Food and Drug Administration - FOIA Logs - August 2010

8/8/2019 Food and Drug Administration - FOIA Logs - August 2010

1/65

Thursday September 9 2010 4:28 PM

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

Total Records: 908

Page 1 of 65

Control # Recd Date / Due Date

Action Office Signature/ Requester Subject

FOI DAILY LOG 7/19-23/10



FOI DAILY LOG 7/19/23/10



BL HEALTHCARE - TCX-I-DV REMOTE CAREMANAGEMENT SYS K093379

2007-1200

2010-4560

NEPHROS, INC - DSU DUAL STAGE ULTRAFILTER K090885

NIKKISO CO - DBB-05 HEMODIALYSIS DELIVERY SYS

K061519

DAVITA CLINICAL RESEARCH - DBB-05 HEMODIALYSISDELIVERY SYS K023509

ROCKWELL MEDICAL TECHNOLOGIES INC - CITRAPUREK062399

GAMBRO RENAL PRODUCTS - PRISMA SYS K010805

GAMBRO RENAL PRODUCTS - PRISMA SYS R03 10AK062090

GAMBRO - PRISMAFLEX SYS VERSION 3.20 K072093

CanReg, Inc.

WALTERS KLUWER LAW &

BUSINESS

Center for Regulatory Services, Inc.

WASHINGTON INFORMATIONSOURCE

KENDLE REGULATORY AFFAIRS

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

2010-5781

2010-5782

2010-5783

2010-5784

2010-5785

2010-5786

2010-5787

2010-5788

2010-5789

2010-5790

2010-5791

2010-5792

2010-5793

2010-5794

2010-5795

2010-5796

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

CDRH/OMO/DEMO/FOIB/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/


2/65



Total Records: 908

Page 2 of 65



B BRAUN MEDICAL - DIAPACT CRRT K973322

B BRAUN MEDICAL - INTROCAN SAFETY IV CATHETER

K020785

GAMBRO RENAL PRODUCTS - PRISMASATE DIALYSISSOLUTIONS FOR CONTINUOUS RENAL REPLACEMENTTHERAPY K072908

HEMAMETRICS - CRIT-LINE MONITOR III TQA K011741


2010-5276 - REQUEST LTR

2010-5318, 2010-5319 REQUEST LTR


SUN - SUATRIPAN SUCCINATI QUALITY CONTROLPROGRAM FOR DRUGS MADE OUTSIDE OF USA

GLENMARK - GABAPENTIN QUALITY CONTROL PROGRAMFOR DRUGS MADE OUTSIDE OF USA

PARK DAVIS - LYRICA QUALITY CONTROL PROGRAM FOR

DRUGS MADE OUTSIDE USA

PHOENIX EPIDURAL & SPINAL NEEDLES - K990519

SOMAXON PHARMACEUTICALS INC - SILENOR (DOXEPINEHCL) NDA 22-036 RVWS, ADMINISTRATIVE RECS

PQ CORP, UTICA, IL - EIRS 2/08, 4/26/10 TO 5/6/10

DRUG LISTING RECS FOR OTC PRODUCTS - UPDATEDVERSION

JOAN STITT (UG2DC-16)

LOAN STITT (UG2CD-16)

JOAN STITT (UG2CD-16)


SANJIV KUMAR

COLLEEN GRACE DONOFRIO

MARCIA D HOWARD

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

MERCK & CO., INC.

MERCK & CO., INC.

MERCK & CO., INC.

MERCK & CO., INC.

BRODBECK, TOM

BRODBECK, TOM

BRODBECK, TOM

MYCO MEDICAL

BLUMHARDT, CHRISTINE

BABST CALLAND CLEMENTS ETAL

CONSUMER HEALTH

INFORMATION CORPORATION

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/02/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

08/30/2010

2010-5797

2010-5798

2010-5799

2010-5800

2010-5801

2010-5802

2010-5803

2010-5804

2010-5805

2010-5806

2010-5807

2010-5808

2010-5809

2010-5810

2010-5811

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

CDRH/OMO/DEMO/FOIB/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

ORA/CE-FO/CHI-DO/CCB/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/


3/65



Total Records: 908

Page 3 of 65



PUBLICATIONS HHS-ODPHP-2010-01, 00-4084, 01-3290,ETC

DKTS FDA-1997-P-0537, FDA-1989-P-0008, FDA-1999-D-0061, ETC.

BIOVAIL CORP - EIRS, 483S, WARNING LTRS ETC 2009-2010

CEPHALON INC - EIRS, 483S, WARNING LTRS, ETC 2009-2010

ENDO PHARMACEUTICALS - EIRS, 493S, WARNING LTRSETC 2009-2010

PAUL W FRANCK, FRANCK'S LAB INC, FRANCK'SPHARMACY INC, ETC - INVESTIGATION CORR, RPTS,WARNING LTR, ETC 4/19/09

BURZYNSKI RESEARCH INSTITUTE (BRI), HOUSTON, TX -EIRS, 483S, & CO RESP12/3-10/08

TAPENTADOL - ISRS 6439998, 6301260, 6314426, ETC

K073515

HI-TECH PHARMACAL, AMITYVILLE, NY - EIRS, 483S, CORESP 10/21/03 TO 12/09

K061041

k953076

CICELY PARSEGHIAN

GRAIG SUVANNAVEJH

GRAIG SUVANNAVEJH

GRAIG SUVANNAVEJH

THOMAS WADE YOUNG

ELIZABETH WOECKNER

VIRGINIA SMITH

VIRGINIA SMITH

WALTER E CHALKLEY

VIRGINIA SMITH

VIRGINIA SMITH

WILLIAMS FDC# E20560, LESTERL

FOLEY HOAG LLP

JEFFERIES & CO

JEFFERIES & CO

JEFFERIES & CO

DEMPSEY & ACCOCIATES PA

CITIZENS FOR RESPONSIBLECARE & RESEARCH



THOMSON REUTERS



08/02/2010

08/02/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/30/2010

08/30/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

2010-5812

2010-5813

2010-5814

2010-5815

2010-5816

2010-5817

2010-5818

2010-5819

2010-5820

2010-5821

2010-5822

2010-5823

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OC/OM/OMP/DDM/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

