US Immigration and Customs Enforcement (ICE) - FOIA Logs - August 2010
Food and Drug Administration - FOIA Logs - August 2010
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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
FOI DAILY LOG 7/19-23/10
FOI DAILY LOG 7/19/23/10
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/
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8/8/2019 Food and Drug Administration - FOIA Logs - August 2010
2/65
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 2 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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
FOI DAILY LOG 7/19-23/10
2010-5276 - REQUEST LTR
2010-5318, 2010-5319 REQUEST LTR
2010-5390 - 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)
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/
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8/8/2019 Food and Drug Administration - FOIA Logs - August 2010
3/65
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 3 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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
KENDLE REGULATORY AFFAIRS
KENDLE REGULATORY AFFAIRS
THOMSON REUTERS
KENDLE REGULATORY AFFAIRS
KENDLE REGULATORY AFFAIRS
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/
-
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4/65
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 4 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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
KENDLE REGULATORY AFFAIRS
THOMSON REUTERS
KENDLE REGULATORY AFFAIRS
KENDLE REGULATORY AFFAIRS
WASHINGTON INFORMATIONSOURCE
WASHINGTON INFORMATIONSOURCE
WASHINGTON INFORMATIONSOURCE
WASHINGTON INFORMATIONSOURCE
WASHINGTON INFORMATIONSOURCE
WASHINGTON INFORMATIONSOURCE
WASHINGTON INFORMATIONSOURCE
WASHINGTON INFORMATIONSOURCE
WASHINGTON INFORMATIONSOURCE
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/
CBER/OCTMA/DDOM/ALFB/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
CBER/OCTMA/DDOM/ALFB/
CBER/OCTMA/DDOM/ALFB/
ORA/P-FO/SAN-DO/SFCB/
ORA/P-FO/SAN-DO/SFCB/
ORA/P-FO/SAN-DO/SFCB/
-
8/8/2019 Food and Drug Administration - FOIA Logs - August 2010
5/65
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 5 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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
WASHINGTON INFORMATIONSOURCE
INFORMATION ACCESS
ROBIN GUY CONSULTING LLC
BLOOMBERG NEWS
LACHMAN CONSULTANTSERVICES, INC.
Center for Regulatory Services, Inc.
ELI LILLY & CO
SCHRAMM WILLIAMS &ASSOCIATES INC
KENDLE REGULATORY AFFAIRS
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
ORA/P-FO/SAN-DO/SFCB/
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/
ORA/SE-FO/ATL-DO/ACB/
OM/OMP/DODM/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
CDRH/OMO/DEMO/FOIB/
OM/OSS/OPILS/DFI/
-
8/8/2019 Food and Drug Administration - FOIA Logs - August 2010
6/65
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 6 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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
JEREMY A GREENE MD PHD
JOCELYN KERSTEN
JOCELYN KERSTEN
JEREMY A GREENE MD PHD
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
HARVARD UNIV DEPT OF THEHISTORY OF SCIENCE
EKOS CORP
EKOS CORP
HARVARD UNIV DEPT OF THEHISTORY OF SCIENCE
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/
-
8/8/2019 Food and Drug Administration - FOIA Logs - August 2010
7/65Thursday 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 7 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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
