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Food and Drug Administration - FOIA Logs - August 2010

Food and Drug Administration - FOIA Logs - August 2010

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Published by Jason Smathers
Recieved Thu, Sep 9, 2010 at 4:36 PM (EDT) as PDF attachment to email.
Recieved Thu, Sep 9, 2010 at 4:36 PM (EDT) as PDF attachment to email.

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Published by: Jason Smathers on Sep 09, 2010
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09/09/2010

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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 1 of 65
Control #Recd Date Due DateAction OfficeSignature/ RequesterSubjectFOI DAILY LOG 7/19-23/10FOI DAILY LOG 7/19-23/10FOI DAILY LOG 7/19-23/10FOI DAILY LOG 7/19/23/10FOI DAILY LOG 7/19-23/10FOI DAILY LOG 7/19-23/10BL HEALTHCARE - TCX-I-DV REMOTE CAREMANAGEMENT SYS K0933792007-12002010-4560NEPHROS, INC - DSU DUAL STAGE ULTRAFILTER K090885NIKKISO CO - DBB-05 HEMODIALYSIS DELIVERY SYSK061519DAVITA CLINICAL RESEARCH - DBB-05 HEMODIALYSISDELIVERY SYS K023509ROCKWELL MEDICAL TECHNOLOGIES INC - CITRAPUREK062399GAMBRO RENAL PRODUCTS - PRISMA SYS K010805GAMBRO RENAL PRODUCTS - PRISMA SYS R03 10AK062090GAMBRO - PRISMAFLEX SYS VERSION 3.20 K072093CanReg, Inc.WALTERS KLUWER LAW &BUSINESSCenter for Regulatory Services, Inc.WASHINGTON INFORMATIONSOURCEKENDLE REGULATORY AFFAIRSFOI SERVICES INCFOI SERVICES INCFOI SERVICES INCFOI SERVICES INCFOI SERVICES INCFOI SERVICES INCFOI SERVICES INCFOI SERVICES INCFOI SERVICES INCFOI SERVICES INC08/02/201008/02/201008/02/201008/02/201008/02/201008/02/201008/02/201008/02/201008/02/201008/02/201008/02/201008/02/201008/02/201008/02/201008/02/201008/02/201008/30/201008/30/201008/30/201008/30/201008/30/201008/30/201008/30/201008/30/201008/30/201008/30/201008/30/201008/30/201008/30/201008/30/201008/30/20102010-57812010-57822010-57832010-57842010-57852010-57862010-57872010-57882010-57892010-57902010-57912010-57922010-57932010-57942010-57952010-5796OM/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/ 
 