ORA/CE-FO/BLT-DO/CB/

ORA/SE-FO/SJN-DO/SJCB/

ORA/SW-FO/DEN-DO/COMP/

ORA/CE-FO/PHI-DO/PCB/

ORA/SE-FO/FLA-DO/FCB/

ORA/OCI/

ORA/SW-FO/DAL-DO/COMPLIANCE/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDRH/OMO/DEMO/FOIB/

ORA/NE-FO/NYK-DO/NYDCB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

CDRH/OMO/DEMO/FOIB/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/


4/65



Total Records: 908

Page 4 of 65



K013829

RIVER'S EDGE PHARMACEUTICALS, SUWANEE, GA - EIRS,483S, CO RESP 7/13/09 TO 8/12/09

K001323

K994308

SANOFI PASTEUR, MARCY L'ETOILE, FRANCE - 483S,CORR, CO RESP 3/15/10 TO 4/2/10

SANOFI PASTEUR, MARCY L'ETOLILE, FRANCE - EIR,CORR, CO RESP 3/15/10 TO 4/2/10

LUPIN LIMITED, MUMBAI, INDIA - 483, CORR, CO RESP5/14/10

LUPIN LIMITED, MUMBAI, INDIA - EIR, CORR, CO RESP5/14/10

CANGENE CORP, WINNIPEG, CANADA - 483, CORR, CORESP 4/12-22/10

CANGENE CORP, WINNIPEG, CANADA - EIR, CORR, CORESP 4/12-22/10

AMPAC FINE CHEMICALS, LLC, RANCH CORDOVA, CA -483, CORR, CO RESP 2/9-19/10

AMPAC FINE CHEMICALS LLC, RANCH CORDOVA, CA - EIR,CORR, CO RESP 2/9-19/10

ABBOTT DIABETES CARE, ALAMEDA, CA - 483. CORR. CORESP 3/10

VIRGINIA SMITH

WALTER E CHALKLEY

VIRGINIA SMITH

VIRGINIA SMITH

MARY E HANSEN

MARY E HANSEN

MARY E HANSEN

MARY E HANSEN

MARY E HANSEN

MARY E HANSEN

MARY E HANSEN

MARY E HANSEN

MARY E HANSEN


THOMSON REUTERS












08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

2010-5824

2010-5825

2010-5826

2010-5827

2010-5828

2010-5829

2010-5830

2010-5831

2010-5832

2010-5833

2010-5834

2010-5835

2010-5836

CDRH/OMO/DEMO/FOIB/

ORA/SE-FO/ATL-DO/ACB/

CDRH/OMO/DEMO/FOIB/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

CDRH/OMO/DEMO/FOIB/

CBER/OCTMA/DDOM/ALFB/


CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/



ORA/P-FO/SAN-DO/SFCB/




5/65



Total Records: 908

Page 5 of 65



ABBOTT DIABETES CARE, ALAMEDA, CA - EIR, CORR, CORESP 3/10

2010-4460

GLP INSPS - 483S 2008, 2009

DRUG MFG PLANTS DATABASE

DOMESTIC & FOREIGN INSPS FOR DRUG COMPANIES,BIORESEARCH MONITORING (BIMO) INSPS 7/1-30/10

KEMIRA OYJ OF FINLAND - FAP 2258

GMP INSPS 12/31/09-6/30/10

POM WONDERFUL - CO RESP 3/17/10

JOHN J MURPHY (SOUTHWESTERN RESEARCH INC),BEVERLY HILLS, CA - EIRS, 483S, CO RESP 6/30/05

ENTRY #FF1203575-5 - LAB RPT

DKT 1978N-036L

HEPARIN - NDC

GLIPIZIDE, AMLODIPINE BESYLATE, PROPANOLOL, ETC -AERS

NEPHROS INC - HEMODIAFILTRATION (HDF) REJECTIONRECS

ELI LILLY & CO - CYMBALTA (DULOXETINE) FOIAREQUESTS

MARY E HANSEN

FRAN KOCH

ROBIN GUY

CATHERINE LARKIN

MARGARET R NAPPI

KRISTI O SMEDLEY PHD

BILL MARTIN

LORREN WALKER

VIRGINIA SMITH

JACK A KRAMER ESQ

COLLEEN M DURRAN

ROBERT P CHARROW


INFORMATION ACCESS

ROBIN GUY CONSULTING LLC

BLOOMBERG NEWS

LACHMAN CONSULTANTSERVICES, INC.


ELI LILLY & CO

SCHRAMM WILLIAMS &ASSOCIATES INC


DEKO INTERNATIONAL CO LTD

TAUBER WESTLAND & BENNETTPC

Doe J

MOSLEY, ALLIE

FRESENIUS MEDICAL CARE

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

2010-5837

2010-5838

2010-5839

2010-5840

2010-5841

2010-5842

2010-5843

2010-5844

2010-5845

2010-5846

2010-5847

2010-5848

2010-5849

2010-5850

2010-5851


OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/ORA/ORM/

ORA/ORM/

ORA/ORM/

CFSAN/OCD/EOS/

CVM/OCD/

CFSAN/OCD/EOS/

ORA/ORM/

CFSAN/OCD/EOS/

ORA/P-FO/LOS-DO/LACB/


OM/OMP/DODM/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDRH/OMO/DEMO/FOIB/

OM/OSS/OPILS/DFI/


6/65



Total Records: 908

Page 6 of 65



CLOSED FOI REQUESTS 7/26-30/10

SCHEIN PHARMACEUTICAL CO - PRODUCTION &

MARKETING OF GENERIC DRUGS 1967 TO 1985

K030468

MYLAN PHARMACEUTICAL CO - PRODUCTION &MARKETING OF GENERIC DRUGS 1967 TO 1985

K033017

K090348

BOLAR PHARMACEUTICAL CO - PRODUCTION &MARKETING OF GENERIC DRUGS 1967 TO 1985

PROCTER & GAMBLE MANUFACTURA S DE R L DE CV -CREST CALCI-DENT MFR REGISTRATION NUMBER

ABBOTT LABORATORIES DE MEXICO S A DE CV -PEDIALYTE MFR REGISTRATION NUMBER

W L GORE & ASSOCIATES INC - GORE PRECLUDE VESSELGUARD K061727

2010-5416

ESC MEDICAL SYSTEMS LTD - DERMA 20 LASER SYSK964253

ENDUIS ATAVI SYS - K022199: METRX SYS - K02931;KNIGHT ENDOSCOPIC SYSTEM SET - K000046, ETC

CHEK-MED SYSTEMS INC - SPOT ENDOSCOPIC MARKERK993951

DEPUY ORTHOPAEDICS - MDR 181890-2009-02141

CECELIA FRENCH

JEREMY A GREENE MD PHD

JOCELYN KERSTEN


JOCELYN KERSTEN

JOCELYN KERSTEN


NICHOLAS JUNGBLUTH

ELENA HOWELL

SRIKANTH K REDDY

STACIE GEFFNER-ATIYA

JOSEPH R CARNICELLA

JOSEPH E KOLAR

GREENBERG TRAURIG LLP

CanReg, Inc.

HARVARD UNIV DEPT OF THEHISTORY OF SCIENCE

EKOS CORP


EKOS CORP

EKOS CORP


CECENA, TERESA

CECENA, TERESA

M SQUARED ASSOCIATES INC

HOGAN LOVELLS US LLP

GOODWIN PROCTER LLP

VISION SCIENCES INC

PICADIO SNEATH MILLER ET AL

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

09/17/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

2010-5852

2010-5853

2010-5854

2010-5855

2010-5856

2010-5857

2010-5858

2010-5859

2010-5860

2010-5861

2010-5862

2010-5863

2010-5864

2010-5865

2010-5866

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/FDAHO/

CDRH/OMO/DEMO/FOIB/

OM/OSS/OPILS/FDAHO/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

OM/OSS/OPILS/FDAHO/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDRH/OMO/DEMO/FOIB/

OM/OSS/OPILS/DFI/OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/


7/65Thursday September 9 2010 4:28 PM


Total Records: 908

Page 7 of 65



NOVARTIS FARMACEUTICIA S A DE C V - LAMISIL CREAMMFR REGISTRATION NUMBER

SCHERING-PLOUGH S A DE C V - DESENFRIO D MFR

REGISTRATION NUMBER

IOVATE, HYDROXYCUT, SMARTBURN, ETC - AERS

DIATOMACEOUS EARTH TABS - RECS

2010-3606

2010-3619

2010-3656

MEDICIS PHARMACEUTICAL CORP - EIRS, 483S, CO RESP,ETC 2009-2010

FOREST LABORATORIES INC - EIRS, 483S, CO RESP, ETC2009-2010

ELAN CORPORATION PLC - EIRS, 483S, CO RESP, ETC2009-2010

DKT 2005-P-0082

JAZZ PHARMACEUTICALS INC - EIRS, 483S, CO RESP, ETC2009-2010

PAR PHARMACEUTICAL CO - EIRS, 483S, CO RESP, ETC

2009-2010

JOHN DOHERTY

INRE SZENTIPETERI MD

WALTER E CHALKLEY

WALTER E CHALKLEY

WALTER E CHALKLEY

GRAIG SUVANNAVEJH PHD



BOBBY SCHOCHET



BAIZER & KOLAR PC

CECENA, TERESA

CECENA, TERESA

IOVATE HEALTH SCIENCESRESEARCH INC

EGIS PHARMACEUTICALS PLC

THOMSON REUTERS

THOMSON REUTERS

THOMSON REUTERS

JEFFERIES & CO

JEFFERIES & CO

JEFFERIES & CO

OLSSON FRANK WEEDATERMAN BODE MATZ

JEFFERIES & CO

JEFFERIES & CO

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

2010-5867

2010-5868

2010-5869

2010-5870

2010-5871

2010-5872

2010-5873

2010-5874

2010-5875

2010-5876

2010-5877

2010-5878

2010-5879

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CFSAN/OCD/EOS/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

CDER/ORP/DIDP/

CDER/ORP/DIDP/OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OC/OM/OMP/DDM/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/




