DAL- ELIZABETH WOECKNER STANISLAW R BURZYNSKI MD (BURZYNSKI RESEARCH
DO/COMPLIANCE/ INSTITUTE), HOUSTON, TX -EIR, 483, CORR, CO RESP
09/20/2010 CITIZENS FOR RESPONSIBLE
CARE & RESEARCH 8/6/01
2010-6423 08/20/2010 ORA/SW-FO/DAL- ELIZABETH WOECKNER BURZYNSKI RESEARCH INSTITUTE, HOUSTON, TX -EIR,
09/20/2010 DO/COMPLIANCE/ CITIZENS FOR RESPONSIBLE 483, CO RESP 2/12-15/02
OM/OSS/OPILS/DFI/ CARE & RESEARCH
OM/OSS/OPILS/DFI/
2010-6424 08/20/2010 ORA/SE-FO/ATL-DO/ACB/ DOLLY BURNETT NORTHSIDE WOMEN'S IMAGING SERVICES, ALPHARETTA,
GA - ANNUAL INSP 2006 TO 2008
09/20/2010 POPE & HOWARD PC
2010-6425 08/20/2010 ORA/NE-FO/NYK-DO/NYDCB/ MIRANDA NELSON MOTT'S LLP, WILLIAMS, NY - INSP, RESULT & LAB TESING
1/06 TO PRESENT
09/20/2010 UNITED FOOD & COMMERCIAL
WORKERS INTERNATIONAL
UNION
2010-6426 08/20/2010 ORA/SW-FO/DAL- CHRISTOPHER FINDELL SPL #620604, #569083
09/20/2010 DO/COMPLIANCE/ SPECTRUM JUNGLE LABS CORP
ORA/SW-FO/DAL-
DO/COMPLIANCE/
2010-6427 08/20/2010 ORA/NE-FO/NYK-DO/NYDCB/ BRUCE H STERN PET, NEW YORK, NY - EIR 6/08, WARNING LTR, 2004 INSP
09/20/2010 STARK & STARK RECS, ETC
2010-6428 08/20/2010 CDER/ORP/DIDP/ TEVA PHARMACEUTICALS USA, PERRIGO CO -

09/20/2010 CDER/ORP/DIDP/ ROSENTHAL, AMIR LORATADINE ANDA 75-505 RECS
2010-6429 08/20/2010 CDER/ORP/DIDP/ JAZIEL SOTOMAYOR APOTEX INC, TORONTO; WESTON; RICHMOND HILL;
ONTARIO, CANADA - INPS, RPTS, CORR, ETC
09/20/2010 CDER/ORP/DIDP/ HEALTH CANADA
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
2010-6430 08/20/2010 CDER/ORP/DIDP/ AMANDA WEHLER DO GENZYME - MOZOBIL TRIAL 31010-LTF, 3102-LTF ANNUAL

Total Records: 908

Due Date
09/20/2010 CDER/ORP/DIDP/ GEISINGER HEALTH SYSTEM RPT
2010-6431 08/20/2010 ORA/ SCOTT S LIEBMAN PRESCRIPTION DRUG MARKETING ACT (PDMA) INSPS 2000
09/20/2010 PORZIO PHARMACEUTICAL TO PRESENT
SERVICES LLC
2010-6432 08/20/2010 CDER/ORP/DIDP/ T CAREY WICKER III TEVA PHARMACEUTICALS USA, IVAX CORP, AR
09/20/2010 CDER/ORP/DIDP/ CAPITELLI & WICKER SCIENTIFIC, ETC - QUININE SULFATE CORR, SUBMISSIONS
7/31/06-1/1/07
2010-6433 08/20/2010 ORA/SW-FO/KAN-DO/COMP/ ROBERT G NORFLEET FOUNDATION CARE PHARMACY, EARTH CITY, MO - EIR
8/9-27/07, CMPLNT 54344, WARNING LTR 1/4/08, ETC
09/20/2010 NORTON & NORTON
2010-6434 08/20/2010 CFSAN/OCD/EOS/ WILLIAM A OLSON PHD POLYGLYCOLIC ACID - FCN 958
09/20/2010 Center for Regulatory Services, Inc.
2010-6435 08/20/2010 ORA/ PAULE BELONY DIETARY SUPPLEMENT INSPS 6/09 TO 5/10
09/20/2010 BELONY GROUP LLC
2010-6436 08/20/2010 CDER/ORP/DIDP/ MICHAEL J FLANNERY GLAXOSMITHKLINE CONSUMER HEALTHCARE - ALLI NDA
09/20/2010 CDER/ORP/DIDP/ CAREY & DANIS LLC 21-887 LBLG, AERS, CORR, ETC
2010-6437 08/20/2010 ORA/CE-FO/CIN-DO/CCB/ CMPLNT #115432

09/20/2010 Doe J
2010-6438 08/20/2010 CDRH/OMO/DEMO/FOIB/ RICHARD S COPELAND CHATTEM INC - EXTRA STRENGTH ICY HOT MEDICATED
09/20/2010 ORA/SE-FO/NOL-DO/NOCB/ MORENO & PEREZ PATCH CMPLNTS, WARNINGS, LBLG, ETC
2010-6439 08/20/2010 CTP/OD/ RICHARD G HIGBY PHD TOBACCO PRODUCTS - BRNADS REGISTERED WITH FDA
09/20/2010 CTP/OD/ ARISTA LABORATORIES
2010-6440 08/20/2010 CFSAN/OCD/EOS/ E N NOWAK INVISTA SARL - 1,4-BENZENEDICARBOXYLIC ACID FCN 967
09/20/2010 M&G POLYMERS USA LLC
2010-6441 08/20/2010 ORA/SW-FO/KAN-DO/COMP/ BRIAN HARTMAN WRIGHT COUNTY EGG, GALT, IA - ISNPS LAST 5 YRS
09/20/2010 ABC NEWS, INC.
2010-6442 08/20/2010 ORA/SW-FO/DEN-DO/COMP/ BAXA CORP - EXACTA-MIX 2400 RECALL 6/27/07, WARNING
09/20/2010 JOHNS, THOMAS LTR 1/14/08
2010-6443 08/20/2010 CDRH/OMO/DEMO/FOIB/ DENALI CORP - AURAVUE PIT & FISSUE SEALANT K070693
09/20/2010 SETH H SALINGER
2010-6444 08/20/2010 CDRH/OMO/DEMO/FOIB/ DENALI CORP - FUSION RESIN CEMENT & CORE KIT
K070702
09/20/2010 SETH H SALINGER
2010-6445 08/20/2010 CDRH/OMO/DEMO/FOIB/ DENALI CORP - AURALAY PIT & FISSURE SEALANT
09/20/2010 SETH H SALINGER K071158
2010-6446 08/20/2010 CDRH/OMO/DEMO/FOIB/ MARGE WALLS-WALKER INSTENT ESOPHACOIL ESOPHAGEAL PROSTHESISI

Total Records: 908

Due Date
2010-6448 08/20/2010 CDRH/OMO/DEMO/FOIB/ MARGE WALLS-WALKER INSTENT ESOPHACOIL SELF-EXPANDING STEN SYS

2010-6450 08/20/2010 OM/OSS/OPILS/DFI/ GLADYS B TONKIN FOI DAILY LOG 8/9-13/10
2010-6451 08/20/2010 CFSAN/OCD/EOS/ JEFF DONN RADIONUCLIDES IN FOOD-IMPORT & DOMESTIC - RECS
09/20/2010 ORA/ ASSOCIATED PRESS
ORA/ORO/DFS/
2010-6452 08/20/2010 OM/OSS/OPILS/DFI/ KENNETH REID FOI DAILY LOG 8/9-13/10
SOURCE
2010-6453 08/20/2010 OM/OSS/OPILS/DFI/ LIST OF DRUGS MARKETED IN THE US NOT APRVD BY FDA
09/20/2010 OM/OSS/OPILS/DFI/ TREPANIER, ERIC
2010-6454 08/20/2010 OM/OSS/OPILS/DFI/ DEBI COHEN FOI DAILY LOG 8/9-13/10
BUSINESS
2010-6455 08/20/2010 OM/OSS/OPILS/DFI/ FOI DAILY LOG 1/09 TO 12/09
2010-6456 08/20/2010 OM/OSS/OPILS/DFI/ CECELIA FRENCH FOI DAILY LOG 8/9-13/10
2010-6457 08/20/2010 ORA/NE-FO/NWE-DO/NWECB/ ROBERT P GIACALONE R PH SHARMROCK MEDICAL SOLUTION GROUP INC, EAST
TAUNTON, MA - EIRS, 483S, CO RESPS, CORR, ETC 7/09 TO
09/20/2010 CARDINAL HEALTH
PRESENT
2010-6458 08/20/2010 CBER/OCTMA/DDOM/ALFB/ SANOFI PASTEUR - INFLUENZA SEASONAL FLUZONE
VAERS
09/20/2010 Doe J
2010-6459 08/20/2010 CDER/ORP/DIDP/ STEVAN A GREENBERG EFFECT OF A T-CELL DEPLETING MONOCLONAL
09/20/2010 CDER/ORP/DIDP/ BRIGHAM & WOMEN'S HOSPITAL ANTIBODY, ALEMTUZUMAB, IN PATIENTS W/INCLUSION
BODY MYOSITIS: A PILOT CLINICOPATHOLOGICAL STUDY;
SAFETY, TOLERABILIITY AND EFFICACY OF RITUXIMAB IN
PATIENTS WITH IGM ANTI-GLYCOCONJUGATE ANTIBODY
MEDIATED DEMYELINATING NEUROPATHY: A DOUBLE
BLIND PLACEBO CONTROLLED RANDOMIZED TRIAL - NIH