GRAIG SUVANNAVEJH PHD
GRAIG SUVANNAVEJH PHD
BOBBY SCHOCHET
GRAIG SUVANNAVEJH PHD
GRAIG SUVANNAVEJH PHD
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/
-
8/8/2019 Food and Drug Administration - FOIA Logs - August 2010
8/65Thursday 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 8 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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
GRAIG SUVANNAVEJH PHD
GRAIG SUVANNAVEJH PHD
WALTER E. CHALKLEY
WALTER E. CHALKLEY
WALTER E. CHALKLEY
WALTER E. CHALKLEY
WALTER E. CHALKLEY
WALTER E. CHALKLEY
WALTER E. CHALKLEY
GRAIG SUVANNAVEJH, PhD
GRAIG SUVANNAVEJH, PhD
GRAIG SUVANNAVEJH, PhD
GRAIG SUVANNAVEJH, PhD
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/SE-FO/FLA-DO/FCB/
ORA/CE-FO/CHI-DO/CCB/
ORA/P-FO/SAN-DO/SFCB/
ORA/CE-FO/CIN-DO/CCB/
ORA/P-FO/SEA-DO/SCB/
ORA/SW-FO/KAN-DO/COMP/
ORA/CE-FO/MIN-DO/MCB/
ORA/NE-FO/NYK-DO/NYDCB/
ORA/SE-FO/SJN-DO/SJCB/
ORA/CE-FO/CIN-DO/CCB/
ORA/CE-FO/CIN-DO/CCB/
ORA/P-FO/LOS-DO/LACB/
ORA/P-FO/SAN-DO/SFCB/
ORA/SW-FO/DAL-DO/COMPLIANCE/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
ORA/CE-FO/CIN-DO/CCB/
ORA/P-FO/SEA-DO/SCB/
ORA/SE-FO/SJN-DO/SJCB/
-
8/8/2019 Food and Drug Administration - FOIA Logs - August 2010
9/65Thursday 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 9 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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
GRAIG SUVANNAVEJH, PhD
GRAIG SUVANNAVEJH, PhD
GRAIG SUVANNAVEJH, PhD
GRAIG SUVANNAVEJH, PhD
GRAIG SUVANNAVEJH, PhD
GRAIG SUVANNAVEJH, PhD
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/NYK-DO/NYDCB/
ORA/SE-FO/ATL-DO/ACB/
ORA/SW-FO/DEN-DO/COMP/
ORA/SW-FO/KAN-DO/COMP/
ORA/SE-FO/FLA-DO/FCB/
ORA/SE-FO/FLA-DO/FCB/
ORA/CE-FO/BLT-DO/CB/
ORA/NE-FO/NWE-DO/NWECB/
ORA/SE-FO/SJN-DO/SJCB/
ORA/SW-FO/DAL-DO/COMPLIANCE/
ORA/P-FO/SAN-DO/SFCB/
ORA/CE-FO/BLT-DO/CB/
ORA/CE-FO/CHI-DO/CCB/
ORA/CE-FO/MIN-DO/MCB/
ORA/CE-FO/PHI-DO/PCB/
ORA/NE-FO/NYK-DO/NYDCB/
ORA/P-FO/LOS-DO/LACB/
ORA/P-FO/SAN-DO/SFCB/
ORA/SE-FO/FLA-DO/FCB/
ORA/SW-FO/DAL-DO/COMPLIANCE/
ORA/SW-FO/DEN-DO/COMP/
ORA/SW-FO/KAN-DO/COMP/
ORA/CE-FO/BLT-DO/CB/
ORA/CE-FO/MIN-DO/MCB/
ORA/CE-FO/NJ-DO/NJCB/
ORA/CE-FO/PHI-DO/PCB/ORA/NE-FO/NYK-DO/NYDCB/
-
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10/65
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 10 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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
AEGIS REGULATORY INC
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
ORA/P-FO/LOS-DO/LACB/
ORA/SE-FO/FLA-DO/FCB/
ORA/SW-FO/KAN-DO/COMP/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
ORA/NE-FO/NYK-DO/NYDCB/
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/
ORA/SE-FO/ATL-DO/ACB/
ORA/CE-FO/BLT-DO/CB/
CDRH/OMO/DEMO/FOIB/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
CDRH/OMO/DEMO/FOIB/
CDRH/OMO/DEMO/FOIB/
OM/OSS/OPILS/DFI/
-
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11/65
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 11 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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
FOI DAILY LOG 7/26-30/10
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
JOAN STITT (UG2CD-16)
JOAN STITT (UG2CD-16)
JOAN STITT (UG2CD-16)
JOAN STITT (UG2CD-16)
JOAN STITT (UG2CD-16)
JOAN STITT (UG2CD-16)
VIRGINIA SMITH
SHERMAN L. MAH
PAMELA A. JACOBSON
REED TECHNOLOGY ANDINFORMATION SERVICES INC
REED SMITH LLP
FOI SERVICES INC
KENDLE REGULATORY AFFAIRS
KENDLE REGULATORY AFFAIRS
MERCK & CO., INC.
MERCK & CO., INC.
MERCK & CO., INC.
MERCK & CO., INC.
MERCK & CO., INC.
MERCK & CO., INC.