Total Records: 908

Page 8 of 65



OREXIGEN THERAPEUTICS INC - EIRS, 483S, CO RESP,ETC 2009-2010

SOMAXON PHARMS - EIRS, 483S, CO RESP, ETC 2009-2010

JASON POZNER MD, BOCA RATON, FL - EIR, 483, CO RESP2/12 TO 3/24/10

MEDEFIL INC, GLENDALE HEIGHTS, IL - EIR, 483, CO RESP12/09 TO 2/10

INDEPENDENT REVIEW CONSULTING, IRB, CORTEMADERA, CA - EIR, 483, CO RESP 2/8-25/10

MEDCENTRAL HEALTH SYS IRB, MANSFIELD, OH - EIR, 483,CO RESP 3/22-31/10

MICROSURGICAL TECHNOLOGY, REDMONT, WA - EIR, 483,CO RESP 6/3-11/09

PATRICK NEMECHEK, OVERLAND PARK, KS - EIR, 483, CORESP 2/22/10-3/22/10

NORTH MEMORIAL MEDICAL CTR IRB, ROBBINSDALE, MN -EIR, 483, CO RESP 3/22-30/10

WARNER-CHILCOTT - EIR, 483, WARNING LTS, ETC 2009-2010

VANDA PHARMACEUTICALS INC - EIR, 483, WARNINGLTRS, ETC 2009-2010

VALEANT PHARMACEUTICALS INTERNATIONAL - EIR, 483,WARNING LTRS, ETC 2009-2010

ALLERGAN INC - EIR, 483, WARNING LTS, ETC 2009-2010

PATHEON INC - EIR, 483, WARNING LTRS, ETC 2009-2010



WALTER E. CHALKLEY

WALTER E. CHALKLEY

WALTER E. CHALKLEY

WALTER E. CHALKLEY

WALTER E. CHALKLEY

WALTER E. CHALKLEY

WALTER E. CHALKLEY

GRAIG SUVANNAVEJH, PhD





JEFFERIES & CO

JEFFERIES & CO

THOMSON REUTERS

THOMSON REUTERS

THOMSON REUTERS

THOMSON REUTERS

THOMSON REUTERS

THOMSON REUTERS

THOMSON REUTERS

JEFFERIES & CO

JEFFERIES & CO

JEFFERIES & CO

JEFFERIES & CO

JEFFERIES & CO

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

09/07/2010

08/31/2010

2010-5880

2010-5881

2010-5882

2010-5883

2010-5884

2010-5885

2010-5886

2010-5887

2010-5888

2010-5889

2010-5890

2010-5891

2010-5892

2010-5893

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/




ORA/CE-FO/CIN-DO/CCB/

ORA/P-FO/SEA-DO/SCB/

ORA/SW-FO/KAN-DO/COMP/

ORA/CE-FO/MIN-DO/MCB/








CDER/ORP/DIDP/

CDER/ORP/DIDP/







Total Records: 908

Page 9 of 65



SANDOZ - EIR, 483, WARNING LTRS, ETC 2009-2010

SALIX PHARMACEUTICALS INC - EIR, 483, WARNING LTRS,ETC 2009-2010

MYLAN INC - EIR, 483, WARNING LTS, ETC 2009-2010

IMPAX LABORATORIES INC - EIR, 483, WARNING LTS, ETC2009-2010

WATSON PHARMACEUTICALS INC - EIR, 483, WARNINGLTS, ETC 2009-2010

TEVA PHARMACEUTICAL INDUSTRIES LTD - EIR, 483,WARNING LTS, ETC 2009-2010







JEFFERIES & CO

JEFFERIES & CO

JEFFERIES & CO

JEFFERIES & CO

JEFFERIES & CO

JEFFERIES & CO

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/03/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

08/31/2010

2010-5894

2010-5895

2010-5896

2010-5897

2010-5898

2010-5899

CDER/ORP/DIDP/

CDER/ORP/DIDP/

ORA/CE-FO/NJ-DO/NJCB/








ORA/NE-FO/NWE-DO/NWECB/


















ORA/CE-FO/PHI-DO/PCB/ORA/NE-FO/NYK-DO/NYDCB/


10/65



Total Records: 908

Page 10 of 65



RISK-BASED MODEL FOR PRIORITISING CGMP

INSPECTIONS OF PHARMACEUTICAL MANUFACTURINGSITES - A PILOT RISK RANKING MODEL 9/04

PROFESSIONAL DISPOSABLES INC, NICE-PAK PRODUCTSINC - CHLORA SCRUB CORR, RECS 2004 TO PRESENT

COMPANIES THAT PRODUCE OR USE ANTI-SEALINGAGENTS FOR THE PRODUCTION OF ANIMAL FEED - LTRS,RECS

SMALL MANUFACTURERS ASSOCIATION FOR THEREASONABLE TREATMENT OF TOBACCO (SMARTT)COALITION - MTG MINS 6/30/10

RLD (TRANDATE) NDA 18-716 - LBLG

ZYDUS PHARMS USA INC - MYCOPHENOLATE MOFETILNDA 65-433, NDA 65-477 BIOEQV STUDY

VANCOCIN HCL CAPS NDA 50-606 - APRVL RECS

OPTIRAY IOVERSOL INJ - AERS

CMPLNT #115486

CMPLNT #115330

GENTLEWAVES CONSUMER LED PHOTOMODULATION -K062991

STAR-LITE LM MODEL SI8809 - K092460

OMNILUX NEW-U - K072459

MICHELE R HALL

GERALDINE E EDENS

J BENNEVILLE HAAS ESQ

DEBORAH GOFF

PAMELA A JACOBSON

BLESSY JOHNS

KAREN G KELSEN

ROBERT WAGNER

ROBERT WAGNER

ROBERT WAGNER

GEYMAN, CATHERINE

SONNENSCHEIN NATH &ROSENTHAL LLP

MCKENNA LONG & ALDRIDGELLP

LATHAM & WATKINS LLP

SANDOZ INC

UNIV OF MINNESOTA COLLEGEOF PHARMACY

AUROLIFE PHARMA LLC

MAZIE SLATER KATZ ET AL

KING, CLARICE

MALKIN, KAREN A

AEGIS REGULATORY INC



08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

2010-5900

2010-5901

2010-5902

2010-5903

2010-5904

2010-5905

2010-5906

2010-5907

2010-5908

2010-5909

2010-5910

2010-5911

2010-5912




CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/


CVM/OCD/

CTP/OD/

CTP/OD/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/



CDRH/OMO/DEMO/FOIB/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

OM/OSS/OPILS/DFI/


11/65



Total Records: 908

Page 11 of 65



SPL RECS

MYOVIEW NDA 20-372 - FOI REQUESTS 1/07 TO PRESENT

CLOSED FOI REQUESTS 7/26/10-8/1/10

FRANCIS PIEN (INTERNAL MEDICINE & INFECTIOUSDISEASES), HONOLULU, HI - EIR, 483, CO RESP 1/25/10

ORTHO MCNEIL-JANSSEN PHARMACEUTICALS INC, SANGERMAN, PR - EIR, 483, CO RESP 6/8/09

MERCK & CO INC - PROQUAD (MEASLES, MUMPS,RUBELLA & VARICELLA VIRUS VACCINE) VAERS 7/1-31/10

MERCK & CO INC - ROTATEQ (ROTAVIRUS VACCINE)VAERS 7/1-31/10

MERCK & CO INC - GARDASIL (HPV VACCINE) VAERS 7/1-31/10

MERCK & CO INC - ISENTRESS (RALTEGRAVIR) VAERS 7/1-31/10


CLOSED FOI REQUESTS 7/1-31/10

DR JELENA KUNOVAC (EXCELL RESEARCH), OCEANSIDE,CA - EIR, 483, CO RESP 4/21/08

ENTRY # 22119274458

TEVA - MYCOPHENOLATE MOFETIL ANDA 65-491, ANDA

65-457 BIOEQV STUDY

MARK P BAYER

LAURIE C STEELE

ANGELIA D SLAYTON

ANGELIA D SLAYTON







VIRGINIA SMITH

SHERMAN L. MAH

PAMELA A. JACOBSON

REED TECHNOLOGY ANDINFORMATION SERVICES INC

REED SMITH LLP

FOI SERVICES INC



MERCK & CO., INC.

MERCK & CO., INC.

MERCK & CO., INC.

MERCK & CO., INC.

MERCK & CO., INC.

MERCK & CO., INC.


CERTIFIED LABORATORIES INC

UNIV OF MINNESOTA COLLEGE

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

2010-5913

2010-5914

2010-5915

2010-5916

2010-5917

2010-5918

2010-5919

2010-5920

2010-5921

2010-5922

2010-5923

2010-5924

2010-5925

2010-5926

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/






CDER/ORP/DIDP/

CDER/ORP/DIDP/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/



CDER/ORP/DIDP/

CDER/ORP/DIDP/

Di l FOI R L D f 08 0 20 0 08 3 20 0 R


12/65



Total Records: 908

Page 12 of 65



STRIDES ARCOLAB LTD - MYCOPHENOLATE MOFETILANDA 90-055, ANDA 90-456 BIOEQV STUDY

SANDOZ - MYCOPHENOLATE MOFETIL ANDA 65-379, ANDA65-451 BIOEQV STUDY

ROXANE - MYCOPHENOLATE MOFETIL ANDA 65-410,ANDA 65-413 BIOEQV STUDY

MYLAN - MYCOPHENOLATE MOFETIL ANDA 65-520, ANDA65-521 BIOEQV STUDY

ENDO PHARMS - MYCOPHENOLATE MOFETIL ANDA 90-111, ANDA 90-606 BIOEQV STUDY

APOTEX - MYCOPHENOLATE MOFETIL ANDA 90-419, ANDA90-499 BIOEQV STUDY

ACCORD HLTHCARE - MYCOPHENOLATE MOFETIL ANDA90-402, ANDA 65-416 BIOEQV STUDY

TACROLIMUS ANDA 90-402 - BIOEQV STUDY

TACROLIMUS ANDA 65-461 - BIOEQV STUDY

WARNING LTRS 8/310

DR REDDYS LABS, HYDERABAD, INDIA - EIRS, 483S 1/03 TOPRESENT

MERZ PHARMS - NAFTIN CREAM NDA 19-5992/S001,002APRVL RECS

MERS PHARMS - NAFTIN GEL N-19-356 APRVL RECS

KELLOGG - CEREAL RECALL 6/10

SANDOZ - ENOXAPARIN SODIUM ANDA 77-857 APRVL

RECS

PAMELA A. JACOBSON

PAMELA A. JACOBSON

PAMELA A. JACOBSON

PAMELA A. JACOBSON

PAMELA A. JACOBSON

PAMELA A. JACOBSON

PAMELA A. JACOBSON

PAMELA A. JACOBSON

PAMELA A. JACOBSON

OF PHARMACY




UNIVERSITY OF MINNESOTA






Hyman, Phelps & McNamara, P.C.