Total Records: 908

Due Date
PROTOCOLS
2010-6460 08/20/2010 CDER/ORP/DIDP/ KATE PURCELL FISH OILS - DMF 7436
09/20/2010 CDER/ORP/DIDP/ DOCUTRIEVAL INFORMATION
SERVICES
2010-6461 08/20/2010 CDER/ORP/DIDP/ KATE PURCELL N-3 FATTY ACID ETHYLESTERS - DMF 7779
09/20/2010 CDER/ORP/DIDP/ DOCUTRIEVAL INFORMATION
SERVICES
2010-6462 08/20/2010 CDER/ORP/DIDP/ VIRGINIA SMITH BAYER HEALTHCARE - STAXYN (VARDENAFIL) NDA 20-179
09/20/2010 CDER/ORP/DIDP/ KENDLE REGULATORY AFFAIRS APRVL LTR, LBLG, RVWS ETC
2010-6463 08/20/2010 CDER/ORP/DIDP/ VIRGINIA SMITH PURDUE PHAARMA - DISCONTINUATION OF OXYCONTIN

09/20/2010 CDER/ORP/DIDP/ KENDLE REGULATORY AFFAIRS NDA 22-272 RECS
2010-6464 08/20/2010 CDER/ORP/DIDP/ VIRGINIA SMITH WATSON LABS - NORCO ANDA 40-099 APRVL LTR, LBLG,
RVWS, ETC
2010-6465 08/20/2010 CDER/ORP/DIDP/ VIRGINIA SMITH WATSON LABS - NORCO ANDA 40-148 APRVL LTR, LBLG,
RVWS, ETC
2010-6466 08/20/2010 CDER/ORP/DIDP/ VIRGINIA SMITH PATHEON, MISSISSAUGA, ONTARIO, CANADA - EIRS, 483S,
09/20/2010 CDER/ORP/DIDP/ KENDLE REGULATORY AFFAIRS CO RESP 10/1/09 TO PRESENT
2010-6467 08/20/2010 CDER/ORP/DIDP/ VIRGINIA SMITH AEROCAN FRANCE SAS (FORMERLY, ALCAN CEBAL
AEROSOLS), BELLEGARDE, FRANCE - EIRS, 483S, CO
RESP 10/1/09 TO PRESENT
2010-6468 08/20/2010 CDER/ORP/DIDP/ VIRGINIA SMITH BESPAK EUROPE LTD, NORFOLK, ENGLAND - EIRS, 483S,
CO RESP 10/1/09 TO PRESENT
2010-6469 08/20/2010 CDER/ORP/DIDP/ VIRGINIA SMITH SHASUN PHARMA SOLUTIONS (FORMERLY RHODIA
09/20/2010 CDER/ORP/DIDP/ KENDLE REGULATORY AFFAIRS PHARMA SOLUTIONS), NORTHUMBERLAND, ENGLAND -
EIRS, 483S, CO RESP 10/1/09 TO PRESENT
2010-6470 08/20/2010 CDER/ORP/DIDP/ VIRGINIA SMITH 3M HEALTH CARE LT, LOUGBOROUGH, LEICESTERSHIRE,
UK - EIRS, 483S, CO RESP 10/1/09 TO PRESENT
CDER/ORP/DIDP/
CDER/ORP/DIDP/
2010-6471 08/20/2010 CDER/ORP/DIDP/ VIRGINIA SMITH NYCOMED GMBH, SINGEN, GERMANY - EIRS, 483S, CO
09/20/2010 CDER/ORP/DIDP/ KENDLE REGULATORY AFFAIRS RESP 10/1/09 TO PRESENT
2010-6472 08/20/2010 CDER/ORP/DIDP/ VIRGINIA SMITH DYNAMIT NOBEL GMBH, KALKSTRASSE, LEVERKUSEN,
GERMANY - EIRS, 483S, CO RESP 10/1/09 TO PRESENT
2010-6473 08/20/2010 CDER/ORP/DIDP/ VIRGINIA SMITH LABOR L&S AG, BAD BOCKLET-GROSSENBRACH,

Total Records: 908

Due Date
09/20/2010 CDER/ORP/DIDP/ KENDLE REGULATORY AFFAIRS GERMANY - EIRS, 483S, CO RESP 10/1/09 TO PRESENT
2010-6474 08/20/2010 CDER/ORP/DIDP/ VIRGINIA SMITH MICRONISIERUNGS-KONTOR OBERROT GMBH (MCKO),
09/20/2010 CDER/ORP/DIDP/ KENDLE REGULATORY AFFAIRS OBERROT, GERMANY - EIRS, 483S, CO RESP 1/1/09 TO
PRESENT
2010-6475 08/20/2010 CDER/ORP/DIDP/ VIRGINIA SMITH PATHEON INC, BOURGOIN-JALLIEU, CEDEX, FRANCE -
EIRS, 483S, CO RESP 10/1/09 TO PRESENT
2010-6476 08/20/2010 CDER/ORP/DIDP/ VIRGINIA SMITH PATHEON INC, BURLINGTON, ONTARIO, CANADA - EIRS,
483S, CO RESP 10/1/09 TO PRESENT
2010-6477 08/20/2010 CDER/ORP/DIDP/ VIRGINIA SMITH PATHEON INC, WHITBY, ONTARIO,CANADA - EIKRS, 483S,
09/20/2010 CDER/ORP/DIDP/ KENDLE REGULATORY AFFAIRS CO RESP 10/1/09 TO PRESENT
2010-6478 08/20/2010 CDER/ORP/DIDP/ WILLIAM G GAINER TYLENOL EXTRA STRENGTH CAPS NDA 17-053 - CLNCL
TRIALS, TEST RESULTS, LBLG, ETC
09/20/2010 CDER/ORP/DIDP/ TOLIVER & GAINER
2010-6479 08/20/2010 CDER/ORP/DIDP/ PHOTOGRAPHY & IMAGE PROCESSING OF PRESCRIPTION
SOLID DOSAGE FORM MEDICATIONS - INTERAGENCY
09/20/2010 CDER/ORP/DIDP/ PERILLAN, PABLO R
AGREEMENT, ADDENDUMS, MODIFICATIONS, ETC
2010-6480 08/23/2010 CBER/OCTMA/DDOM/ALFB/ WALTER E CHALKLEY GLAXOSMITHKLINE BIOLOGICALS, WAVRE, BELGIUM -
09/21/2010 THOMSON REUTERS EIRS, 483S, CO RESP 2009, 2010
2010-6481 08/23/2010 CBER/OCTMA/DDOM/ALFB/ WALTER E CHALKLEY HAW PAR HEALTHCARE LTD, SINGAPORE - EIRS, 483S CO
RESP 10/26-29/09
09/21/2010 CDER/ORP/DIDP/ THOMSON REUTERS
CDER/ORP/DIDP/
2010-6482 08/23/2010 ORA/SE-FO/FLA-DO/FCB/ WALTER E CHALKLEY SCULLY SEAN MD (UNIV OF MIAMI HOSPITAL), MIAMI, FL -
EIRS, 483S, CO RESP 3/15/10 TO 4/15/10
2010-6483 08/23/2010 ORA/CE-FO/NJ-DO/NJCB/ WALTER E CHALKLEY COREPHARMA, MIDDLESEX, NJ - EIRS, 483S, CO RESP
09/21/2010 THOMSON REUTERS 11/24/09 TO 1/20/10
2010-6484 08/23/2010 ORA/CE-FO/DET-DO/DCB/ WALTER E CHALKLEY PIONEER SURGICAL TECHNOLOGY, MARQUETTE, MI -