KENDLE REGULATORY AFFAIRS
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/
ORA/P-FO/SAN-DO/SFCB/
ORA/SE-FO/SJN-DO/SJCB/
CBER/OCTMA/DDOM/ALFB/
CBER/OCTMA/DDOM/ALFB/
CBER/OCTMA/DDOM/ALFB/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
ORA/P-FO/LOS-DO/LACB/
ORA/P-FO/LOS-DO/LACB/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
Di l FOI R L D f 08 0 20 0 08 3 20 0 R
-
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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 12 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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
UNIV OF MINNESOTA COLLEGEOF PHARMACY
UNIV OF MINNESOTA COLLEGEOF PHARMACY
UNIV OF MINNESOTA COLLEGEOF PHARMACY
UNIVERSITY OF MINNESOTA
UNIVERSITY OF MINNESOTA
UNIVERSITY OF MINNESOTA
UNIVERSITY OF MINNESOTA
UNIVERSITY OF MINNESOTA
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/
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
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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 13 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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/
CBER/OCTMA/DDOM/ALFB/
CFSAN/OCD/EOS/
CDRH/OMO/DEMO/FOIB/
ORA/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
ORA/ORM/
ORA/SE-FO/ATL-DO/ACB/
ORA/CE-FO/BLT-DO/CB/
ORA/CE-FO/CIN-DO/CCB/
ORA/CE-FO/PHI-DO/PCB/
ORA/CE-FO/CHI-DO/CCB/
ORA/SW-FO/DAL-DO/COMPLIANCE/
ORA/P-FO/SEA-DO/SCB/
ORA/SW-FO/DEN-DO/COMP/
ORA/CE-FO/DET-DO/DCB/
Di l FOI R t L D t f 08/01/2010 t 08/31/2010 R t
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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 14 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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
ORA/SE-FO/FLA-DO/FCB/
ORA/SE-FO/SJN-DO/SJCB/
CDRH/OMO/DEMO/FOIB/
ORA/P-FO/SAN-DO/SFCB/
CDRH/OMO/DEMO/FOIB/
ORA/CE-FO/MIN-DO/MCB/
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/
ORA/NE-FO/NWE-DO/NWECB/
ORA/CE-FO/CIN-DO/CCB/
ORA/NE-FO/NYK-DO/NYDCB/
ORA/CE-FO/CIN-DO/CCB/
ORA/SE-FO/NOL-DO/NOCB/
Disclosure FOI Request Log Date range from 08/01/2010 to 08/31/2010 Report
-
8/8/2019 Food and Drug Administration - FOIA Logs - August 2010
15/65
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 15 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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/
ORA/CE-FO/NJ-DO/NJCB/
ORA/NE-FO/NWE-DO/NWECB/
ORA/P-FO/LOS-DO/LACB/
ORA/SW-FO/KAN-DO/COMP/
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/
Disclosure FOI Request Log Date range from 08/01/2010 to 08/31/2010 Report
-
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16/65
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 16 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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/
ORA/CE-FO/CIN-DO/CCB/
ORA/SE-FO/ATL-DO/ACB/
ORA/SE-FO/NOL-DO/NOCB/
ORA/SW-FO/DAL-DO/COMPLIANCE/
ORA/SW-FO/DEN-DO/COMP/
ORA/SW-FO/KAN-DO/COMP/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
OC/OM/OEO/
ORA/SW-FO/DAL-DO/COMPLIANCE/
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/
Disclosure FOI Request Log Date range from 08/01/2010 to 08/31/2010 Report
-
8/8/2019 Food and Drug Administration - FOIA Logs - August 2010
17/65
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 17 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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/
ORA/SW-FO/DEN-DO/COMP/
ORA/SW-FO/DAL-DO/COMPLIANCE/
ORA/SW-FO/DEN-DO/COMP/
ORA/CE-FO/BLT-DO/CB/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
ORA/CE-FO/PHI-DO/PCB/
ORA/CE-FO/PHI-DO/PCB/
ORA/CE-FO/NJ-DO/NJCB/
ORA/P-FO/SAN-DO/SFCB/
ORA/NE-FO/NYK-DO/NYDCB/
ORA/NE-FO/NYK-DO/NYDCB/
OM/OMP/DODM/
CFSAN/OCD/EOS/
Disclosure FOI Request Log Date range from 08/01/2010 to 08/31/2010 Report
-
8/8/2019 Food and Drug Administration - FOIA Logs - August 2010
18/65
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 18 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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
HOGAN LOVELLS US LLP