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

Doe J

FOI SERVICES INC

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/04/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/01/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

2010-5927

2010-5928

2010-5929

2010-5930

2010-5931

2010-5932

2010-5933

2010-5934

2010-5935

2010-5936

2010-5937

2010-5938

2010-5939

2010-5940

2010-5941

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/


CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CFSAN/OCD/EOS/

ORA/CE-FO/DET-DO/DCB/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

Di l FOI R t L D t f 08/01/2010 t 08/31/2010 R t


13/65



Total Records: 908

Page 13 of 65



POM WONDERFUL - POMEGRANATE JUICE RESP TOWARNING LTR CORR, MEMOS, MINS, ETC 2/23/10

HEMOLYTIC TRANSFUSION - RPT

BAYER MATERIAL SCIENCE AG - FCN 695

MEDAPPS 2.0 - K083862

KLINGE CHEMICALS LTD, GLASGOW, GB - 483S 6/1-30/10

CILAG AG, SCHAFFHAUSEN, CH, TAIWANFUJIMOTOCHEMICAL, MIAOLI, TW, LONZA AG, VISP, CH,ETC - 483S 6/1-30/10

LIST OF BIOLOGICS & MEDICAL DVC MFG FACILITIES INTHE USA & OUTSIDE THE USA 7/1-30/10

HOSPIRA, ROCKY MOUNT, NC - 483S 6/1-30/10

NOXELL CORP, HUNT VALLEY, MD; RHODIA, BALTIMORE,MD; EASTERN CRANIAL AFFILIATES, ARLINGTON, VA, ETC -483S 6/1-30/10

BIONIX DEVELOPMENT CORP, TOLEDO, OH - 483S 6/1-30/10

MEDIMMUNE, MEDICAL PRODUCTS LABS, PHILADELPHIA,

PA; SPRAY-TEK, BETHLEHEM, PA, ETC - 483S 6/1-30/10

ANCHOR PRODUCTS CO, ADDISON IL; OHIO MEDICALCORP, GURNEE, IL - 483S 6/1-30/10

ISO-TEX DIAGNOSTICS, FRIENDSWOOD, TX; MEDROSYSTEMS, MCKINNEY, TX, DIVERSIFIED DIAGNOSTICPRODUCTS, HOUSTON, TX, ETC - 483S 6/1-30/10

HOLLISTER STIER LABS, SPOKANE, WA; PARKS MEDICALELECTRONICS, ALOHA OR; VERATHON, BOTHELL, WA -483S 6/1-30/10

REGENERATIVE SCIENCES, BROOMFIELD, CO, AMERICANBIOTECH LABS, ALPINE, UT - 483S 6/1-30/10

SIGMA-TAU PHARMASOURCE, INDIANAPOLIS, IN; JARDON

LISA PETERSON

APRIL HOLLIS

APRIL HOLLIS

APRIL HOLLIS

APRIL HOLLIS

APRIL HOLLIS

APRIL HOLLIS

APRIL HOLLIS

APRIL HOLLIS

APRIL HOLLIS

APRIL HOLLIS

APRIL HOLLIS

APRIL HOLLIS

FOI SERVICES INC

Doe J

FOI SERVICES INC

QA CONSULTING INC

FDA NEWS

FDA NEWS

FDA NEWS

FDA NEWS

FDA NEWS

FDA NEWS

FDA NEWS

FDA NEWS

FDA NEWS

FDA NEWS

FDA NEWS

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

2010-5942

2010-5943

2010-5944

2010-5945

2010-5946

2010-5947

2010-5948

2010-5949

2010-5950

2010-5951

2010-5952

2010-5953

2010-5954

2010-5955

2010-5956

2010-5957

CFSAN/OCD/EOS/


CFSAN/OCD/EOS/

CDRH/OMO/DEMO/FOIB/

ORA/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

ORA/ORM/










Di l FOI R t L D t f 08/01/2010 t 08/31/2010 R t


14/65



Total Records: 908

Page 14 of 65



EYE PROSTHETICS, SOUTHFIELD, MI; GUNNELL,MILLINGTON, MI - 483S 6/1-30/10

ALL MED SERVICES OF FLORIDA, TAMPA, FL; WINCO,OCALA, FL; CARE TECH INDUSTRIES, SEMINOLE, FL, ETC -483S 6/1-30/10

BRISTOL MYERS SQUIBB, HUMACAO, PR; ORTHOBIOLOGICS, MANATI, PR; ST JUDE MEDICAL, ARECIBO, PR,ETC - 483S 6/1-30/10

CEREC OPTI SPRAY - K080882

VITALWEAR, SOUTH SAN FRANCISCO, CA; BIOCHECK,FOSTER CITY, CA; TERARECON, SAN MATEO, CA, ETC -483S 6/1-30/10

DEXIS SOFTWARE - K090431

DAKOTA LABS, MITCHELL, SD; MINNTECHCORP,PLYMOUTH, MN; XTEN INDUSTRIES,KENOSHA, WI,ETC - 483S 6/1-30/10

AXELLIA PHARMACEUTICALS APS (ALPHARMA SPS),COPENHAGEN, DENMARK - EIRS 5/2-6/05

AXELLIA PHARMACEUTICALS APS, OSLO, NORWAY - EIRS6/16-23/08

TIOTROPIUM - IND 101,608 RECS

NOVO NORDISK A/S, NORDISK, INC - VICTOZA SUPPLDRUG APPL, APRVL, RVWS, ETC

ADEZA BIOMEDICAL - GESTIVA 17 ALPHA-HYDROXPROGESTERONE CAPROATE INJ NDA 21-945APPROVABLE LTR 10/06, RESP LTR 1/09, ETC

VIACELL INC, CAMBRIDGE, MA; VIACORD (A PERKIN ELMERCO); VIACORD PROCESSING LABORATORY, HEBRON, KY -EIRS, 483S 1/07 TO 12/09

FISCHER WALLACE LABS, NEW YORK, NY - 483S 6/1-30/10

P&G PET FOOD PLANT, LEWISBURG, OH - EIRS,ANALYTICAL TEST, SPLS, ETC 5/21/10, 7/7--8/10

GC HANFORD MFG, SYRACUSE, NY; QUADRISCISER, KT

APRILL HOLLIS

APRIL HOLLIS

JON BROCKMAN

APRIL HOLLIS

CLAUDE BERTHOIN

APRIL HOLLIS

RICHARD YOUNGSTROM

RICHARD YOUNGSTROM

ELLIOT ISRAEL MD

SARAH M FRAZIER

LAURA PANK

APRIL HOLLIS

RACHAEL Y PILEGGI

APRIL HOLLIS

FDA NEWS

FDA NEWS

FDA NEWS

IOS TECHNOLOGIES INC

FDA NEWS

DENTERPRISE

FDA NEWS

NYCOMED US INC

NYCOMED US INC

HARVARD MEDICAL SCHOOL

BERG & ANDROPHY

AUGUSTINE, MARK E

CBR SYSTEMS INC

FDA NEWS

P&G

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

2010-5958

2010-5959

2010-5960

2010-5961

2010-5962

2010-5963

2010-5964

2010-5965

2010-5966

2010-5967

2010-5968

2010-5969

2010-5970

2010-5971

2010-5972



CDRH/OMO/DEMO/FOIB/


CDRH/OMO/DEMO/FOIB/


CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/


CDER/ORP/DIDP/





ORA/SE-FO/NOL-DO/NOCB/



15/65



Total Records: 908

Page 15 of 65



MEDICAL, KNOXVILLE, TN, ETC - 483S 6/1-30/10

MEDTOX LABORATORIES INC - EIRS 4/5-9/10

RUTHERFORD CHEMICALS, BAYONNE, NJ; ACTAVIS

ELIZABETH, ELIZABETH, NJ; TRI-MED LABS, SOMERSET,NJ, ETC - 483S 6/1-30/10

PCI SYNTHESIS, NEWBURYPORT, MA; PROMETHEUSGROUP, DOVER, NH; ONCO LAB, BOSTON, MA, ETC - 483S6/1-30/10

MCGRUFF PHARMS, SANTA ANA, CA; FNC MEDICAL CORP,VENTURA, CA; BOIRON, SIMI VALLEY, CA, ETC - 483S 6/1-30/10

HEALTHCARE EQUIPMENT & SUPPLY, PERRYVILLE, MO;HOME MEDICAL SUPPLY, POPLAR BLUFF, MO; BAYERHEALTH CARE, SHAWNEE, KS, ETC - 483S 6/1-30/10

