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Rachael A. Callcut, M.D., M.S.P.H. - Form 483, 2018-12-13
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Rachael A. Callcut, M.D., M.S.P.H. [San Francisco / United States of America]
Theken Companies LLC - Form 483, 2018-12-13
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Theken Companies LLC [Akron / United States of America]
Ultrapure & Industrial Services LLC - Form 483R, 2018-12-27
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483 Response
Site Name: Ultrapure & Industrial Services LLC [Dallas / United States of America]
DJ Orthopedics de Mexico S.A. de C.V. - Form 483, 2018-12-13
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: DJ Orthopedics de Mexico S.A. de C.V. [Tijuana / Mexico]
Hamamatsu / Queens PET Imaging Center, LLC - Form 483, 2018-12-13
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Hamamatsu / Queens PET Imaging Center, LLC [Honolulu / United States of America]
Asap Endoscopic Products GmbH - Form 483, 2018-12-13
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Asap Endoscopic Products GmbH [Umkirch / Germany]
Conod Medical Co., Limited - EIR, 2018-12-31
$1190 - Available for instant download
Issued On: December, 2018
Inspection Type: EIR
Albert Einstein College of Medicine IRB - Form 483, 2018-12-13
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Albert Einstein College of Medicine IRB [Bronx / United States of America]
Kitron AB - Form 483, 2018-12-13
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Kitron AB [Jönköping / Sweden]
Grifols Therapeutics LLC - EIR, 2019-02-21
$1190 - Available for instant download
Issued On: December, 2018
Inspection Type: EIR
Site Name: Grifols Therapeutics LLC [Clayton / United States of America]
Ultrapure & Industrial Services LLC - Form 483, 2018-12-13
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Ultrapure & Industrial Services LLC [Dallas / United States of America]
Advance Pharmaceutical, Inc. - Form 483, 2018-12-13
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Advance Pharmaceutical, Inc. [Holtsville / United States of America]
HealthDent'l LLC - Form 483, 2018-12-13
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: HealthDent'l LLC [Plainfield / United States of America]
BioLife Plasma Services, L.P. - Form 483, 2018-12-13
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: BioLife Plasma Services, L.P. [Onalaska / United States of America]
Grifols Therapeutics LLC - Form 483, 2018-12-13
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Grifols Therapeutics LLC [Clayton / United States of America]
Steiner Biotechnology LLC - Form 483, 2018-12-13
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Steiner Biotechnology LLC [Henderson / United States of America]
Wellman Advanced Materials, LLC - Form 483, 2018-12-13
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Wellman Advanced Materials, LLC [Johnsonville / United States of America]
Sunshine Mills, Inc. - Form 483, 2018-12-13
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Sunshine Mills, Inc. [Tupelo / United States of America]
Vida International, Inc. - Form 483, 2018-12-13
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Vida International, Inc. [Zhong Shan Qu / Taiwan]
NPA - Nucleo de Pesquisas Aplicadas Ltda. - Form 483, 2018-12-13
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: NPA - Nucleo de Pesquisas Aplicadas Ltda. [Jaboticabal / Brazil]
TELEMED - Form 483, 2018-12-13
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: TELEMED [Vilnius / Lithuania]
Kerry, Inc. - EIR, 2018-12-12
$1190 - Available for instant download
Issued On: December, 2018
Inspection Type: EIR
Swati Spentose Private Limited - Form 483, 2018-12-12
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
SmartGuard Rx, Inc. - Form 483, 2018-12-12
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: SmartGuard Rx, Inc. [Layton / United States of America]
SIDDHA FLOWER ESSENCES - Form 483, 2018-12-12
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: SIDDHA FLOWER ESSENCES [Oxnard / United States of America]
Atos Medical Inc - Form 483, 2018-12-12
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Atos Medical Inc [New Berlin / United States of America]
Kyowa Kirin Co., Ltd. - Form 483, 2018-12-11
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Med-Tech Resource LLC - Form 483, 2018-12-11
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Med-Tech Resource LLC [Eugene / United States of America]
Ingenus Pharmaceuticals GmbH - Form 483, 2018-12-11
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Ingenus Pharmaceuticals GmbH [Lugano / Switzerland]
Kama Sutra - Form 483, 2018-12-11
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Kama Sutra [Newbury Park / United States of America]
Brenntag Southwest, Inc - Form 483, 2018-12-11
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Brenntag Southwest, Inc [Longview / United States of America]
Organic India USA, LLC - Form 483, 2018-12-11
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Organic India USA, LLC [Boulder / United States of America]
SEAWAY PHARMA - Form 483, 2018-12-10
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: SEAWAY PHARMA [Massena / United States of America]
DoubleDay Acquisitions dba CSAFE Global - Form 483, 2018-12-10
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: DoubleDay Acquisitions dba CSAFE Global [Monroe / United States of America]
Integron Inc. - Form 483, 2018-12-10
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Integron Inc. [Rochester / United States of America]