EIRS, 483S, CO RESP 4/19-22/10
2010-6485 08/23/2010 ORA/P-FO/SEA-DO/SCB/ WALTER E CHALKLEY NITROX INC, LYNNWOOD, WA - EIRS, 483S, CO RESP
3/22/10 TO 4/19/10
2010-6486 08/23/2010 CBER/OCTMA/DDOM/ALFB/ WALTER E CHALKLEY GLAXOSMITHKLINE BIOLOGICALS, RIXENSART, BELGIUM -
09/21/2010 THOMSON REUTERS EIRS, 483S, CO RESP 2009 TO 2010
2010-6487 08/23/2010 ORA/P-FO/LOS-DO/LACB/ MIRANDA NELSON THE AMERICAN BOTTLING CO, BUENA PARK,
09/21/2010 ORA/P-FO/SAN-DO/SFCB/ UNITED FOOD & COMMERCIAL SACRAMENTO, VERNON, VICTORVILLE, CA - 483S 1/06 TO
WORKERS INTERNATIONAL PRESENT
UNION
2010-6488 08/23/2010 ORA/CE-FO/PHI-DO/PCB/ MIRANDA NELSON MOTT'S LLP, ASPERS, PA - 483S 1/06 TO PRESENT

Total Records: 908

Due Date
UNION
2010-6489 08/23/2010 ORA/CE-FO/CIN-DO/CCB/ MIRANDA NELSON THE AMERICAN BOTTLING CO, IRVING, HOUSTON, SAN
09/21/2010 ORA/SW-FO/DAL- UNITED FOOD & COMMERCIAL ANTONIO TX; COLUMBUS, OH - 483S 1/06 TO PRESENT
DO/COMPLIANCE/ WORKERS INTERNATIONAL
UNION
2010-6490 08/23/2010 ORA/NE-FO/NYK-DO/NYDCB/ MIRANDA NELSON MOTT'S LLP, WILLIAMSON, NY - 483S 1/06 TO PRESENT
UNION
2010-6491 08/23/2010 ORA/CE-FO/NJ-DO/NJCB/ MIRANDA NELSON MOTT'S LLP, CARTERET, NJ; MOTT'S-DR PEPPER/SEVEN
UP, AVENEL, NJ, ETC - 483S 1/06 TO PRESENT
UNION
2010-6492 08/23/2010 ORA/SW-FO/KAN-DO/COMP/ MIRANDA NELSON DR PEPPER/SEVEN UP MANUFACTURING CO, ST LOUIS,
09/21/2010 UNITED FOOD & COMMERCIAL MO - 483S 1/06 TO PRESENT
UNION
2010-6493 08/23/2010 ORA/CE-FO/DET-DO/DCB/ MIRANDA NELSON THE AMERICAN BOTTLING CO, HOLLAND, MI - 483S 1/06 TO
PRESENT
UNION
2010-6494 08/23/2010 ORA/CE-FO/CIN-DO/CCB/ MIRANDA NELSON THE AMERICAN BOTTLING CO, LOUSIVLLE, KY - 483S 1/06
09/21/2010 UNITED FOOD & COMMERCIAL TO PRESENT
UNION
2010-6495 08/23/2010 ORA/SW-FO/KAN-DO/COMP/ MIRANDA NELSON THE AMERICAN BOTTLING CO, OTTUMWA, IA - 483S 1/06
TO PRESENT
UNION
2010-6496 08/23/2010 ORA/CE-FO/CHI-DO/CCB/ MIRANDA NELSON THE AMERICAN BOTTLING CO, NORTHLAKE, IL - 483S 1/06
TO PRESENT
UNION
2010-6497 08/23/2010 ORA/SE-FO/FLA-DO/FCB/ MIRANDA NELSON THE AMERICAN BOTTLING CO, JACKSONVILLE, MIAMI, FL -
09/21/2010 UNITED FOOD & COMMERCIAL 483S 1/06 TO PRESENT
UNION

Total Records: 908

Due Date
2010-6498 08/23/2010 CFSAN/OCD/EOS/ ELLEN GABLER BABY FOOD - TOTAL DIET STUDIES FROM MARKET
09/21/2010 CHICAGO TRIBUNE BASKETS 1/07 TO PRESENT
2010-6499 08/23/2010 CVM/OCD/ CMPLT 51072

09/21/2010 ORA/ RAKOWSKI, ARLENE
2010-6500 08/23/2010 ORA/CE-FO/CIN-DO/CCB/ ABBOTT NUTRITION, COLUMBUS, OH - EIR 5/1210 TO
5/27/10
2010-6501 08/23/2010 OM/OSS/OPILS/DFI/ 2008-778
2010-6502 08/23/2010 OM/OSS/OPILS/DFI/ 2010-325
2010-6503 08/23/2010 OM/OSS/OPILS/DFI/ 2010-283
2010-6504 08/23/2010 OM/OSS/OPILS/DFI/ 2010-251
2010-6505 08/23/2010 OM/OSS/OPILS/DFI/ 2010-36
2010-6506 08/23/2010 CDER/ORP/DIDP/ ISR 8597640
2010-6507 08/23/2010 OM/OSS/OPILS/DFI/ DAILY LOG 1/1/09 TO 12/31/09
2010-6508 08/23/2010 ORA/CE-FO/CIN-DO/CCB/ CMPLNT 9334420-04-09
09/21/2010 WILMOTH
2010-6509 08/23/2010 ORA/SE-FO/ATL-DO/ACB/ TRIAD FORENSICS LABORATORY LLC, WINSTON SALEM,
09/21/2010 FOI SERVICES INC NC - EIR, 483, WARNING LTR, CO RESP 2007 TO PRESENT
2010-6510 08/23/2010 ORA/NE-FO/NWE-DO/NWECB/ MILLENNIUM RESEARCH LABORATORIES INC, WOBURN,

MA - EIR, 483, WARNING LTR, CO RESP 2007 TO PRESENT
2010-6511 08/23/2010 CDER/ORP/DIDP/ SLATE PHARMS - TESTOPEL PELLETS WARNING LTRS,
CORR, CO RESP 3/24/10
2010-6512 08/23/2010 ORA/SW-FO/KAN-DO/COMP/ PATRICIA L. REGENYE MARCUS NEUBAUER, HEMAT ONCOL ASSOC MISSOURI ST
09/21/2010 Celgene Corporation LUKES PLZ OFFICE, KANSAS CITY, MO - 483, EIR, CO RESP
9/07 TO PRESENT
2010-6513 08/23/2010 ORA/ MARK G. MAZZIE EDUNEERING INC -TRANSITIONING FDA BASIC LAW
COURSE TO ON-LINE LEARNING
09/21/2010 CENTER FOR PROFESSIONAL
INNOVATION & EDUCATION INC

Total Records: 908

Due Date
2010-6514 08/23/2010 ORA/CE-FO/NJ-DO/NJCB/ JOHN COUGHLIN D & E PHARMACEUTICALS INC, BLOOMINGDALE, NJ - EIR
09/21/2010 WAKEFERN FOOD CORP MOST RECENT
2010-6515 08/23/2010 CDRH/OMO/DEMO/FOIB/ COLOR VEES IV SETS - K983411

09/21/2010 SHELTON, RENE
2010-6516 08/23/2010 CDER/ORP/DIDP/ LINUS GAARN JOHANSEN MOEHS CATALANA SA, RUBI, SPAIN - EIR, 483 2/10
09/21/2010 CDER/ORP/DIDP/ ORIFARM GENERICS A/S
2010-6517 08/24/2010 ORA/P-FO/LOS-DO/LACB/ GLP NON-CLINICAL LABORATORY/ BIOANALYTICAL
TESTING FACILITIES IN CALIFORNIA - 482S, 483S 7/08 TO
09/22/2010 ORA/P-FO/SAN-DO/SFCB/ SCHARBERG, DAVID L
12/08
2010-6518 08/24/2010 ORA/CE-FO/MIN-DO/MCB/ GLP NON-CLINICAL LABORATORY/ BIOANALYTICAL
09/22/2010 SCHARBERG, DAVID L TESTING FACILITIES IN WISCONSIN - 482S, 483S 1/08 TO
12/08
2010-6519 08/24/2010 ORA/NE-FO/NYK-DO/NYDCB/ GLP NON-CLINICAL LABORATORY/ BIOANALYTICAL
TESTING FACILITIES IN NEW YORK - 482S, 483S 1/09 TO
09/22/2010 SCHARBERG, DAVID L
6/09
2010-6520 08/24/2010 ORA/SE-FO/ATL-DO/ACB/ DANA THOMPSON REVOGENEX INC, WINDER, GA - EIRS, 483S, 482, ETC 1/10
09/22/2010 FULBRIGHT & JAWORSKI LLP TO PRESENT
2010-6521 08/24/2010 ORA/CE-FO/NJ-DO/NJCB/ DANA THOMPSON SETON PHARMACEUTICALS LLC, MANASQUAN, NJ - EIRS,
483S, 482, ETC 1/10 TO PRESENT
2010-6522 08/24/2010 ORA/SW-FO/KAN-DO/COMP/ DANA THOMPSON FLEMING & COMPANY, PHARM (FLEMING PHARMS),
FENTON, MO - EIRS, 483S, 482, ETC 1/10 TO PRESENT
2010-6523 08/24/2010 CVM/OCD/ ROBERT L MILLER DVM NOBIVAC LYME VACCINE, PREVICOX, METACAM &
09/22/2010 RESTON ANIMAL HOSPITAL DERAMAXX - AERS
2010-6524 08/24/2010 CDER/ORP/DIDP/ STEVEN R SCOTT XEOMIN (INCOBOTULINUMTOXIN A) - SBA, MOR, CMC,
09/22/2010 CDER/ORP/DIDP/ BIOMEASURE INC PHARMACOLOGY/TOXICOLOGY, ETC
2010-6525 08/24/2010 CDER/ORP/DIDP/ DUSTIN BLOCK DONEPEZIL HYDROCHLORIDE ANDA 077-344 - APRVL LTR
09/22/2010 CDER/ORP/DIDP/ IPD ANALYTICS LLC
2010-6526 08/24/2010 CDRH/OMO/DEMO/FOIB/ JOANNA NAPP K091109 - SUBMISSIONS, CORR, LBLG, ETC
09/22/2010 JACKSON WALKER LLP
2010-6527 08/24/2010 OM/OMP/DODM/ JOANNA NAPP DKT 1975N-0013 OR 1977N-0080 - COMPILATION
09/22/2010 JACKSON WALKER LLP (ANALYTICAL METHODOLOGY FOR POLYCHLORINATED
BIPHENYLS) 6/79
2010-6528 08/24/2010 CVM/OCD/ ADAM R BLOEDORN LYCOPENE IN ANIMAL FEED - CORR 2000-2005
2010-6529 08/24/2010 CDRH/OMO/DEMO/FOIB/ JOANNA NAPP K090239 - SUBMISSIONS, CORR, LBLG ETC

