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MANDELAY KFT - Form 483, 2019-10-17
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: MANDELAY KFT [Tököl / Hungary]
Sekisui Medical Co., Ltd - Form 483, 2019-10-17
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Sekisui Medical Co., Ltd [Koyodai / Japan]
John J. Wroblewski, M.D. - Form 483, 2019-10-17
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: John J. Wroblewski, M.D. [Hagerstown / United States of America]
Kennedy, Philip R. - Form 483, 2019-10-16
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Kennedy, Philip R. [Duluth / United States of America]
Frederick J. Snoy, M.D. - Form 483, 2019-10-11
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Frederick J. Snoy, M.D. [Albuquerque / United States of America]
FUJIFILM Diosynth Biotechnologies Denmark ApS - Form 483, 2019-10-11
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: FUJIFILM Diosynth Biotechnologies Denmark ApS [Hillerød / Denmark]
KarePak LLC - Form 483, 2019-10-09
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Tusker Medical, Inc. - EIR, 2019-10-08
$1190 - Available for instant download
Issued On: October, 2019
Inspection Type: EIR
Site Name: Tusker Medical, Inc. [Menlo Park / United States of America]
Tusker Medical, Inc. - Form 483, 2019-10-08
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Tusker Medical, Inc. [Menlo Park / United States of America]
Alan E. Kimura, M.D. - Form 483, 2019-10-04
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Alan E. Kimura, M.D. [Golden / United States of America]
Kyowa Kirin Co., Ltd. - Form 483, 2019-10-04
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Mehrdad Kevin Ariani, MD - Form 483, 2019-10-04
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Mehrdad Kevin Ariani, MD [Northridge / United States of America]
Future Pak Ltd. - Form 483, 2019-10-02
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Future Pak Ltd. [Wixom / United States of America]
Skyline Medical, Inc. - Form 483, 2019-10-01
$289 - Available for instant download
Issued On: October, 2019
Inspection Type: FDA 483
Site Name: Skyline Medical, Inc. [Saint Paul / United States of America]
Pink, Inc. dba Hearten - Form 483, 2019-09-30
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Pink, Inc. dba Hearten [Henrico / United States of America]
Oncotec Pharma Produktion GmbH - EIR, 2019-10-24
$1190 - Available for instant download
Issued On: September, 2019
Inspection Type: EIR
Site Name: Oncotec Pharma Produktion GmbH [Dessau-Rosslau / Germany]
Snyder Mark Drugs Roselle, Inc. d.b.a. Mark Drugs Pharmacy - Form 483, 2019-09-27
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Snyder Mark Drugs Roselle, Inc. d.b.a. Mark Drugs Pharmacy [Roselle / United States of America]
Nature's Natural Products, INC. DBA Nature's Skin and Body Food - Form 483, 2019-09-27
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Dukal Corporation - Form 483, 2019-09-27
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Dukal Corporation [Ronkonkoma / United States of America]
Dukal Corporation - EIR, 2019-10-11
$1190 - Available for instant download
Issued On: September, 2019
Inspection Type: EIR
Site Name: Dukal Corporation [Ronkonkoma / United States of America]
Roger S. Keresztes, M.D. - Form 483, 2019-09-27
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Roger S. Keresztes, M.D. [Stony Brook / United States of America]
Glenmark Pharmaceuticals Limited - Form 483, 2019-09-27
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Glenmark Pharmaceuticals Limited [Bardez / India]
Tektone Sound & Signal Mfg.Inc. - EIR, 2019-10-22
$1190 - Available for instant download
Issued On: September, 2019
Inspection Type: EIR
Site Name: Tektone Sound & Signal Mfg.Inc. [Franklin / United States of America]
Elizabeth Plimack, MD, MS - Form 483, 2019-09-26
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Elizabeth Plimack, MD, MS [Philadelphia / United States of America]
Sergey Likhachev, M.D., Ph.D. - EIR, 2019-09-26
$1190 - Available for instant download
Issued On: September, 2019
Inspection Type: EIR
Site Name: Sergey Likhachev, M.D., Ph.D. [Belarus’ / Belarus]
Tektone Sound & Signal Mfg.Inc. - Form 483, 2019-09-26
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Tektone Sound & Signal Mfg.Inc. [Franklin / United States of America]
Florida Smoked Fish, LLC - Form 483, 2019-09-25
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Florida Smoked Fish, LLC [Miami / United States of America]
Paragon BioTeck, Inc. - EIR, 2019-09-25
$1190 - Available for instant download
Issued On: September, 2019
Inspection Type: EIR
Site Name: Paragon BioTeck, Inc. [Portland / United States of America]
Takeda - Form 483, 2019-09-25
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Daniel P. Petrylak, M.D. - EIR, 2019-09-20
$1190 - Available for instant download
Issued On: September, 2019
Inspection Type: EIR
Site Name: Daniel P. Petrylak, M.D. [New Haven / United States of America]
Merck Sharp & Dohme LLC - Form 483, 2019-09-20
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Merck Sharp & Dohme LLC [Lansdale / United States of America]
Merck Sharp & Dohme LLC - EIR, 2019-09-20
$1190 - Available for instant download
Issued On: September, 2019
Inspection Type: EIR
Site Name: Merck Sharp & Dohme LLC [Lansdale / United States of America]
Merck Sharp & Dohme LLC - Form 483R, 2019-10-07
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483 Response