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
HOGAN LOVELLS US LLP
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/
CBER/OCTMA/DDOM/ALFB/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
ORA/CE-FO/PHI-DO/PCB/
CFSAN/OCD/EOS/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
CFSAN/OCD/EOS/
ORA/CE-FO/CHI-DO/CCB/
OC/OSHC/OPD/
CFSAN/OCD/EOS/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
Disclosure FOI Request Log Date range from 08/01/2010 to 08/31/2010 Report
-
8/8/2019 Food and Drug Administration - FOIA Logs - August 2010
19/65
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 19 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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
KENDLE REGULATORY AFFAIRS
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
FULBRIGHT & JAWORSKI LLP
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/
ORA/CE-FO/PHI-DO/PCB/
CDRH/OMO/DEMO/FOIB/
ORA/SE-FO/FLA-DO/FCB/
ORA/SW-FO/DEN-DO/COMP/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
ORA/SE-FO/FLA-DO/FCB/
ORA/CE-FO/MIN-DO/MCB/
ORA/P-FO/LOS-DO/LACB/
CDER/ORP/DIDP/
CDER/ORP/DIDP/ORA/SE-FO/FLA-DO/FCB/
ORA/CE-FO/CHI-DO/CCB/
ORA/CE-FO/NJ-DO/NJCB/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
ORA/SW-FO/DEN-DO/COMP/
ORA/SE-FO/FLA-DO/FCB/
Disclosure FOI Request Log Date range from 08/01/2010 to 08/31/2010 Report
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20/65
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 20 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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
FOI DAILY LOG 7/26-30/10
CAPTEK SOFTGEL INTERNATIONAL INC, CERRITOS, CA -EIRS, 482, 483, ETC 2/10 TO PRESENT
FOI DAILY LOG 7/26-30/10
FOI DAILY LOG 7/26-30/10
FOI DAILY LOG 7/26-30/10
FOI DAILY LOG 7/26-30/10
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
FULBRIGHT & JAWORSKI LLP
THOMSON REUTERS
FULBRIGHT & JAWORSKI LLP
KENDLE REGULATORY AFFAIRS
FOI SERVICES INC
FULBRIGHT & JAWORSKI LLP
Center for Regulatory Services, Inc.
WASHINGTON INFORMATIONSOURCE
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/
ORA/P-FO/LOS-DO/LACB/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
OM/OSS/OPILS/DFI/
ORA/P-FO/LOS-DO/LACB/
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/
Disclosure FOI Request Log Date range from 08/01/2010 to 08/31/2010 Report
-
8/8/2019 Food and Drug Administration - FOIA Logs - August 2010
21/65
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 21 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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
JOAN STITT (UG2CD-16)
JOAN STITT (UG2CD-16)
JOAN STITT (UG2CD-16)
JOAN STITT (UG2CD-16)
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/
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/
Disclosure FOI Request Log Date range from 08/01/2010 to 08/31/2010 Report
-
8/8/2019 Food and Drug Administration - FOIA Logs - August 2010
22/65
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 22 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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/
ORA/P-FO/SEA-DO/SCB/
CDRH/OMO/DEMO/FOIB/
CDRH/OMO/DEMO/FOIB/
ORA/
ORA/CE-FO/MIN-DO/MCB/
ORA/NE-FO/NYK-DO/NYDCB/
ORA/P-FO/LOS-DO/LACB/
ORA/P-FO/SAN-DO/SFCB/ORA/P-FO/SEA-DO/SCB/
ORA/SE-FO/NOL-DO/NOCB/
ORA/SE-FO/SJN-DO/SJCB/
ORA/CE-FO/PHI-DO/PCB/
CDRH/OMO/DEMO/FOIB/
CDRH/OMO/DEMO/FOIB/
CFSAN/OCD/EOS/
Disclosure FOI Request Log Date range from 08/01/2010 to 08/31/2010 Report
-
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23/65
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 23 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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
Keller and Heckman LLP
Keller and Heckman LLP
Keller and Heckman LLP
Keller and Heckman LLP
Keller and Heckman LLP
Keller and Heckman LLP
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
ORA/CE-FO/DET-DO/DCB/
CDRH/OMO/DEMO/FOIB/
CDRH/OMO/DEMO/FOIB/
OM/OSS/OPILS/DFI/OM/OSS/OPILS/DFI/
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/
Disclosure FOI Request Log Date range from 08/01/2010 to 08/31/2010 Report