Total Records: 908

Due Date
2010-6530 08/24/2010 CDRH/OMO/DEMO/FOIB/ JOANNA NAPP K081920 - SUBMISSIONS, CORR, LBLG ETC
2010-6531 08/24/2010 CDRH/OMO/DEMO/FOIB/ WILLIAM E WININGHAM HOSPIRA WORLD WIDE INC - TRANSPAC IV
09/22/2010 OM/OSS/OPILS/DFI/ WILSON KEHOE & WINIGHAM NEONATAL/PEDIATRIC PRESSURE MONITORING KIT;
TRANSPAC DISPOSABLE TRANSDUCTER (BLOOD
OM/OSS/OPILS/DFI/ LLC
PRESSURE) W/MONITORING KIT K831506 & K831506A, ETC
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
2010-6532 08/24/2010 CDRH/OMO/DEMO/FOIB/ BIOMEDIX INC - Q STEPS BIOMETER G/C DUAL
09/22/2010 CHEN, SHYH-MIN MONITORING SYS K050182
2010-6533 08/24/2010 CVM/OCD/ BARBARA POULSEN NAUTRUP HETACIN K NADA 055-054 - SUMMARY OF EFFICACY DATA
09/22/2010 EAH CONSULTING
2010-6534 08/24/2010 OM/OSS/OPILS/DFI/ GLEN J MISHIMURA MORTON INTERNATIONAL INC, SOUTH HUTCHINSON, KS -
EIR, 483 MOST RECENT
09/22/2010 OM/OSS/OPILS/DFI/ Morton Salt
2010-6535 08/24/2010 ORA/CE-FO/DET-DO/DCB/ ANNE M ARMSTRONG SIXARP LLC-PRAXIS, GRAND RAPIDS, MI - EIR 5/18-28/10
09/22/2010 SIXARP LCC-PRAXIS
2010-6536 08/24/2010 OM/OSS/OPILS/DFI/ DARCI BOLGER 2010-5907
09/22/2010 OM/OSS/OPILS/DFI/ LEXIS NEXIS COURTLINK INC
2010-6537 08/24/2010 ORA/SW-FO/DEN-DO/COMP/ REGENERATIVE SCIENCES LLC, BROOMFIELD, CO - EIR,
483 8/6/10
09/22/2010 BARRETT, MATTHEW
2010-6538 08/24/2010 CFSAN/OCD/EOS/ CHARLES A STEWART III SOUTHERN VISIONS LLP - MOCHA, FRENCH VANILLA ICED
COFFEE BEVERAGE SALMONELLA CONTAMINATION
09/22/2010 ORA/SE-FO/NOL-DO/NOCB/ BRADLEY ARANT BOULT
CUMMINGS LLP RECALL RECS 6/29/09
2010-6539 08/24/2010 CDRH/OMO/DEMO/FOIB/ S CAROLYN RAMOS MAJID MOSHIRFAR MD - INSP, CORR, INTERVIEWS, ETC
09/22/2010 BUTT THORNTON & BAEHR PC 2004
2010-6540 08/24/2010 CDRH/OMO/DEMO/FOIB/ KIRK S DAVIS ESQ BAXTER - COLLEAGUE VOLUMERIC INFUSION PUMP
RECALL RECS
09/22/2010 ORA/CE-FO/CHI-DO/CCB/ AKERMAN SENTERFITT ATTYS
2010-6541 08/24/2010 CFSAN/OCD/EOS/ MIRIAM ROTKIN-ELLMAN MPH BP/DEEPWATER HORIZON GULF OF MEXICO OIL SPILL -
RECS
09/22/2010 ORA/ NATURAL RESOURCES
OM/OSS/OPILS/DFI/ DEFENSE COUNCIL/NRDC
OM/OSS/OPILS/DFI/
2010-6542 08/24/2010 CDRH/OMO/DEMO/FOIB/ SPOT ENDOSCOPIC MARKER - K993951
09/22/2010 GOBER, THERON

Total Records: 908

Due Date
2010-6543 08/24/2010 CDER/ORP/DIDP/ LIST OF DRUG APRVLS - PATENT TYPES, EXPIRATION
09/22/2010 CDER/ORP/DIDP/ GAUDRY, KATHERINE DATES, EXCLUSIVITY CODE, ETC 1/00 TO PRESENT
2010-6544 08/24/2010 CDER/ORP/DIDP/ DROPERIDOL - AERS

2010-6545 08/24/2010 OM/OSS/OPILS/DFI/ BOBBI DRUYOR-SANCHEX K083862 (CERTIFIED)
09/22/2010 OM/OSS/OPILS/DFI/ MEDAPPS INC
2010-6546 08/24/2010 OM/OSS/OPILS/DFI/ ANDREW TAJAE WRIGHT COUNTY EGG - EIRS, 483S 2000 TO PRESENT
09/22/2010 OM/OSS/OPILS/DFI/ TRIBUNE COMPANY
ORA/
2010-6548 08/24/2010 ORA/SE-FO/FLA-DO/FCB/ JOHN DORSCHNER UNIV OF MIAMI/UNIV OF MIAMI MILLER SCHOOOL OF
MEDICINE, SYLVESTER COMPREHENSIVE CANCER CTR -
09/22/2010 OM/OSS/OPILS/DFI/ MIAMI HERALD
483, CO RESP 2009, 2010
OM/OSS/OPILS/DFI/
2010-6549 08/25/2010 CDER/ORP/DIDP/ LOREN L SPEZIALE DR REDDY'S LABORATORIES LTD, DR REDDY'S
09/23/2010 CDER/ORP/DIDP/ GRAHAM CURTIN LABORATORIES INC, REDDY PHARMACEUTICALS INC -
IBUPROFEN ANDA 76-112 CORR, SUPPLEMENTS, STATUS
CHANGE, ETC
2010-6550 08/25/2010 CDER/ORP/DIDP/ JEFFREY BALTRUZAK ESQ PROCRIT, ARANESP - CORR, RECS 5/1/05
09/23/2010 CDER/ORP/DIDP/ MCDERMOTT WILL & EMERY
2010-6551 08/25/2010 CDER/ORP/DIDP/ JAMES R CARTER CIBA-GEIGY LTD, NOVARTIS PHARMACEUTICALS -
09/23/2010 CDER/ORP/DIDP/ CARTER LAW OFCS BRETHINE, BRETHAIRE (TERBUTALINE SULFATE)
WARNING LTRS, LBLG, NOTICE OF ADVERSE FINDINGS
LTRS (NAFLS), ETC
2010-6552 08/25/2010 CDER/ORP/DIDP/ NICHOLAS P LAURENT PFIZER INC - ZOLOFT WARNING LTR 8/96
09/23/2010 CDER/ORP/DIDP/ MCGINNIS LOCHRIDGE &
KILGORE LLP
2010-6553 08/25/2010 ORA/SE-FO/ATL-DO/ACB/ RANDY CARLTON CMPLNT 115081
09/23/2010 W JAMES CHANDLER PLLC
2010-6554 08/25/2010 ORA/SE-FO/FLA-DO/FCB/ FABIO AZEVEDO HECTOR WILTZ MD, INTERNATIONAL DERMATOLOGY
RESEARCH INC, MIAMI, FL - 483 2/7/05
09/23/2010 INTERNATIONAL
DERMATOLOGY RESEARCH INC
2010-6555 08/25/2010 ORA/ORM/ TONY CHEN LIST OF 483S ISSUED 6/10 TO PRESENT