Pharmacia & Upjohn Company LLC - Form 483, 2018-12-10
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Pharmacia & Upjohn Company LLC [Portage / United States of America]
SEAWAY PHARMA - EIR, 2018-12-10
$1190 - Available for instant download
Issued On: December, 2018
Inspection Type: EIR
Site Name: SEAWAY PHARMA [Massena / United States of America]
Phi Wiegn, M.D. - Form 483, 2018-12-10
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Phi Wiegn, M.D. [Dallas / United States of America]
SmartScience Laboratories, Inc. - Form 483, 2018-12-10
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: SmartScience Laboratories, Inc. [Tampa / United States of America]
Tianish Laboratories Private Limited - Form 483, 2018-12-10
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Tianish Laboratories Private Limited [Pusapatirega / India]
Cunningpac CC - Form 483, 2018-12-07
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Cunningpac CC [The Msunduzi / South Africa]
ZHEJIANG LEPU PHARMACEUTICAL CO., LTD. - Form 483, 2018-12-07
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: ZHEJIANG LEPU PHARMACEUTICAL CO., LTD. [Jiaojiang Shi / China]
American Airlines - Form 483, 2018-12-07
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: American Airlines [Greensboro / United States of America]
Lyophilization Services Of New England, Inc. (LSNE) - EIR, 2018-12-07
$1190 - Available for instant download
Issued On: December, 2018
Inspection Type: EIR
Site Name: Lyophilization Services Of New England, Inc. (LSNE) [Bedford / United States of America]
Lyophilization Services Of New England, Inc. (LSNE) - Form 483, 2018-12-07
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Lyophilization Services Of New England, Inc. (LSNE) [Bedford / United States of America]
Haupt Pharma Wuelfing GmbH - EIR, 2018-12-07
$1190 - Available for instant download
Issued On: December, 2018
Inspection Type: EIR
Site Name: Haupt Pharma Wuelfing GmbH [Gronau (Leine) / Germany]
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. - Form 483, 2018-12-07
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. [Dongyang / China]
ROTOP Pharmaka GmbH - Form 483, 2018-12-09
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: ROTOP Pharmaka GmbH [Dresden / Germany]
Changzhou BOHIV Pharmaceutical Technology Co., Ltd - Form 483, 2018-12-07
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Changzhou BOHIV Pharmaceutical Technology Co., Ltd [Xinbei / China]
Recipharm Pharmaservices Pvt. Ltd. - Form 483, 2018-12-07
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Recipharm Pharmaservices Pvt. Ltd. [Nelamangala / India]
Lyophilization Services Of New England, Inc. (LSNE) - Form 483R, 2018-12-30
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483 Response
Site Name: Lyophilization Services Of New England, Inc. (LSNE) [Bedford / United States of America]
Adrian Wlodarczak - Form 483, 2018-12-07
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Adrian Wlodarczak [Lubin / Poland]
Becton Dickinson, S.A. - Form 483, 2018-12-07
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Becton Dickinson, S.A. [Fraga / Spain]
Enantiotech Corporation Limited - Form 483, 2018-12-07
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Enantiotech Corporation Limited [Xiangshan / China]
Geneva Woods Pharmacy - Form 483, 2018-12-07
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Geneva Woods Pharmacy [Anchorage / United States of America]
Laboratorios Jaloma, S.A. de C.V. - Form 483, 2018-12-07
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Laboratorios Jaloma, S.A. de C.V. [México / Mexico]
Nutravail LLC - Form 483, 2018-12-07
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Nutravail LLC [Chantilly / United States of America]
Sun Pharmaceutical Industries Limited - EIR, 2018-12-06
$1190 - Available for instant download
Issued On: December, 2018
Inspection Type: EIR
Site Name: Sun Pharmaceutical Industries Limited [Halol / India]
LEXAMED - EIR, 2018-12-06
$1190 - Available for instant download
Issued On: December, 2018
Inspection Type: EIR
Site Name: LEXAMED [Toledo / United States of America]
Tcoag Deutschland GmbH - Form 483, 2018-12-06
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Tcoag Deutschland GmbH [Lemgo / Germany]
Linde Gas & Equipment Inc. - Form 483, 2018-12-06
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Linde Gas & Equipment Inc. [Twinsburg / United States of America]
Oakdale Precision Inc - Form 483, 2018-12-06
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Oakdale Precision Inc [Saint Paul / United States of America]
J & M Urinary Catheters, LLC - Form 483, 2018-12-06
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: J & M Urinary Catheters, LLC [Las Vegas / United States of America]
AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care - Form 483R, 2018-12-06
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483 Response
Global Packaging Systems - EIR, 2018-12-06
$1190 - Available for instant download
Issued On: December, 2018
Inspection Type: EIR
Site Name: Global Packaging Systems [Fort Worth / United States of America]
Intelligent Retinal Imaging Systems Inc. - Form 483, 2018-12-06
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Intelligent Retinal Imaging Systems Inc. [Pensacola / United States of America]
EPIEN Medical, Inc. - Form 483, 2018-12-06
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: EPIEN Medical, Inc. [Saint Paul / United States of America]
LEXAMED - Form 483, 2018-12-06