OPTILASA SA, MADRID, ES; BIOTECH INTERNATIONAL,

SALON DE PROVENCE; HEALTH AND LIFE, CHUNG HOCITY, TW, ETC - 483S 6/1-30/10

DEPUY ORTHOPAEDICS INC - COMPARTMENTAL KNEEPROSTHESIS SYS K061648

DEPUY ORTHOPAEDICS INC - DEPUY GCK FEMORAL ANDTIBIAL COMPONENTS K070849

DEPUY ORTHOPAEDICS INC - SIGMA HIGH PERFORMACEUNITY KNEE RESURFACING SYS K070267

INTEGRATED SURGICAL SYSTEMS INC - DIGIMATCHROBODOC SURGICAL SYS K072629

HOWMEDICA OSTEONICS CORP - STYKERCOMPARTMENTAL KNEE SYS K052917

BIOMET MANUFACTURING CORP - VITAMIN EACETABULAR LINERS (E-POLY) K050327

BIOMET MANUFACTURING CORP - VITAMIN EPOLYETHYLENE TIBIAL BEARINGS K080528

GULF COAST OIL SPILL - PUBLIC HEALTH HAZARD RECS

STEVE BONIN

APRIL HOLLIS

APRIL HOLLIS

APRIL HOLLIS

APRIL HOLLIS

APRIL HOLLIS

DIONNE SANDERS

DIONNE SANDERS

DIONNE SANDERS

DIONNE SANDERS

DIONNE SANDERS

DIONNE SANDERS

DIONNE SANDERS

STUART H SMITH

FDA NEWS

MEDTOX LABORATORIES INC

FDA NEWS

FDA NEWS

FDA NEWS

FDA NEWS

FDA NEWS

MAKO SURGICAL CORP

MAKO SURGICAL CORP

MAKO SURGICAL CORP

MAKO SURGICAL CORP

MAKO SURGICAL CORP

MAKO SURGICAL CORP

MAKO SURGICAL CORP

SMITH STAG LLC

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

2010-5973

2010-5974

2010-5975

2010-5976

2010-5977

2010-5978

2010-5979

2010-5980

2010-5981

2010-5982

2010-5983

2010-5984

2010-5985

2010-5986

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/





CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CFSAN/OCD/EOS/

OC/OM/OSS/OAGS/

ORA/

OC/OCM/EMOPS/



16/65



Total Records: 908

Page 16 of 65



SPL 634801, 625867, 625869 - ANALYTICAL RESULTS

SYNTEX DENTAL PRODUCTS - STERILE WATER SYSK823230

BOSTON SCIENTIFIC - WALLFLEX BILIARY RX PARTIALLYCOVERED STENT SYS K083374

WEIGAO, SHANDONG PROVICE, CHINA - EIRS. 483S 2002TO PRESENT

BOSTON SCIENTIFIC - WALLFLEX BILIARY RX FULLY

COVERED STENT SYS K083627

DKT FDA-2010-D-0277

NAVITRACK SYS-OS KNEE UNIVERSAL MODEL PRO-05002- K060335

DIEGENE CORP, GAITHERSBURG, MD - HYBRID CAPTURE2 HIGH-RISK HPV DNA TEST P890064/S014 RECS

K953414, K951483, K980066, ETC

BECKMAN COULTER - ACCU TNI TEST KIT COMM 1/1/09 TO

WILLIAM M SLAUGHTER II

ROMAINE BARR

ARTHUR J WARD

NICK LEWIS

SAMANTHA AUTREY

SAMUEL F COIN MD

TEJAS INDUSTRIES

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

ARNOLD & PORTER

REGULATORY & MARKETINGSERVICES INC

ROCHE MOLECULAR SYSTEMS

MICROTEK MEDICAL INC

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/05/2010

08/06/2010

08/06/2010

08/06/2010

08/06/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/02/2010

09/03/2010

09/03/2010

09/03/2010

2010-5987

2010-5988

2010-5989

2010-5990

2010-5991

2010-5992

2010-5993

2010-5994

2010-5995

2010-5996

OC/COS/OES/

OC/COS/OES/

ORA/

ORA/ORO/







OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OC/OM/OEO/


CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

OC/OM/OMP/DDM/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/



17/65



Total Records: 908

Page 17 of 65



8/4/10

STRYKER ORTHOPAEDICS, MAHWAH, NJ - TOTAL KNEEJOINT REPLACEMENT PROSTHESIS K072575

BAYER HEALTHCARE - NEXAVAR (SORAFENIB TOSYLATE)

NDA 21-923 RVWS, ADMINISTRATIVE RECS, APRVL

SLATE PHARMACEUTICALS - RESP TO WARNING LTR3/23/10

CERTOLUZIMAB PERGOL - SUPPLEMENTAL APRVL 5/09

HOT SPRINGS COUNTY MEMORIAL HOSPITAL, WYOMING -EIRS, 483S, WARNING LTRS 1/03 TO PRESENT

ROCKY MOUNTAIN NATURAL MEATS E COLI OUTBREAK -

EMAILS, INVESTIGATIONS, LAB TEST RESULTS, ETC 6/10

BEEBE MEDICAL CENTER, LEWES, DE - HEPARIN MEMOOF INVESTIGATION

GIANT EAGLE INC - CHICKEN OF THE SEA RECALL FORMS6/30/10

MALLINCKRODT BAKER, PHILLIPSBURG, NJ - AUDITSUMMARY 8/14-15/09

ACCURAY, SUNNYVALE, CA - EIR 2/06, 3/06

KREITCHMAN PET CENTER - INVESTIGATIONS, RPTS,FINDINGS 2004, 2008, 2010

DR MIRACLE'S LLC, NEW YORK, NY - HOT GRO HAIR &SCALP CONDITIONER (FEEL IT FORMULA) EIRS, 483S,CMPLNTS, ETC 1/08 TO PRESENT

DKT 1975N-0017

STYRENE-ACRYLONITRILE COPOLYMERS - FCN 680

DIONNE SANDERS

MARY L GEISSLER

MARSH RICKARD BRYAN

ROSE RELVO

PAUL W TRIPP

PATTI WALLER

MARCY B JACK

PATTY HOOGENDAM

JEFF STACHEWICZ

STEVE WAGNER

CHRISTINE M LOCKETTE

STUART A DAVIDSON

MARY MCGUIRE

FIRST MANHATTAN CO

MAKO SURGICAL CORP

Alnylam Pharmaceuticals

MARSH RICKARD & BRYAN PC

OREGON HEALTH SCIENCEUNIVERSITY

LINCARE INC

MARLER CLARK ATTYS

BEEBE MEDICAL CENTER

Giant Eagle

TRILLIUM HEALTH CAREPRODUCTS INC

FOIA GROUP INC

CITIZENS COMMISSION ONHUMAN RIGHTS INTERNATIONAL

CHRISSYS INTERIOR DESIGN

ROBBINS GELLER ET AL

08/06/2010

08/06/2010

08/06/2010

08/06/2010

08/06/2010

08/06/2010

08/06/2010

08/06/2010

08/06/2010

08/06/2010

08/06/2010

08/06/2010

08/06/2010

08/06/2010

09/03/2010

09/03/2010

09/03/2010

09/03/2010

09/03/2010

09/03/2010

09/03/2010

09/03/2010

09/03/2010

09/03/2010

09/03/2010

09/03/2010

09/03/2010

09/03/2010

2010-5997

2010-5998

2010-5999

2010-6000

2010-6001

2010-6002

2010-6003

2010-6004

2010-6005

2010-6006

2010-6007

2010-6008

2010-6009

2010-6010

CDRH/OMO/DEMO/FOIB/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/





OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/







OM/OMP/DODM/

CFSAN/OCD/EOS/



18/65



Total Records: 908

Page 18 of 65



TRIS (2,4-DI-TERT-BUTYLPHENYL) PHOSPHITE - FCN 112,FCN 268, FCN 385, ETC

DEEPWATER HORIZON OIL SPILL - RPTS FROM TESTS OF

FISH FROM THE GULF OF MEXICO

DKTS 1993N-0226, 1992N-0406, 1992P-0441

DKT FDA-1978-N-0022 ( LEGACY 1978N-0301)