Total Records: 908

Due Date
09/23/2010 FDAZILLA
2010-6556 08/25/2010 ORA/SE-FO/NOL-DO/NOCB/ CMPLNT 115412
09/23/2010 Doe J
2010-6557 08/25/2010 ORA/NE-FO/NYK-DO/NYDCB/ BRUCE H STERN RONALD L VAN HEERTUM MD, RAY KREITCHMAN PET
09/23/2010 STARK & STARK CENTER, COLUMBIA PRESBYTERIAN MEDICAL CENTER,
NEW YORK, NY - INVESTIGATION 6/08, WARNING LTRS,
ETC
2010-6558 08/25/2010 ORA/SW-FO/DAL- CMPLNT 115829
DO/COMPLIANCE/
09/23/2010 SCHEEL, CHRISTOPHER J
2010-6559 08/25/2010 ORA/CE-FO/DET-DO/DCB/ MEAD-JOHNSON NUTRITIONALS, EVANSVILLE,L IN - EIR,
483 MOST RECENT
09/23/2010 BREININGER, JASON
2010-6560 08/25/2010 ORA/SE-FO/ATL-DO/ACB/ THOMAS E GRAHAM KELLOGG CO, ROME, COLUMBUS, AUGUSTA, GA, ETC -
09/23/2010 LANCE INC EIRS 1/10 TO PRESENT
2010-6561 08/25/2010 ORA/NE-FO/NWE-DO/NWECB/ TIMOTHY MAYHEW CISPLATIN INJ LOTS 397-138-001 E1, 397-138-001 E2 -
09/23/2010 AMRI BURLINGTON RPT ANALYSIS
2010-6562 08/25/2010 OM/OSS/OPILS/DFI/ DARCI BOLGER 2010-5712

09/23/2010 OM/OSS/OPILS/DFI/ LEXISNEXIS COURTLINK INC
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
2010-6563 08/25/2010 OM/OSS/OPILS/DFI/ COASTAL INTERNATIONAL SECURITY - SECURITY GUARD
09/23/2010 OM/OSS/OPILS/DFI/ GLADDEN, KIM DESHONNE FPS CONTRACT
2010-6566 08/25/2010 CDER/ORP/DIDP/ MARILYNN WHITNEY YASMIN TABS - THROMBOEMBOLIC EVENTS RVWS 4/30/01
2010-6567 08/25/2010 CDER/ORP/DIDP/ MARILYNN WHITNEY YASMIN TABS - THROMBOEMBOLIC EVENTS RVW 3/6/02
2010-6568 08/25/2010 ORA/SW-FO/KAN-DO/COMP/ SONYA HEITSHUSEN WRIGHT COUNTY EGG, HILLANDALE FARMS - EIRS 2000
TO PRESENT
09/23/2010 ORA/ WHO-TV
2010-6569 08/25/2010 CDER/ORP/DIDP/ NDC #61577 - MFR
09/23/2010 CDER/ORP/DIDP/ GUISE, ELISE

Total Records: 908

Due Date
2010-6571 08/25/2010 CDRH/OMO/DEMO/FOIB/ BRIAN RECUPERO DEVELOPMENT OF IN VITRO PEEL ADHESION TESTING
09/23/2010 CDER/ORP/DIDP/ AVERY DENNISON FOR TRANSDERMAN DRUG DELIVERY SYSTEM
CDER/ORP/DIDP/
2010-6572 08/26/2010 OM/OSS/OPILS/DFI/ TIM SANDLER 9 FOI REQUESTS; PROVENGE, DENDREON - FOI
REQUESTS 1/05 TO PRESENT
09/24/2010 OM/OSS/OPILS/DFI/ NBC NEWS
2010-6573 08/26/2010 CVM/OCD/ PETAG - NEWBORN ANIMAL FORMULAS INVESTIGATIONS,
09/24/2010 ORA/SW-FO/KAN-DO/COMP/ CUMMINS, MARY CIMPLNTS, CORR, LAB RESULTS, ETC
2010-6574 08/26/2010 CBER/OCTMA/DDOM/ALFB/ WIN CHEUNG ROCHE MOLECULAR SYSTEMS INC - COBAS TAQSCREEN
09/24/2010 SAMSUNG TECHWIN AMERICA MPX TEST STN BL 125255/0 SBA
2010-6575 08/26/2010 CDRH/OMO/DEMO/FOIB/ ELAINE RIZZO STIEFEL LABORATORIES INC - MIMYX K041342; MEDIX
PHARMACEUTICALS AMERICAS INC - BIAFINE WOUND
09/24/2010 OM/OSS/OPILS/DFI/ B & H CONSULTING SERVICES,
INC. DRESSING EMULSION K964240; SINCLAIR
OM/OSS/OPILS/DFI/ PHARMACEUTICALS LTD - SINCLAIR WOUND AND SKIN
EMULSION K024367
2010-6576 08/26/2010 ORA/ORO/DIOP/ HAMANAKO - UNAGI (BROILED EEL) IMPORT STATUS
09/24/2010 NAKAMURA, DEAN
2010-6577 08/26/2010 CDER/ORP/DIDP/ MISUSE AND PROPER USE OF ANTIBIOTICS - RECS
09/24/2010 CDER/ORP/DIDP/ PAVELA #1513374, JASON K
2010-6578 08/26/2010 OC/OM/OSS/OAGS/ CHEYENNE JOHNSON ICF INFORMATION TECHNOLOGY - CONTRACT
#HHSF223201010441G
09/24/2010 OM/OSS/OPILS/DFI/ FED SOURCES
OM/OSS/OPILS/DFI/
2010-6579 08/26/2010 CDRH/OMO/DEMO/FOIB/ PATRICIA L GIFFORD ARJO INC - MAXI MOVE SLING MDRS, WARNING LTRS,
09/24/2010 ORA/CE-FO/CHI-DO/CCB/ LEVIN & PERCONTI CORR, ETC
2010-6580 08/26/2010 ORA/ORM/ TONY CHEN DRUG & DVC 483S 1/08 TO PRESENT
09/24/2010 FDAZILLA
2010-6581 08/26/2010 CDER/ORP/DIDP/ XIMENA R SKOVRON ESQ AMAG PHARMACEUTICALS INC - FERAHEME
09/24/2010 CDER/ORP/DIDP/ ABRAHAM FRUCHTER & (FERUMOXYTOL INJ) AERS, CORR
TWERSKY LLP
2010-6582 08/26/2010 CDER/ORP/DIDP/ VAXA - ATTEND AERS

Total Records: 908

Due Date
09/24/2010 CDER/ORP/DIDP/ THUEN, LYNNE
CFSAN/OCD/EOS/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
CFSAN/OCD/EOS/
2010-6583 08/26/2010 CDER/ORP/DIDP/ HEMOGLOBINOPATHY RESEARCH PROGRAM, UNIV
HELATH NETWORK, TORONTO GENERAL HOSPITAL,
09/24/2010 CDER/ORP/DIDP/ RUBIN, KEN
TORONTO, ONTARIO, CANADA - EIR 7/09
2010-6584 08/26/2010 ORA/CE-FO/DET-DO/DCB/ PAUL W TRIPP JASPER COUNTY HOSPITAL, IN - EIRS, 483S, WARNING
09/24/2010 LINCARE INC LTRS 1/03 TO PRESENT
2010-6585 08/26/2010 ORA/SW-FO/DAL- WILLIAM M SLAUGHTER II SPL 630722, 630723, 630724 - ANALYTICAL RESULTS
DO/COMPLIANCE/
09/24/2010 TEJAS INDUSTRIES
2010-6586 08/26/2010 CDER/ORP/DIDP/ ANN B GIBSON OXYCONTIN TABS (OXYCODONE HCL CONTROLLED
RELEAASE) NDA 22-272 - RECS
09/24/2010 CDER/ORP/DIDP/ ELI LILLY & CO
2010-6587 08/26/2010 ORA/SW-FO/DAL- LEN CANNON TEXAS EGG FARMS - EIR 2009-2010
09/24/2010 DO/COMPLIANCE/ KHOU-TV 11
2010-6588 08/26/2010 CDER/ORP/DIDP/ DEMOULAS SUPER MARKETS INC, TEWKSBURY, MA -
09/24/2010 CDER/ORP/DIDP/ MELLEN, JAY PATRICK CMPLNTS, REGISTRATION; DRUGS THAT CASUE
ARTHRITIS - RECS
2010-6589 08/26/2010 ORA/NE-FO/NWE-DO/NWECB/ VANESSA L SMITH SCOTT REUBEN MD - EIRS, 483S
09/24/2010 BULKLEY RICHARDSON AND
GELINAS LLP
2010-6590 08/26/2010 ORA/CE-FO/MIN-DO/MCB/ BETSY Q CLIFF DR RICHARD COHEN, MEDLEAN, DUXBURY, MA; OCUZYME,
ASHEVILLE, NC; PALLADIUM HEALTH, BEND, OR, ETC -
09/24/2010 ORA/NE-FO/NWE-DO/NWECB/ BULLETIN
OPTIMALE INSPS, WARNING LTRS, ETC
ORA/SW-FO/DAL-
DO/COMPLIANCE/
2010-6591 08/26/2010 CDRH/OMO/DEMO/FOIB/ DR ROY NELSON K080532
09/24/2010 CARBON & POLYMER
RESEARCH INC
2010-6592 08/26/2010 ORA/SE-FO/ATL-DO/ACB/ TRUEMAN TUCK LIQUID PACKAGING RESOURCES INC, ATLANTA, GA - EIR,
09/24/2010 TUCK'S PROFESSIONAL 483 MOST RECENT
SERVICES
2010-6593 08/26/2010 CDRH/OMO/DEMO/FOIB/ STEVEN HAKEN MANUKA MEDICAL LTD - MANUKAPLI WOUND DRESSING