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 DateAction OfficeSignature/ RequesterSubjectB BRAUN MEDICAL - DIAPACT CRRT K973322B BRAUN MEDICAL - INTROCAN SAFETY IV CATHETERK020785GAMBRO RENAL PRODUCTS - PRISMASATE DIALYSISSOLUTIONS FOR CONTINUOUS RENAL REPLACEMENTTHERAPY K072908HEMAMETRICS - CRIT-LINE MONITOR III TQA K011741FOI DAILY LOG 7/19-23/102010-5276 - REQUEST LTR2010-5318, 2010-5319 REQUEST LTR2010-5390 - REQUEST LTRSUN - SUATRIPAN SUCCINATI QUALITY CONTROLPROGRAM FOR DRUGS MADE OUTSIDE OF USAGLENMARK - GABAPENTIN QUALITY CONTROL PROGRAMFOR DRUGS MADE OUTSIDE OF USAPARK DAVIS - LYRICA QUALITY CONTROL PROGRAM FORDRUGS MADE OUTSIDE USAPHOENIX EPIDURAL & SPINAL NEEDLES - K990519SOMAXON PHARMACEUTICALS INC - SILENOR (DOXEPINEHCL) NDA 22-036 RVWS, ADMINISTRATIVE RECSPQ CORP, UTICA, IL - EIRS 2/08, 4/26/10 TO 5/6/10DRUG LISTING RECS FOR OTC PRODUCTS - UPDATEDVERSIONJOAN STITT (UG2DC-16)LOAN STITT (UG2CD-16)JOAN STITT (UG2CD-16)JOAN STITT (UG2CD-16)SANJIV KUMARCOLLEEN GRACE DONOFRIOMARCIA D HOWARDFOI SERVICES INCFOI SERVICES INCFOI SERVICES INCFOI SERVICES INCFOI SERVICES INCMERCK & CO., INC.MERCK & CO., INC.MERCK & CO., INC.MERCK & CO., INC.BRODBECK, TOMBRODBECK, TOMBRODBECK, TOMMYCO MEDICALBLUMHARDT, CHRISTINEBABST CALLAND CLEMENTS ETALCONSUMER HEALTHINFORMATION CORPORATION08/02/201008/02/201008/02/201008/02/201008/02/201008/02/201008/02/201008/02/201008/02/201008/02/201008/02/201008/02/201008/02/201008/02/201008/02/201008/30/201008/30/201008/30/201008/30/201008/30/201008/30/201008/30/201008/30/201008/30/201008/30/201008/30/201008/30/201008/30/201008/30/201008/30/201008/30/20102010-57972010-57982010-57992010-58002010-58012010-58022010-58032010-58042010-58052010-58062010-58072010-58082010-58092010-58102010-5811CDRH/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/ 
 
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 DateAction OfficeSignature/ RequesterSubjectPUBLICATIONS HHS-ODPHP-2010-01, 00-4084, 01-3290,ETCDKTS FDA-1997-P-0537, FDA-1989-P-0008, FDA-1999-D-0061, ETC.BIOVAIL CORP - EIRS, 483S, WARNING LTRS ETC 2009-2010CEPHALON INC - EIRS, 483S, WARNING LTRS, ETC 2009-2010ENDO PHARMACEUTICALS - EIRS, 493S, WARNING LTRSETC 2009-2010PAUL W FRANCK, FRANCK'S LAB INC, FRANCK'SPHARMACY INC, ETC - INVESTIGATION CORR, RPTS,WARNING LTR, ETC 4/19/09BURZYNSKI RESEARCH INSTITUTE (BRI), HOUSTON, TX -EIRS, 483S, & CO RESP12/3-10/08TAPENTADOL - ISRS 6439998, 6301260, 6314426, ETCK073515HI-TECH PHARMACAL, AMITYVILLE, NY - EIRS, 483S, CORESP 10/21/03 TO 12/09K061041k953076CICELY PARSEGHIANGRAIG SUVANNAVEJHGRAIG SUVANNAVEJHGRAIG SUVANNAVEJHTHOMAS WADE YOUNGELIZABETH WOECKNERVIRGINIA SMITHVIRGINIA SMITHWALTER E CHALKLEYVIRGINIA SMITHVIRGINIA SMITHWILLIAMS FDC# E20560, LESTERLFOLEY HOAG LLPJEFFERIES & COJEFFERIES & COJEFFERIES & CODEMPSEY & ACCOCIATES PACITIZENS FOR RESPONSIBLECARE & RESEARCHKENDLE REGULATORY AFFAIRSKENDLE REGULATORY AFFAIRSTHOMSON REUTERSKENDLE REGULATORY AFFAIRSKENDLE REGULATORY AFFAIRS08/02/201008/02/201008/03/201008/03/201008/03/201008/03/201008/03/201008/03/201008/03/201008/03/201008/03/201008/03/201008/30/201008/30/201008/31/201008/31/201008/31/201008/31/201008/31/201008/31/201008/31/201008/31/201008/31/201008/31/20102010-58122010-58132010-58142010-58152010-58162010-58172010-58182010-58192010-58202010-58212010-58222010-5823OM/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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