-
8/8/2019 Food and Drug Administration - FOIA Logs - August 2010
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Total Records: 908
Page 24 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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
FOI DAILY LOG 8/2-6/10
ISRS 6700067, 6705157, 6758959, ETC
2010-5470 - REQUEST LTR
2010-5620 - REQUEST LTR
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
JOAN STITT (UG2CD-16)
ROBERT Y LIN MD
JOAN STITT (UG2CD-16)
JOAN STITT (UG2CD-16)
KONI CROSSAN
FRAN KOCH
TERENCE J. SWEENEY
MATTHEW WHITAKER
Keller and Heckman LLP
Keller and Heckman LLP
Keller and Heckman LLP
Keller and Heckman LLP
Keller and Heckman LLP
Keller and Heckman LLP
Keller and Heckman LLP
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/
Disclosure FOI Request Log Date range from 08/01/2010 to 08/31/2010 Report
-
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Total Records: 908
Page 25 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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
COVINGTON & BURLING LLP
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/
ORA/CE-FO/DET-DO/DCB/
CDRH/OMO/DEMO/FOIB/
ORA/P-FO/LOS-DO/LACB/
Disclosure FOI Request Log Date range from 08/01/2010 to 08/31/2010 Report
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Total Records: 908
Page 26 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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)
2010-5722 - REQUEST LTR
2010-5687 - REQUEST LTR
2010-5734 - REQUEST LTR
BOVINE THROMBIN/THROMBIN NOS/THROMBIN LOCAL SOL- VAERS 6814574, 7300201, 7167553, ETC
2010-5747 - REQUEST LTR
SRIRAM RAMANATHAN
NIR SHTAYER DVM
HELEN PENG
ROSE RELEVO
MICHAEL R COHEN RPH MS SCD
MARILYNN WHITNEY
MARILYNN WHITNEY
MARILYNN WHITNEY
MARILYNN WHITNEY
JOAN STITT (UG2CD-16)
JOAN STITT (UG2CD-16)
JOAN STITT (UG2CD-16)
VAL LMOORE
JOAN STITT (UG2CD-16)
DOW JONES NEWSWIRE
INNOPHARMA LLC
OMRIX BIOPHARMCEUTICALS
FAIRVIEW SOUTHDALEHOSPITAL
Oregon Health and ScienceUniversity
INSTITUTE FOR SAFE
MEDICATION PRACTICES
Doe J
COVINGTON & BURLING LLP
COVINGTON & BURLING LLP
COVINGTON & BURLING LLP
COVINGTON & BURLING LLP
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/
CBER/OCTMA/DDOM/ALFB/
OM/OSS/OPILS/DFI/
Disclosure FOI Request Log Date range from 08/01/2010 to 08/31/2010 Report
-
8/8/2019 Food and Drug Administration - FOIA Logs - August 2010
27/65
Thursday September 9 2010 4:28 PM
Total Records: 908
Page 27 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
2010-5755 - REQUEST LTR
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)
JOAN STITT (UG2CD-16)
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
COVINGTON & BURLING LLP
OLSSON FRANK & WEEDA
THOMSON REUTERS
Central Utah Correctional Facility
Central Utah Correctional Facility
Central Utah Correctional Facility
Central Utah Correctional Facility
BUC & BEARDSLEY
MOWER CARREON & DESAL LLP
COVINGTON & BURLING LLP
COVINGTON & BURLING LLP
COVINGTON & BURLING LLP
COVINGTON & BURLING 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/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
OC/OM/OMP/DDM/
ORA/
ORA/SW-FO/DEN-DO/COMP/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
CDER/ORP/DIDP/
Disclosure FOI Request Log Date range from 08/01/2010 to 08/31/2010 Report
-
8/8/2019 Food and Drug Administration - FOIA Logs - August 2010
28/65
Thursday September 9 2010 4:28 PM
Total Records: 908
Page 28 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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
COVINGTON & BURLING LLP
COVINGTON & BURLING LLP
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/
ORA/CE-FO/BLT-DO/CB/
ORA/SE-FO/ATL-DO/ACB/
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/
Disclosure FOI Request Log Date range from 08/01/2010 to 08/31/2010 Report
-
8/8/2019 Food and Drug Administration - FOIA Logs - August 2010
29/65
Thursday September 9 2010 4:28 PM
Total Records: 908
Page 29 of 65
Control # Recd Date / Due Date
Action Office Signature/ Requester Subject
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-