Total Records: 908

Due Date
09/24/2010 MANUKA MEDICAL K092689
2010-6594 08/26/2010 CDRH/OMO/DEMO/FOIB/ DAVID J BURTON SGARLATO PAIN CONTROL INFUSION PUMP - K990101
09/24/2010 BURTON & SIMKIN
2010-6595 08/26/2010 CDRH/OMO/DEMO/FOIB/ DAVID J BURTON BURRON AMBULATORY DRUG DELIVERY SYS - K896422
09/24/2010 BURTON & SIMKIN
2010-6596 08/26/2010 CDER/ORP/DIDP/ EISAI - ARICEPT NDA 22-568 APRVL RECS
2010-6597 08/26/2010 CDER/ORP/DIDP/ ABBOTT - SIMOCOR NDA 22-078/S006 APRVL RECS
2010-6598 08/26/2010 CDER/ORP/DIDP/ ROXANE LABORATORIES INC - MYCOPHENOLATE
09/24/2010 CDER/ORP/DIDP/ FOI SERVICES INC MOFETIL ANDA 65-410 RECS
2010-6599 08/27/2010 ORA/CE-FO/BLT-DO/CB/ MCREADY HOSPITAL, CRISFIELD, MD - MQSA

MAMMOGRAPHY INSP 10/08
09/27/2010 LANDON, CATHY L
2010-6600 08/27/2010 CDER/ORP/DIDP/ DANIEL J HARRINGAN CHANTIX (VARENICLINE) - DIABETES RISK RECS
09/27/2010 CDER/ORP/DIDP/ BAYLIFF HARRIGAN CORD LLP
2010-6601 08/27/2010 CDER/ORP/DIDP/ ABBOTT LABS - SYNTHROID PILL WEIGHT
09/27/2010 CDER/ORP/DIDP/ CALLAS, STEVE
2010-6602 08/27/2010 CDER/ORP/DIDP/ SATISH V POONDI IMPAX LABORATORIES INC, MYLAN PHARMACEUTICALS
INC, UPSHIRE-SMITH LABORATORIES INC, ETC -
09/27/2010 CDER/ORP/DIDP/ WILENTZ GOLDMAN & SPITZER
PA MIDODRINE HCL CLNCL TRIALS 1/04 TO 12/08; 1/09 TO
PRESENT
2010-6603 08/27/2010 CDER/ORP/DIDP/ SANOFI-AVENTIS PHARMS - MULTAQ (DRONEDARONE)
AERS
09/27/2010 CDER/ORP/DIDP/ WATERS, LARISA
2010-6604 08/27/2010 OM/OSS/OPILS/DFI/ TIM SANDLER 2010-5568, 2009-10001
09/27/2010 OM/OSS/OPILS/DFI/ NBC NEWS
2010-6605 08/27/2010 CDER/ORP/DIDP/ DAVID W CARROLL BAYER CORP - MIRENA IMPORT RECS
09/27/2010 CDER/ORP/DIDP/ ROBERTS CARROLL FELDSTEIN
OM/OSS/OPILS/DFI/ & PIERCE INC
OM/OSS/OPILS/DFI/
2010-6606 08/27/2010 CDER/ORP/DIDP/ MARK GREENBLATT AERS DATABASE 2005 TO PRESENT
09/27/2010 CDER/ORP/DIDP/ KHOU-TV 11
2010-6607 08/27/2010 ORA/SW-FO/KAN-DO/COMP/ ALEXANDRIA DILIS MDS PHARMA SERVICES, LINCOLN, NE - EIR 1/28-29/08
09/27/2010 CELERION
2010-6608 08/27/2010 ORA/SW-FO/KAN-DO/COMP/ ALEXANDRIA DILIS MDS PHARMA SERVICES, LINCOLN, NE - EIR 12/8-11/08

Total Records: 908

Due Date
09/27/2010 CELERION
2010-6609 08/27/2010 ORA/SW-FO/KAN-DO/COMP/ ALEXANDRIA DILIS MDS PHARMA SERVICES, LINCOLN, NE - EIR 7/31/06-8/4/06
09/27/2010 CELERION
2010-6610 08/27/2010 CDER/ORP/DIDP/ ALEXANDRA DILIS MDS PHARMA SERVICES, QUEBEC, CANADA - EIR 11/28/06-
09/27/2010 CDER/ORP/DIDP/ CELERION 12/1/06
2010-6611 08/27/2010 CDER/ORP/DIDP/ DONEPEZIL - AER

2010-6612 08/27/2010 ORA/SE-FO/FLA-DO/FCB/ POWER MEDICA METRAGEN PHARMS, DEERFIELD BEACH,
09/27/2010 DONALD A BOGGS PE FL - CORR, CLIENT LIST 2/15/05
2010-6613 08/27/2010 CDRH/OMO/DEMO/FOIB/ AMY E. BOYD BIOMET INC - ASCENT KNEE SYS K982869; BIOMET INC -
09/27/2010 FOLEY HOAG LLP AGC& MAXIM W/NTS K922285; BIOMET INC - ASCENT KNEE
SYS K884796 CERTIFIED COPIES
2010-6614 08/27/2010 CDRH/OMO/DEMO/FOIB/ BETSY Q. CLIFF DR. RICHARD COHEN - WARNING LTR
09/27/2010 BULLETIN
2010-6615 08/30/2010 CFSAN/OCD/EOS/ KATERYNA L RAKOWSKY GENETICALLY ENGINEERED SALMON - RECS
09/28/2010 CVM/OCD/ CENTER FOR FOOD SAFETY
OC/COS/OES/
OC/COS/OES/
OC/OCC/
2010-6616 08/30/2010 CDRH/OMO/DEMO/FOIB/ MEDICAL CONCEPTS DEVELOPMENT INC - ACTI-GARD
K000442
09/28/2010 CHANG, BRENDA
2010-6617 08/30/2010 OM/OSS/OPILS/DFI/ STEPHEN M KOHN KELLY GROUP - CONTRACT
09/28/2010 OM/OSS/OPILS/DFI/ KOHN KOHN & COLAPINTO LLP
CDRH/OMO/DEMO/FOIB/
2010-6618 08/30/2010 ORA/SE-FO/FLA-DO/FCB/ SUSAN SWAMBACK FXM RESEARCH, MIAMI, FL - EIR 5/13/09-9/3/09
09/28/2010 SYMBIO LLC
2010-6619 08/30/2010 CDRH/OMO/DEMO/FOIB/ COOPERVISION MFG - PROSTHETIC SOFT CONTACT LENS
K042435
09/28/2010 LOITERMAN, MIKE
2010-6620 08/30/2010 CDRH/OMO/DEMO/FOIB/ SYBIL SHAINWALD BIOENTERICS CORP - LAP-BAND SYS POST MARKET
09/28/2010 SYBIL SHAINWALD LAW OFCS STUDY 5/25/01, 5/31/01, PMA
2010-6621 08/30/2010 CDER/ORP/DIDP/ XANAX - RECS

09/28/2010 CDER/ORP/DIDP/ WOOLSEY, ELIZABETH ERIN
2010-6622 08/30/2010 CDER/ORP/DIDP/ WELLBUTRIN (BUPROPION) - RECS
09/28/2010 CDER/ORP/DIDP/ WOOLSEY, ELIZABETH ERIN