DL50 - STRUCTURAL & CONDENSATE FORMULA,ANALYTICAL METHODS, TOXICOLOGICAL STUDIES, ETC

NEEDLE STICK INJURIES IN AMERICAN WORKPLACES -RECS, STATISTICS 1/06 TO PRESENT

MEETING OF THE US-CANADA-MEXICO TRILATERALCOORPERATION CHARTER, CANADA-US-MEXICOCOMPLIANCE INFORMATION GROUP, ETC - MINS

DRAGER MEDICAL SYSTEMS INC, TELFORD, PA - EIR5/20/08-6/2/08

ALOE VERA IN FOOD & BEVERAGES - GRAS NOTICE

SPONSORS, MANUFACTURES OF HUMANPHARMACEUTICALS - RECS

DEHYDRATED PARSLEY GRANULES ENTRY #337-0097306-9 - ANALYSIS RESULTS

BPT PHARMACEUTICALS INC - PROENZY(GLYERALDEHYDE-3-PHOSPHATE DEHYDROGENASE)ORPHAN DRUG APPLICATION

2010-464

ISRS 6553757, 6559149, 6569744, ETC

MARK N DUVALL

JASON DEAREN

I. DAGUISO

RACHELLE LLONTOP

JULIA JARAMIIIO

THOMAS MADDEN

EMILY STEVENSON

KATHY CONACHER

NANCY H MILLER

JANE CAI

LVA WANJEK

DANIEL R GETTS PHD

HELENA HOWELL

JOANNE S HAWANA

EARL MARTIN MCGUIRE PSC

BEVERIDGE & DIAMOND PC

ASSOCIATED PRESS


ARENT FOX LLP

OXITENO

TRANSMEDIA

ALLIANCE FOR NATURALHEALTH USA

DRAGER MEDICAL INC

NSF International

SHANGHAI NEWAY

PHARMACEUTICAL CO LTD

W SCHUMACHER & CO GMBH

TOLERA THERAPEUTICS INC


ARENT FOX LLP

08/06/2010

08/06/2010

08/06/2010

08/06/2010

08/06/2010

08/06/2010

08/06/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

09/03/2010

09/03/2010

09/03/2010

09/03/2010

09/03/2010

09/03/2010

09/03/2010

09/03/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

2010-6011

2010-6012

2010-6013

2010-6014

2010-6015

2010-6016

2010-6017

2010-6018

2010-6019

2010-6020

2010-6021

2010-6022

2010-6023

2010-6024

CFSAN/OCD/EOS/

ORA/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OC/OM/OMP/DDM/

OC/OM/OMP/DDM/

CFSAN/OCD/EOS/


OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/


CFSAN/OCD/EOS/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CFSAN/OCD/EOS/


OC/OSHC/OPD/

CFSAN/OCD/EOS/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

CDER/ORP/DIDP/

CDER/ORP/DIDP/



19/65



Total Records: 908

Page 19 of 65



WYETH CONS - ADVIL CONGESTION RELIEF(IBUPROPHEN, PHENYLEPHRINE HCL) NDA 22-565 APRVLLTR, LBLG, RVWS, ETC

INITRAOCULAR LENSES (IOLS) - MODULATION TRANSFERFUNCTION (MTF) RECS

MERCK & CO INC - VIOXX INVESTIGATION RECS 1992 TOPRESENT

WILLIAM MACFARLAND, HEATHER ROSECRANS -CONFERENCE CALL MEMO TO FILE 8/5/10

ALLIED RESEARCH, MIAMI GARDENS, FL - EIR 8/07

ASI MEDICAL - 483 10/5/09

MULDER HENK MD, ROTTERDAM, NETHERLANDS - EIRS,483S, CO RESP 6/09

STUART A HARLIN, PENSACOLA, FL - EIRS, 483S, CO RESP5/17-21/10

GENTRAC, MIDDLETON, WI - EIR, 483, CO RESP 4/7-16/08

COHAN LYDIA MD, SCOTTSDALE, AZ - EIR, 483, CO RESP6/09

DIVIS LABS, AMEERPET, HYDERABAD, INDIA - EIR, 483, CORESP 9/11-15/00

SANCILIO & COMPANY INC, RIVIERA BEACH, FL - EIRS, 482,483, ETC 12/09 TO PRESENT

GE HEALTHCARE INTEGRATED IT SOLUTIONS,BARRINGTON, IL - EIR, 483, CO RESP 4/15/08-5/13/08

TRIGEN LABORATORIES INC, SAYREVILLE, NJ - EIRS, 482,483, ETC 12/09 TO PRESENT

GE OEC MEDICAL SYSTEMS, SALT LAKE CITY, UT - EIR,483, CO RESP 11/15/04-12/1/04

R/S TECH-PROB SOLUTIONS LLC, TEQUESTA, FL - EIRS,

ANGELIA D SLAYTON

JASON D'AGNENICA

CARMELINA G ALLIS

GILBERT R WEINER

GRANT RAMALEY

WALTER E CHALKLEY

WALTER E CHALKLEY

WALTER E CHALKLEY

WALTER E CHALKLEY

WALTER E CHALKLEY

DANA THOMPSON

WALTER E CHALKLEY

DANA THOMPSON

WALTER E CHALKLEY

DANA THOMPSON


EYE FOUNDATION OF CANADA

STULL STULL & BRODY

Hyman, Phelps & McNamara, P.C.

ADVANCEDPHARMA

ASEPTICO INC

THOMSON REUTERS

THOMSON REUTERS

THOMSON REUTERS

THOMSON REUTERS

THOMSON REUTERS

FULBRIGHT & JAWORSKI LLP

THOMSON REUTERS


THOMSON REUTERS

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

2010-6025

2010-6026

2010-6027

2010-6028

2010-6029

2010-6030

2010-6031

2010-6032

2010-6033

2010-6034

2010-6035

2010-6036

2010-6037

2010-6038

2010-6039

2010-6040

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDRH/OMO/DEMO/FOIB/

CDER/ORP/DIDP/

CDER/ORP/DIDP/


CDRH/OMO/DEMO/FOIB/



CDER/ORP/DIDP/

CDER/ORP/DIDP/




CDER/ORP/DIDP/

CDER/ORP/DIDP/ORA/SE-FO/FLA-DO/FCB/



CDER/ORP/DIDP/

CDER/ORP/DIDP/





20/65



Total Records: 908

Page 20 of 65



482, 483, ETC 12/09 TO PRESENT

USV LTD, MAHARESHTRA, INDIA - EIR, 483, CO RESP 11/7-9/02

IRISYS INC, SAN DIEGO, CA - EIRS, 482, 483, ETC 12/09 TO

PRESENTFOI DAILY LOG 7/26-30/10


CAPTEK SOFTGEL INTERNATIONAL INC, CERRITOS, CA -EIRS, 482, 483, ETC 2/10 TO PRESENT





BOSTON SCIENTIFIC - MODIFIED BILIARY WALLSTENTK000308

ELLMAN INTL - SURGI-MAX K061174

WL GORE - VIABIL BILIARY ENDOPROSTHESIS K081184

2010-5481

2008-975

WALTER E CHALKLEY

DANA THOMPSON

DANA THOMPSON

WILLIAM A OLSON PHD

CECELIA FRENCH


THOMSON REUTERS



FOI SERVICES INC




WOLTERS KLUWER LAW &BUSINESS

CanReg, Inc.

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

2010-6041

2010-6042

2010-6043

2010-6044

2010-6045

2010-6046

2010-6047

2010-6048

2010-6049

2010-6050

2010-6051

2010-6052

2010-6053

2010-6054

CDER/ORP/DIDP/

CDER/ORP/DIDP/


OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/


OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/


OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/



21/65



Total Records: 908

Page 21 of 65



2006-16277

2009-3608

2009-424

2009-4497

2009-4383

2009-7281

2009-7101

CLOSED 510KS 7/-31/10

MERCK RESEARCH LABS - SINGULAIR (MONTELUKASTSODIUM) ISRS 6391169-0, 6403191-6, 6405894-6, ETC

MERCK & CO INC - JANUVIA/JANUMET (SITAGLIPTINPHOSPHATE/SITAGLIPTIN, METFORMIN) ISR 6566020-6

MERCK & CO INC - ISENTRESS (RALTEGRAVIR) ISR6039765-4, 6803233-X

MERCK & CO INC - INVANZ (ERTAPENEM SODIUM) ISR6439823-6

BUCKMAN CO INC - CONTINUUM KNEE SYS K882322; DOW





AMY E BOYD

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

MERCK & CO., INC.

MERCK & CO., INC.

MERCK & CO., INC.

MERCK & CO., INC.

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/09/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/07/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

2010-6055

2010-6056

2010-6057

2010-6058

2010-6059

2010-6060

2010-6061

2010-6062

2010-6063

2010-6064

2010-6065

2010-6066

2010-6067

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/


OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/


OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

CDRH/OMO/DEMO/FOIB/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDRH/OMO/DEMO/FOIB/



22/65



Total Records: 908

Page 22 of 65



CORNING WRIGHT - LACEY PRESS-FIT CONDYLAR TOTALKNEE K864518, WHITESIDE ORTHOLOC MA TOTAL KNEESYS K893252, ETC

ORTHOMET INC - SECOND GERNERATION KNEE SYSK894334, AXIOM TOTAL KNEE SYS K932677; ORTHO

DEVELOPMENT CORP - BALANCED KNEE SYS K994370,ETC

HOSPTIAL FOR SPECIAL SURGERY - INSALL-BURSTEIN II(PR) K935080; INTERMEDICS ORTHOPEDICS - HOFFMANKNE/NATURAL KNEE (PR) K853991; INTERMEDICSORTHOPEDICS - NATURAL-KNEE SYS W/COCR/CSTI (PR)K902335, ETC

ENCORE ORTHOPEDICS INC - FOUNDATION KNEE SYSK92327, K96008; EXACTECH INC - POROUS COATEDCRUCIATED RETAINED FEMORAL COMPONENT (PR)K933526, PORUS COATED POSTERIOR STABILIZEDFEMORAL COMPONET (SR) K935773, ETC