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: LEXAMED [Toledo / United States of America]
Tri State De Mexico SA De R.L. C.V. - Form 483, 2018-12-06
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Tri State De Mexico SA De R.L. C.V. [Mexicali / Mexico]
Boehringer Ingelheim Pharmaceuticals, Inc. - Form 483, 2018-12-06
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Boehringer Ingelheim Pharmaceuticals, Inc. [Ridgefield / United States of America]
AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care - Form 483, 2018-12-06
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Chirogate International Inc. - EIR, 2018-12-06
$1190 - Available for instant download
Issued On: December, 2018
Inspection Type: EIR
Site Name: Chirogate International Inc. [Yangmei District / Taiwan]
AMCOL Health & Beauty Solutions, Inc DBA AMCOL Household and Personal Care - EIR, 2018-12-06
$1190 - Available for instant download
Issued On: December, 2018
Inspection Type: EIR
Neal S. Kleiman, M.D. - Form 483, 2018-12-06
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Neal S. Kleiman, M.D. [Houston / United States of America]
Bell Brands, Inc. - EIR, 2018-12-06
$1190 - Available for instant download
Issued On: December, 2018
Inspection Type: EIR
Site Name: Bell Brands, Inc. [Sanborn / United States of America]
International Vitamin - EIR, 2018-12-06
$1190 - Available for instant download
Issued On: December, 2018
Inspection Type: EIR
Site Name: International Vitamin [Greenville / United States of America]
NEWCLIP TECHNICS, SAS - Form 483, 2018-12-06
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
INGENUE CARE - Form 483, 2018-12-06
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: INGENUE CARE [Norwalk / United States of America]
ANDERSONBRECON INC. - EIR, 2018-12-05
$1190 - Available for instant download
Issued On: December, 2018
Inspection Type: EIR
Site Name: ANDERSONBRECON INC. [Rockford / United States of America]
Philips North America, LLC - Form 483, 2018-12-04
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Philips North America, LLC [Andover / United States of America]
LUPIN LIMITED - Form 483, 2018-12-04
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: LUPIN LIMITED [Mandideep / India]
Aspen SA Sterile Operations (Pty) Ltd - Form 483, 2018-12-04
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Aspen SA Sterile Operations (Pty) Ltd [Nelson Mandela Bay / South Africa]
Mpi Medical Products, Inc. - Form 483, 2018-12-04
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Mpi Medical Products, Inc. [Palm Bay / United States of America]
Antares Pharma, Inc. - Form 483, 2018-12-04
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Antares Pharma, Inc. [Hopkins / United States of America]
Fresenius Kabi Compounding, LLC - Form 483, 2018-12-04
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Fresenius Kabi Compounding, LLC [Canton / United States of America]
National Genetics Institute - EIR, 2018-12-04
$1190 - Available for instant download
Issued On: December, 2018
Inspection Type: EIR
Site Name: National Genetics Institute [Los Angeles / United States of America]
Nutricia NV - EIR, 2018-12-04
$1190 - Available for instant download
Issued On: December, 2018
Inspection Type: EIR
Site Name: Nutricia NV [Zoetermeer / Netherlands]
Guittard Chocolate Company - Form 483, 2018-12-04
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Guittard Chocolate Company [Burlingame / United States of America]
LGM PHARMA, LLC - Form 483, 2018-12-04
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: LGM PHARMA, LLC [Erlanger / United States of America]
Taurus Engineering and Manufacturing, Inc. - Form 483, 2018-12-04
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Taurus Engineering and Manufacturing, Inc. [Saint Paul / United States of America]
National Genetics Institute - Form 483R, 2018-12-21
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483 Response
Site Name: National Genetics Institute [Los Angeles / United States of America]
Novartis Pharma Stein AG - Form 483, 2018-12-04
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Fresenius Medical Care de Mexico, S.A. de C.V. - Form 483, 2018-12-04
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Fresenius Medical Care de Mexico, S.A. de C.V. [Glorias Del Colli / Mexico]
Nexgen Pharma, Inc. - EIR, 2019-02-05
$1190 - Available for instant download
Issued On: December, 2018
Inspection Type: EIR
Site Name: Nexgen Pharma, Inc. [Rosenberg / United States of America]
Cayman Chemical Company, Inc. - Form 483, 2018-12-03
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Cayman Chemical Company, Inc. [Ann Arbor / United States of America]
Philips North America LLC - Form 483, 2018-12-03
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Philips North America LLC [Bothell / United States of America]
SOFIE Co. dba SOFIE - EIR, 2018-12-03
$1190 - Available for instant download
Issued On: December, 2018
Inspection Type: EIR
Site Name: SOFIE Co. dba SOFIE [Sterling / United States of America]
Sysco Guest Supply, LLC - Form 483, 2018-12-03
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Sysco Guest Supply, LLC [Sayreville / United States of America]
Cayman Chemical Company, Inc. - Form 483R, 2018-12-10
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483 Response
Site Name: Cayman Chemical Company, Inc. [Ann Arbor / United States of America]
Merrill D. Benson, M.D. - Form 483, 2018-12-03
$289 - Available for instant download
Issued On: December, 2018
Inspection Type: FDA 483
Site Name: Merrill D. Benson, M.D. [Indianapolis / United States of America]