Total Records: 908

Due Date
2010-6623 08/30/2010 ORA/SE-FO/ATL-DO/ACB/ KRISTI O SMEDLEY PHD ADVANCED LABS, SMITHFIELD, NC - EIR 2/4-7/08
09/28/2010 Center for Regulatory Services, Inc.
2010-6624 08/30/2010 ORA/SE-FO/NOL-DO/NOCB/ KRISTI O SMEDLEY PHD EIRS, 483S CONDUCTED BY MARIE MORIN 2007-2010
09/28/2010 CDER/ORP/DIDP/ Center for Regulatory Services, Inc.
CDER/ORP/DIDP/
2010-6625 08/30/2010 CDRH/OMO/DEMO/FOIB/ DEPUY ORTHOPAEDICS - DEPUY RESTORE
ORTHOBIOLOGIC SOFT TISSUE IMPLANT K031969
2010-6626 08/30/2010 CDRH/OMO/DEMO/FOIB/ ONCOBIONIC INC - ONCOBIONIC SYS K080376
2010-6627 08/30/2010 CDER/ORP/DIDP/ ADR HIGHLIGHT 1982-1983
2010-6628 08/30/2010 CDRH/OMO/DEMO/FOIB/ DEPUY ORTHOPAEDICS - DELTA XTEND REVERSE
SHOULDER SYS K062250
2010-6629 08/30/2010 CDRH/OMO/DEMO/FOIB/ TORNIER - AEQUALIS REVERSED SHOULDER PROSTHESIS
K030941
2010-6630 08/30/2010 CDRH/OMO/DEMO/FOIB/ HOWMEDICA OSTEONICS - RESTORATION ADM SYS
2010-6631 08/30/2010 CDRH/OMO/DEMO/FOIB/ MEDACTA INTERNATIONAL - VERSAFIT CUP DOUBLE

MOBILITY SYS K083116
2010-6632 08/30/2010 CDRH/OMO/DEMO/FOIB/ PLUS ORTHOPEDICS AG - POLARCUP DUAL MOBILITY SYS
K070278
2010-6633 08/30/2010 CDRH/OMO/DEMO/FOIB/ 510KS 1/1-31/10
2010-6634 08/30/2010 OM/OSS/OPILS/DFI/ 2010-271
2010-6635 08/30/2010 OM/OSS/OPILS/DFI/ 2010-344
2010-6636 08/30/2010 OM/OSS/OPILS/DFI/ 2010-158
2010-6637 08/30/2010 OM/OSS/OPILS/DFI/ 2009-10243
2010-6638 08/30/2010 OM/OSS/OPILS/DFI/ 2009-8261

Total Records: 908

Due Date
2010-6639 08/30/2010 OM/OSS/OPILS/DFI/ 2009-10042
2010-6640 08/30/2010 OM/OSS/OPILS/DFI/ 2010-297
2010-6641 08/30/2010 CDER/ORP/DIDP/ COMBINED HORMONAL CONTRACEPTIVE (CHC) DRUGS:
THROMBOEMBOLIC DISEASE AND DEATH OUTCOMES -
PROTOCOL & ANALYSIS
2010-6642 08/30/2010 CDRH/OMO/DEMO/FOIB/ 510KS 2/1-31/10
2010-6643 08/30/2010 ORA/P-FO/LOS-DO/LACB/ ST JUDE MEDICAL, CYLMAR, CA - EIR, 483, CO RESP, ETC
09/28/2010 FOI SERVICES INC 6/1/10-8/24/10
2010-6644 08/30/2010 CBER/OCTMA/DDOM/ALFB/ CHIRON - PROCLEIX OPTIVA RAS BK050004

2010-6645 08/30/2010 OC/OM/OMP/DDM/ ANGELIA SLAYTON ODAC TRANS 12/16/96
2010-6646 08/31/2010 OC/OM/OMP/DDM/ ADAM BLOEDORN DKT 1995S-0316
2010-6648 08/31/2010 OM/OSS/OPILS/DFI/ KENNETH REID FOI DAILY LOG - 8/16-20/10
SOURCE
2010-6649 08/31/2010 OM/OSS/OPILS/DFI/ DEBI COHEN FOI DAILY LOG - 8/16-20/10
BUSINESS
2010-6650 08/31/2010 OM/OSS/OPILS/DFI/ CECELIA FRENCH FOI DAILY LOG - 8/16-20/10
2010-6652 08/31/2010 OM/OSS/OPILS/DFI/ GLADYS TONKIN FOI DAILY LOG - 8/16-20/10
2010-6653 08/31/2010 OM/OSS/OPILS/DFI/ CECELIA FRENCH CLSOED FOI REQUESTS 8/16-20/10

Total Records: 908

Due Date
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
2010-6655 08/31/2010 OM/OSS/OPILS/DFI/ FOI DAILY LOG - 8/16-20/10
2010-6657 08/31/2010 CFSAN/OCD/EOS/ JED KURZBAN ESQ ACTIVE NUTRITION CORP - RAGE RV5 CAERS, WARNINGS,
09/29/2010 ORA/SE-FO/ATL-DO/ACB/ KURZBAN KURZBAN WEINDER LBLG, ETC
TETZELI AND PRATT PA
2010-6658 08/31/2010 OM/OSS/OPILS/DFI/ FOI DAILY LOG - 8/2-6/10; 8/9-13/10
2010-6659 08/31/2010 CDRH/OMO/DEMO/FOIB/ INTUITIVE SURGICAL INC, SUNNYVALE, CA - RECS
09/29/2010 ORA/P-FO/SAN-DO/SFCB/ O'BRIEN, DANIEL
2010-6660 08/31/2010 CDER/ORP/DIDP/ KUMARA SEKAR PHD GLAXO SMITHKLINE - ALKERAN (MELPHALAN HCL) INJ NDA
20-207 SBA
09/29/2010 CDER/ORP/DIDP/ DR REDDY'S LABORATORIES
INC
2010-6661 08/31/2010 CDER/ORP/DIDP/ SINGULAIR - AERS
09/29/2010 CDER/ORP/DIDP/ NEWPORT, ERIN E
2010-6662 08/31/2010 CDER/ORP/DIDP/ TRACEY BRIDGMAN ASTRAZENECA - BUPIVACAINE, LIDOCAINE PROD NAME
INDEX
09/29/2010 CDER/ORP/DIDP/ ICEMILLER, LLP
2010-6663 08/31/2010 OM/OSS/OPILS/DFI/ 2010-3376, 2010-3377, 2010-2613
09/29/2010 OM/OSS/OPILS/DFI/ SIEGEL, ABBY
2010-6664 08/31/2010 ORA/SE-FO/FLA-DO/FCB/ HONEY BPH-3044707-7, BPH-3044708-5 - ANALYTICAL
09/29/2010 KALOGEROPOULOS, RPT
CLAUDETTE
2010-6665 08/31/2010 CDRH/OMO/DEMO/FOIB/ THOMAS MARTIN JR SUN ERGOLINE - SUNDASH RADIUS 252 UPRIGHT
09/29/2010 ORA/ MARTIN, ELLIOTT & SNELL PC TANNING BED CMPLNTS, 483S, LAWSUITS ETC
2010-6666 08/31/2010 ORA/SW-FO/KAN-DO/COMP/ PAM CANO SPARHAWK LABORATORIES INC, VETERINARY

LABORATORIES INC, LENEXA, KS - EIRS, 483 2009-2010
09/29/2010 PEERLESS PATENTS LTD
2010-6667 08/31/2010 OM/OSS/OPILS/DFI/ DARREN L SCHULTZ MCNEIL CONSUMER HEALTHCARE - 483S 1/1/95-8/11/10
2010-6668 08/31/2010 OM/OSS/OPILS/DFI/ DARREN L SCHULTZ MCNEIL CONSUMER HEALTHCARE - EIRS 1/1/95-8/11/10

Total Records: 908

Due Date
2010-6669 08/31/2010 OM/OSS/OPILS/DFI/ DARREN L SCHULTZ MCNEIL CONSUMER HEALTHCARE (AKA MCNEIL
09/29/2010 OM/OSS/OPILS/DFI/ BRIAN D WITZER INC CONSUMER & SPECIALTY PHARMACEUTICALS) - WARNING
LTRS 1/1/95 TO PRESENT
2010-6670 08/31/2010 ORA/CE-FO/CIN-DO/CCB/ CTI SCIENCE - WARNING LTR RESP 7/10
09/29/2010 LOFTUS, JEAN M
2010-6671 08/31/2010 ORA/SW-FO/DEN-DO/COMP/ MEDIVANCE INC, BOULDER, CO - AUDIT MOST RECENT
09/29/2010 KLOS, BRAD
2010-6672 08/31/2010 ORA/SE-FO/FLA-DO/FCB/ WHOLE FOOD, PALM BEACH GARDENS, FL;
09/29/2010 TODD S STEWART LAW OFCS INCREDIBLEFISH, MIAMI, FL; FLORIDA'S FINEST SEAFOOD
CO, LAUDERHILL, FL - EIRS
2010-6673 08/31/2010 CBER/OCTMA/DDOM/ALFB/ AMANDA C SANCHEZ NORTHWESTERN UNIV, DIVISION OF IMMUNOTHERAPY -
PHASE 11 TRIAL OF HIGH DOSE IMMUNOTHERAPY AND
09/29/2010 ORA/CE-FO/CHI-DO/CCB/ RODEY DICKASON SLOAN ET AL
STEM CELL TRANSPLANTATION IN PATIENTS WITH
SYSTEMIC LUPUS ERYTHEMATOSUS
2010-6675 08/31/2010 CDRH/OMO/DEMO/FOIB/ DAVID B ALLEN ESQ BURRON AMBULATORY DRUG DELIVERY SYS - K896422
09/29/2010 COHEN & MALAD LLP
2010-6676 08/31/2010 ORA/ORO/DIOP/ LINDA ROTHFIELD EXPEDITORS INTERNATIONAL - ERROR RATES, RESULTS
OF FLIER EVALUATIONS
09/29/2010 Pier 1 Imports
2010-6677 08/31/2010 ORA/NE-FO/NWE-DO/NWECB/ VIVIAN A CABALLERO FRESENIUS MEDICAL CARE NORTH AMERICA, WALTHAM,
09/29/2010 BRAINTREE LABORATORIES INC MA - EIRS, 483S 1/09 TO PRESENT
2010-6678 08/31/2010 CFSAN/OCD/EOS/ MEAD JOHNSON - ENFAMIL PREMIUM LIPIL INFANT