CMPLNT #98980

BIOMET INC - AGC TOTAL KNEE P ROSTHESIS (PR)K833921, FINN KNEE PROSTESIS (PR) K910877, MCKMAXIMUM CONGRUENT KNEE SYSTEM (PR) K915132, ETC

MEDTRONIC INC - SYNCROMED II & CATHETER MDRS,CMPLNTS, VIOLATIONS, ETC

ALLEGHENY GENERAL HOSPITAL - PSEUDOMONASOUTBREAK INVESTIGATION 10/02

DISPOSABLE SYRINGES & DISPOSABLE NEEDLES -K945225

TOTAL KNEE SURGETICS NAVIGATION SYS WITH IBLOCKDOUMENTATION - K090953

KELLOGG CO - CEREAL RECALL 6/10 RECS

AMY E BOYD

AMY E BOYD

AMY E BOYD

CRICKET SPARKS

AMY E BOYD

DANIEL W ERNSBERGER

CHERYL PENROD

SAM KUMAR

WAYNE MORSE

FOLEY HOAG LLP

FOLEY HOAG LLP

FOLEY HOAG LLP

FOLEY HOAG LLP

MOUNTAIN MEADOW HERBS INC

FOLEY HOAG LLP

BEHREND & ERNSBERGER PC

PRIBANIC & PRIBANIC LLC

MYCO MEDICAL

OPERATIV

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

2010-6068

2010-6069

2010-6070

2010-6071

2010-6072

2010-6073

2010-6074

2010-6075

2010-6076

2010-6077

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/


CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

ORA/




ORA/P-FO/SAN-DO/SFCB/ORA/P-FO/SEA-DO/SCB/




CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CFSAN/OCD/EOS/



23/65



Total Records: 908

Page 23 of 65



SURGETIC ORTHO KNEELOGICS NAVIGATION SYS -K031196

NAVITRACK SYS OS KNEE UNIVERSAL - K06336

EPSILON-POLYLYSINE - GRAS 336

STRYKER NAVIGATION SYS KNEE MODULE - K010204

ACUMEN SURGICAL NAVIGATION SYS - K031337

STRYKER NAVIGATION SYS KNEE MODULE - K022579

HEALTHANYWHERE (HA) SYS - K091220

ADVANCED BIONICS LLC - CLARION CII BIONIC EAR,HIRESOULTION BIONIC EAR SYS 510K, PMA

SAFILO SPA, PADOVA ITALY; MARCOLIN SPA, LONGARONE,ITALY, LUXOTTICA SRL, AGORDO, BELLUNO, ITALY -OPTICAL FRAMES & SUNGLASSES DVC LISTING NUMBERS

ENZYME MODIFIED STEVIOL GLYCOSIDES - GRAS 337

L-THEANINE - GRAS 338

POLYGLUTAMIC ACID - GRAS 339

THEOBROMINE - GRAS 340

QUERCETIN - GRAS 341

OAT HULL FIBER - GRAS 342

WHEAT BRAN EXTRACT - GRAS 343

WAYNE MORSE

WAYNE MORSE

ADAM R BLOEDORN

WAYNE MORSE

WAYNE MORSE

WAYNE MORSE

LISA PETERSON

RASHA AWI

ADAM R BLOEDORN

ADAM R BLOEDORN

ADAM R BLOEDORN

ADAM R BLOEDORN

ADAM R BLOEDORN

ADAM R BLOEDORN

ADAM R BLOEDORN

MACPHERSON, JENNIFER L

OPERATIV

OPERATIV

Keller and Heckman LLP

OPERATIV

OPERATIV

OPERATIV

QA CONSULTING INC

HARDEN, ROBERT G

OPTICAL EXCHANGE







08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

2010-6078

2010-6079

2010-6080

2010-6081

2010-6082

2010-6083

2010-6084

2010-6085

2010-6086

2010-6087

2010-6088

2010-6089

2010-6090

2010-6091

2010-6092

2010-6093


CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/


CFSAN/OCD/EOS/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CFSAN/OCD/EOS/

CFSAN/OCD/EOS/

CFSAN/OCD/EOS/

CFSAN/OCD/EOS/

CFSAN/OCD/EOS/

CFSAN/OCD/EOS/

CFSAN/OCD/EOS/



24/65


q g g p

Total Records: 908

Page 24 of 65



BARLEY FIBER - GRAS 344

CARBOXYPEPTIDASE ENZYME - GRAS 345

FREEZE-DRIED FRUIT GAC POWDER - GRAS 346

CAFFEINE - GRAS 347

PINE TREE PHYTOSTEROL ESTERS - GRAS 335

GALACTO-OLIGOSACCHARIDES - GRAS 334

WUHAN GRAND PHARMACEUTICAL GROUP CO LTD,WUHAN, PR - 483S 5/11-14/09


ISRS 6700067, 6705157, 6758959, ETC



BRIMONIDINE TARTRATE, TIMOLOL MALEATE OPHTHALMICSOL ANDA 91-574 - RECS

FOI DAILY LOG 7/19-23/10. 7/26-30/10

LORAZEPAM, ATIVAN, HALDOL INJ, ETC - AERS

ZOMETA FORM 2253 ATTACHMENTS

JOHN FRATTI MTG - MINS 7/31/10

ADAM R BLOEDORN

ADAM R BLOEDORN

ADAM R BLOEDORN

ADAM R BLOEDORN

ADAM R BLOEDORN

ADAM R BLOEDORN

KLAS LINGREN


ROBERT Y LIN MD



KONI CROSSAN

FRAN KOCH

TERENCE J. SWEENEY

MATTHEW WHITAKER








APL PHARMA-SPECIALS

MERCK & CO., INC.

NEW YORK DOWNTOWNHOSPITAL

MERCK & CO., INC.

MERCK & CO., INC.

ISTA PHARMACEUTICALS

INFORMATION ACCESS

Doe J

TERENCE J SWEENEY LAW FIRM

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/10/2010

08/11/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

09/08/2010

2010-6094

2010-6095

2010-6096

2010-6097

2010-6098

2010-6099

2010-6100

2010-6101

2010-6102

2010-6103

2010-6104

2010-6105

2010-6106

2010-6107

2010-6108

2010-6109

CFSAN/OCD/EOS/

CFSAN/OCD/EOS/

CFSAN/OCD/EOS/

CFSAN/OCD/EOS/

CFSAN/OCD/EOS/

CFSAN/OCD/EOS/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/



25/65


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Total Records: 908

Page 25 of 65



ORTHO-MCNEIL - ORTHO EVRA AERS 2009-2010

WIRELESS MEDCARE LLC - VIVATRAK K101109

ABILIFY (ARIPIPRAZOLE) NDA 21-436 - APRVL TR, LBLG,RVWS, ETC

ALLERGAN INC - BOTOX (ONABOTULINUMTOXIN A) BL103000/5210, BL 103000/5209 RISK EVALUATION &MITIGATION STRATEGIES (REMS)

CLOSED FOIA REQUESTS 8/2-6/10

HUATEI BIOPHARM INC - 483 9/7-10/09

CLOSED FOIA REQUESTS 8/2-8/10

EMAILS BTWN MARY H PARKS & ROBERT I MISBIN &HYLTON JOFFE 11/27/07; EMAIL BTWN ROBERT MISBIN &MARY PARKS 11/27/07, ETC

TL10 TENSYMETER BLOOD PRESSURE MONITORING SYS -K020537; 5L100 TENSMETER BLOOD PRESSUREMONITORING SYS - K022783

HEALTHSTATTS - BPRO AMBULATORY BLOOD PRESSUREMONITORING SYS K060315

PDAC MTG - THOMAS P LAUGHREN MD MEMO 11/16/06(CERTIFIED)

PDAC & PEDS A/C - THOMAS P LAUGHREN MD MEMO8/16/04 (CERTIFIED)

MICHAEL TURIK, MD, INDIANAPOLIS, IN - EIRS 4/12/04 TO5/5/04 (CERTIFIED)

ATHENA GTX WVSM WIRELESS VITAL SIGNS MONITOR -K101674

GILEAD SCIENCES, SAN DIMAS, CA - 483S 1/10 TO 2/10,CORR, FORMS

ROBERT POWELL

GLEN FEYE

ANGELIA D SLAYTON

MARIE A DRAY

CECELIA FRENCH

CAROLYNE BOURGET

MASSIMO CALABRESI

JENNIFER INNAMORATO

JENNIFER INNAMORATO

MARILYNN WHITNEY

MARILYNN WHITNEY

MARILYNN WHITNEY

SERRAH NAMINI

THOMAS GRYTA

WESTLAW COURTEXPRESS

NBC NEWS

ACCURATE CONSULTANTS INC

INFORMATION ACCESS

International Regulatory AffairsGroup

CanReg, Inc.