09/29/2010 SIEGEL, ABBY FORMULA NOTIFICATION, MINS, CORR, ETC
2010-6679 08/31/2010 CDER/ORP/DIDP/ REGLAN (METOCLOPRAMIDE), COMPAZINE

(PROCHLORPERAZINE), TRILAFON (PERPHENAZINE), ETC -
09/29/2010 CDER/ORP/DIDP/ WARNER JR #502352, CHARLES
CLAY AERS
2010-6680 08/31/2010 CDER/ORP/DIDP/ MATTHEW MONTGOMERY MERCK - MK-0524A (ER NIACIN/LAROPIPRANT) NOT
APPROVABLE ACTION LTR 4/29/08
09/29/2010 CDER/ORP/DIDP/ SCOTT & SCOTT LLP
2010-6681 08/31/2010 CFSAN/OCD/EOS/ PINE NUT SYNDROME - RECS
09/29/2010 OWENS, STACY
2010-6682 08/31/2010 ORA/NE-FO/NYK-DO/NYDCB/ WALTER E CHALKLEY JOEL M KREMER, ALBANY, NY - EIR, 483 5/18/05-6/23/05
2010-6683 08/31/2010 ORA/SW-FO/DEN-DO/COMP/ WALTER E CHALKLEY HERMAN A JENKINS MD, AURORA, CO - EIR, 483, CO RESP
4/21/10-5/28/10

Total Records: 908

Due Date
2010-6684 08/31/2010 ORA/SW-FO/DEN-DO/COMP/ WALTER E CHALKLEY AMGEN, LONGMONT, CO - EIR, 483, CO RESP 7/12-16/04
2010-6685 08/31/2010 OM/OSS/OPILS/DFI/ JUDITH SCOLNICK 2010-4533 - DELETED RECS
09/29/2010 OM/OSS/OPILS/DFI/ SCOTT + SCOTT, LLC
2010-6686 08/31/2010 ORA/NE-FO/NYK-DO/NYDCB/ WALTER E CHALKLEY ALBANY MOLECULAR RESEARCH, ALBANY, NY - EIR, 483,
CO RESP 3/2/10-4/1/10
2010-6687 08/31/2010 ORA/P-FO/SEA-DO/SCB/ WALTER E CHALKLEY SNBL USA LTD, EVERETT, WA - EIR, 483, CO RESP 7/21/08-
8/1/08, 11/16-20/09
2010-6688 08/31/2010 CDRH/OMO/DEMO/FOIB/ KEITH MEYER MID-CONTINENTAL DENTAL SUPPLY CO LTD, WINNIPEG,
09/29/2010 MID-CONTINENTAL DENTAL MONITOBA, CANADA - RECS
SUPPLY CO LTD

Food and Drug Administration - FOIA Logs - August 2010

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Food and Drug Administration - FOIA Logs - August 2010

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Disclosure FOI Request Log Date range from 08/01/2010 to 08/31/2010 Report

Total Records: 908

Control # Recd Date / Action Office Signature/ Requester Subject

2010-5788 08/02/2010 OM/OSS/OPILS/DFI/ 2007-1200

2010-5792 08/02/2010 CDRH/OMO/DEMO/FOIB/ DAVITA CLINICAL RESEARCH - DBB-05 HEMODIALYSIS

Page 1 of 65 Thursday September 9 2010 4:28 PM

Control # Recd Date / Action Office Signature/ Requester Subject

2010-5799 08/02/2010 CDRH/OMO/DEMO/FOIB/ GAMBRO RENAL PRODUCTS - PRISMASATE DIALYSIS

Page 2 of 65 Thursday September 9 2010 4:28 PM

Control # Recd Date / Action Office Signature/ Requester Subject

2010-5822 08/03/2010 CDRH/OMO/DEMO/FOIB/ VIRGINIA SMITH K061041

Page 3 of 65 Thursday September 9 2010 4:28 PM

Control # Recd Date / Action Office Signature/ Requester Subject

2010-5826 08/03/2010 CDRH/OMO/DEMO/FOIB/ VIRGINIA SMITH K001323

Page 4 of 65 Thursday September 9 2010 4:28 PM

Control # Recd Date / Action Office Signature/ Requester Subject

2010-5846 08/03/2010 ORA/SE-FO/ATL-DO/ACB/ ENTRY #FF1203575-5 - LAB RPT

Page 5 of 65 Thursday September 9 2010 4:28 PM

Control # Recd Date / Action Office Signature/ Requester Subject

2010-5860 08/03/2010 CDER/ORP/DIDP/ ABBOTT LABORATORIES DE MEXICO S A DE CV -

2010-5866 08/03/2010 CDRH/OMO/DEMO/FOIB/ JOSEPH E KOLAR DEPUY ORTHOPAEDICS - MDR 181890-2009-02141

Page 6 of 65 Thursday September 9 2010 4:28 PM

Control # Recd Date / Action Office Signature/ Requester Subject

2010-5868 08/03/2010 CDER/ORP/DIDP/ SCHERING-PLOUGH S A DE C V - DESENFRIO D MFR

Page 7 of 65 Thursday September 9 2010 4:28 PM

Control # Recd Date / Action Office Signature/ Requester Subject

Page 8 of 65 Thursday September 9 2010 4:28 PM

Control # Recd Date / Action Office Signature/ Requester Subject

Page 9 of 65 Thursday September 9 2010 4:28 PM

Control # Recd Date / Action Office Signature/ Requester Subject

Page 10 of 65 Thursday September 9 2010 4:28 PM

Control # Recd Date / Action Office Signature/ Requester Subject

Page 11 of 65 Thursday September 9 2010 4:28 PM

Control # Recd Date / Action Office Signature/ Requester Subject

2010-5938 08/05/2010 CDER/ORP/DIDP/ MERZ PHARMS - NAFTIN CREAM NDA 19-5992/S001,002

Page 12 of 65 Thursday September 9 2010 4:28 PM

Control # Recd Date / Action Office Signature/ Requester Subject

2010-5943 08/05/2010 CBER/OCTMA/DDOM/ALFB/ HEMOLYTIC TRANSFUSION - RPT

Page 13 of 65 Thursday September 9 2010 4:28 PM

Control # Recd Date / Action Office Signature/ Requester Subject

2010-5966 08/05/2010 CDER/ORP/DIDP/ ELLIOT ISRAEL MD TIOTROPIUM - IND 101,608 RECS

2010-5968 08/05/2010 CDER/ORP/DIDP/ ADEZA BIOMEDICAL - GESTIVA 17 ALPHA-

Page 14 of 65 Thursday September 9 2010 4:28 PM

Control # Recd Date / Action Office Signature/ Requester Subject

2010-5985 08/05/2010 CDRH/OMO/DEMO/FOIB/ DIONNE SANDERS BIOMET MANUFACTURING CORP - VITAMIN E

Page 15 of 65 Thursday September 9 2010 4:28 PM

Control # Recd Date / Action Office Signature/ Requester Subject

Page 16 of 65 Thursday September 9 2010 4:28 PM

Control # Recd Date / Action Office Signature/ Requester Subject

Page 17 of 65 Thursday September 9 2010 4:28 PM

Control # Recd Date / Action Office Signature/ Requester Subject

Page 18 of 65 Thursday September 9 2010 4:28 PM

Control # Recd Date / Action Office Signature/ Requester Subject

Page 19 of 65 Thursday September 9 2010 4:28 PM

Control # Recd Date / Action Office Signature/ Requester Subject

2010-6043 08/09/2010 OM/OSS/OPILS/DFI/ FOI DAILY LOG 7/26-30/10

2010-6051 08/09/2010 CDRH/OMO/DEMO/FOIB/ ELLMAN INTL - SURGI-MAX K061174

Page 20 of 65 Thursday September 9 2010 4:28 PM

Control # Recd Date / Action Office Signature/ Requester Subject

Page 21 of 65 Thursday September 9 2010 4:28 PM

Control # Recd Date / Action Office Signature/ Requester Subject

Page 22 of 65 Thursday September 9 2010 4:28 PM

Control # Recd Date / Action Office Signature/ Requester Subject

Page 23 of 65 Thursday September 9 2010 4:28 PM