BIODROGA INC

FOI SERVICES INC

TIME

FRANTZ MEDICALDEVELOPMENT

FRANTZ MEDICAL

DEVELOPMENT

COVINGTON & BURLING LLP



SOTERA WIRELESS

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

2010-6110

2010-6111

2010-6112

2010-6113

2010-6114

2010-6115

2010-6116

2010-6117

2010-6118

2010-6119

2010-6120

2010-6121

2010-6122

2010-6123

2010-6124

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDRH/OMO/DEMO/FOIB/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDRH/OMO/DEMO/FOIB/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

CDRH/OMO/DEMO/FOIB/

OM/OMP/DODM/

OM/OMP/DODM/


CDRH/OMO/DEMO/FOIB/




26/65


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Total Records: 908

Page 26 of 65



ALLERGAN - OPTICROM (SODIUM CROMOGLYCATE) EYEDROPS NDA 18-155 LBLG

BAXTER - TISSEEL (FIBRIN SEALANT) CLNCL STUDY RPTS

KEPPRA (LEVETIRACETAM) - AERS

CERTOLUZIMAB PERGOL (CP) - SUPPLEMENTAL APRVL5/09

MEDWATCH RPTS CODED AS MEDICATION ERRORS 7/1/10-8/1/10

ZOLADEX - AERS

ELI LILLY & CO INC - ROBERT TEMPLE MD APRVL LTR8/3/04 (CERTIFIED)

CYMBALTA (DULOXETINE) NDA 21-472 - APRVL RECS(CERTIFIED)

MICHAEL TURIK MD, INDIANA UNIV HOSPITAL - LTR 6/15/04(CERTIFIED)

NDA 21-427 MEMO 6/18/04 (CERTIFIED)




BOVINE THROMBIN/THROMBIN NOS/THROMBIN LOCAL SOL- VAERS 6814574, 7300201, 7167553, ETC


SRIRAM RAMANATHAN

NIR SHTAYER DVM

HELEN PENG

ROSE RELEVO

MICHAEL R COHEN RPH MS SCD

MARILYNN WHITNEY

MARILYNN WHITNEY

MARILYNN WHITNEY

MARILYNN WHITNEY




VAL LMOORE


DOW JONES NEWSWIRE

INNOPHARMA LLC

OMRIX BIOPHARMCEUTICALS

FAIRVIEW SOUTHDALEHOSPITAL

Oregon Health and ScienceUniversity

INSTITUTE FOR SAFE

MEDICATION PRACTICES

Doe J





MERCK & CO., INC.

MERCK & CO., INC.

MERCK & CO., INC.

ZYMOGENTICS INC

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

2010-6125

2010-6126

2010-6127

2010-6128

2010-6129

2010-6130

2010-6131

2010-6132

2010-6133

2010-6134

2010-6135

2010-6136

2010-6137

2010-6138

2010-6139

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/CBER/OCTMA/DDOM/ALFB/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/


OM/OSS/OPILS/DFI/



27/65


Total Records: 908

Page 27 of 65




DIETARY SUPP FACILITIES US OR FOREIGN - 483S

RECOMMENDATIONS OF THEPSYCHOPHARMACOLOGICAL DRUGS & PEDIATRIC A/C9/16/04 (CERTIFIED)

MEDICATED FEED INSP RPT - FORM 2481

LIST OF ALL FOREIGN & DOMESTIC DRUG INSP 5/10 TOPRESENT

SEPRACOR INC - LUNESTA (ESZOPICLONE TABS) AERS

SANOFI-AVENTIS US LLC - AMBIEN DCR (ZOLPICLEMTARTRATE TABS) AERS

BRISTOL-MYERS SQUIBB - DESYREL (TRAZOCLONE HCLTABS) AERS

BRISTOL MYERS SQUIBB - DESYREL (TRAZOCLONE HCLTABS) PI

DKT FDA- 2009-P-0123, FDA-2010-P-0196

JILLIAN MICHAELS - FAT BURNER PRODS CONTAINING

CITRUS AURANTIUM CMPLNTS

ELI LILLY AND CO MTG - CYMBALTA NDA 21-427 MINS11/17/06

EMAIL BTWN PAUL DAVID RPH & BARBARA ARNING, ELILILLY & CO REGARDING PROZAC/CYMBALTA/SYMBAXMEDICATION GUIDES 10/21/04 (CERTIFIED)

EMAIL BTWN PAUL DAVID RPH & BARBARA ARNING, ELILILLY & CO REGARDING PROZAC/CYMBALTA/SYMBYAXMEDICATION GUIDES 10/27/04 (CERTIFIED)

ELI LILLY & CO - RUSSELL KATZ MD LTR 1/26/05, LBLGGUIDE (CERTIFIED)


JOHN DOHERTY

MARILYNN WHITNEY

BOBBY SCHOCHET

DAVID P JORDAN

JOHN D. BEVAN 182723/42367

JOHN D. BEVAN 182723/42367

JOHN D. BEVAN 182723/42367

JOHN D. BEVAN 182723/42367

GARY LAZER

AASHISH Y DESAI

MARILYNN WHITNEY

MARILYNN WHITNEY

MARILYNN WHITNEY

MARILYNN WHITNEY

MERCK & CO., INC.

MERCK & CO., INC.

IOVATE HEALTH SCIENCESRESEARCH INC


OLSSON FRANK & WEEDA

THOMSON REUTERS

Central Utah Correctional Facility




BUC & BEARDSLEY

MOWER CARREON & DESAL LLP





08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

2010-6140

2010-6141

2010-6142

2010-6143

2010-6144

2010-6145

2010-6146

2010-6147

2010-6148

2010-6149

2010-6150

2010-6151

2010-6152

2010-6153

2010-6154

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

CVM/OCD/

ORA/ORM/

CDER/ORP/DIDP/


CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

OC/OM/OMP/DDM/

ORA/


CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/



28/65


Total Records: 908

Page 28 of 65



ELI LILLY & CO - NDA 21-427/S002 APRVL LTR 2/18/05, PI(CERTIFIED)

CYMBALTA NDA 21-733 - DIVISION DIRECTOR RVW 9/3/04,BASIS FOR APRVL ACTION (CERTIFIED)

2009-4220

2010-1480

2010-3777

2010-4190, 2010-4191

2010-4230

2010-4829

CMPLNT 115245

CMPLNT 114518

2010-5769 REQUEST LTR

THROMBIN - ISR 6653286

EMBEDA - ISRS 653513, 6542292, 6611887, ETC

ARROW INTERNATIONAL - A2 DUAL PORT SYS K955819

ARROW INTERNATIONAL - A2 PORT DUAL LUMEN SYSWITH DETACHER CATHETER K963684

COAST MEDICAL - K943270

COAST MEDICAL - K930930

MARILYNN WHITNEY

MARILYNN WHITNEY

FRAN DAUGHTRIDGE

FRAN DAUGHTRIDGE

DAVID A GREER

DAVID A GREER

TIM TRUITT

TIM TRUITT



MERCK & CO., INC.

MERCK & CO., INC.

MERCK & CO., INC.

MERCK & CO., INC.

MERCK & CO., INC.

MERCK & CO., INC.

AXEL, STANLEY

MILLER., DAVID

MERCK & CO., INC.

FRAN DAUGHTRIDGE PHARMD

FRAN DAUGHTRIDGE PHARMD

ANGIODYNAMICS INC

ANGIODYNAMICS INC

TRUER MEDICAL INC

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/11/2010

08/12/2010

08/12/2010

08/12/2010

08/12/2010

08/12/2010

08/12/2010

08/12/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/09/2010

09/10/2010

09/10/2010

09/10/2010

09/10/2010

09/10/2010

09/10/2010

2010-6155

2010-6156

2010-6157

2010-6158

2010-6159

2010-6160

2010-6161

2010-6162

2010-6163

2010-6164

2010-6165

2010-6166

2010-6167

2010-6168

2010-6169

2010-6170

2010-6171

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/


OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/



OM/OSS/OPILS/DFI/

OM/OSS/OPILS/DFI/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDER/ORP/DIDP/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/

CDRH/OMO/DEMO/FOIB/



29/65


Total Records: 908

Page 29 of 65



2009-8731

2009-8752

2009-9321

2009-9337

2009-9386

2009-9393

2009-9395

2009-9533

2007-5973

2009-8683

2009-8559

2009-8411

2009-8171

2009-7891

ALPO PURINA CAT FOOD - TEST RESULTS, RECS

TRUER MEDICAL INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

FOI SERVICES INC

Doe J

08/12/2010

08/12/2010

08/12/2010

08/12/2010

08/12/2010

08/12/2010

08/12/2010

08/12/2010

08/12/2010

08/12/2010

08/12/2010

08/12/2010

08/12/2010

08/12/2010

08/12/2010

09/10/2010

09/10/2010

09/10/2010

09/10/2010

09/10/2010

09/10/2010

09/10/2010

09/10/2010

09/10/2010

09/10/2010

09/10/2010

09/10/2010

09/10/2010

09/10/2010

09/10/2010

09/10/2010

2010-6172

2010-6173

2010-6174

2010-6175

2010-6176

2010-6177

2010-6178

2010-6179

2010-6180

2010-6181

2010-6182

2010-

Documents

Food and Drug Administration - FOIA Logs - August 2010