Site Name: Merck Sharp & Dohme LLC [Lansdale / United States of America]
Boehringer Ingelheim Pharma GmbH and Co. KG - Form 483, 2019-09-19
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Boehringer Ingelheim Pharma GmbH and Co. KG [Biberach An Der Riss / Germany]
Anthony J. Windebank, M.D., Clinical Investigator - Form 483, 2019-09-19
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Anthony J. Windebank, M.D., Clinical Investigator [Rochester / United States of America]
DSM Nutritional Products AG Zweigniederlassung Werk Sisseln - EIR, 2024-01-18
$1190 - Available for instant download
Issued On: September, 2019
Inspection Type: EIR
Site Name: DSM Nutritional Products AG Zweigniederlassung Werk Sisseln [Sisseln / Switzerland]
Hangzhou Linkeweier Daily Chemicals Co., Ltd. - Form 483, 2019-09-17
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Hangzhou Linkeweier Daily Chemicals Co., Ltd. [Xiaoshan / China]
Glaxo Operations UK Ltd - Form 483, 2019-09-17
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Glaxo Operations UK Ltd [County Durham / United Kingdom of Great Britain and Northern Ireland]
Bayer Weimar GmbH und Co. KG - Form 483, 2019-09-13
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Korvis, LLC - Form 483, 2019-09-13
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Korvis, LLC [Corvallis / United States of America]
Ruspak Corporation - Form 483, 2019-09-13
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Ruspak Corporation [Manhattan / United States of America]
Kreitchman PET Center - Form 483, 2019-09-13
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Kreitchman PET Center [New York / United States of America]
Duerr Optronik Gmbh & Co. KG - Form 483, 2019-09-12
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Duerr Optronik Gmbh & Co. KG [Gechingen / Germany]
GlaxoSmithKline - EIR, 2019-09-12
$1190 - Available for instant download
Issued On: September, 2019
Inspection Type: EIR
Site Name: GlaxoSmithKline [Durham / United States of America]
Kerry, Inc. - Form 483, 2019-09-12
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Kerry, Inc. [Fredericksburg / United States of America]
Knowles Surgery Center, LLC - Form 483, 2019-09-11
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Knowles Surgery Center, LLC [Los Gatos / United States of America]
Hikma Pharmaceuticals USA Inc. - Form 483, 2019-09-10
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Hikma Pharmaceuticals USA Inc. [Cherry Hill / United States of America]
Otsuka Pharmaceutical Co Ltd - Form 483, 2019-09-10
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Otsuka Pharmaceutical Co Ltd [Kawauchicho / Japan]
Rockford Specialties - Form 483, 2019-09-10
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Rockford Specialties [Loves Park / United States of America]
Glaxo Operations UK Ltd - Form 483, 2019-09-06
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Glaxo Operations UK Ltd [East Hertfordshire / United Kingdom of Great Britain and Northern Ireland]
Merck Sharp & Dohme LLC - Form 483, 2019-09-06
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Merck Sharp & Dohme LLC [Rahway / United States of America]
Merck Sharp & Dohme LLC - Form 483R, 2019-09-24
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483 Response
Site Name: Merck Sharp & Dohme LLC [Rahway / United States of America]
Merck Sharp & Dohme LLC - EIR, 2019-09-06
$1190 - Available for instant download
Issued On: September, 2019
Inspection Type: EIR
Site Name: Merck Sharp & Dohme LLC [Rahway / United States of America]
Sidmak Laboratories India Pvt.Ltd. - Form 483, 2019-09-06
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Sidmak Laboratories India Pvt.Ltd. [Vikasnagar / India]
Choksi Laboratories Limited - Form 483, 2019-09-06
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Choksi Laboratories Limited [Indore / India]
Ningbo Luke Medical Devices Co., Ltd. - Form 483, 2019-09-05
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Ningbo Luke Medical Devices Co., Ltd. [Yangming / China]
Chongqing Kanghua Ruiming S&T Co., Ltd. - Form 483, 2019-09-05
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Chongqing Kanghua Ruiming S&T Co., Ltd. [Beibei / China]
Sukit Christopher Malaisrie, M.D. - Form 483, 2019-09-04
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Sukit Christopher Malaisrie, M.D. [Chicago / United States of America]
Fresenius Kabi Norge As - Form 483, 2019-09-03
$289 - Available for instant download
Issued On: September, 2019
Inspection Type: FDA 483
Site Name: Fresenius Kabi Norge As [Halden / Norway]
Kenneth Choi, M.D. - Form 483, 2019-08-30
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: Kenneth Choi, M.D. [Merrillville / United States of America]
Lafayette Work Center, Inc. - Form 483, 2019-08-29
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: Lafayette Work Center, Inc. [Saint Louis / United States of America]
Kerry Inc. - EIR, 2019-08-26
$1190 - Available for instant download
Issued On: August, 2019
Inspection Type: EIR
Site Name: Kerry Inc. [Rothschild / United States of America]
Ian E. Krop, M.D. - Form 483, 2019-08-26
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: Ian E. Krop, M.D. [Boston / United States of America]
West Duluth Distribution Company dba CHK Nutrition - EIR, 2019-08-23
$1190 - Available for instant download
Issued On: August, 2019
Inspection Type: EIR
Site Name: West Duluth Distribution Company dba CHK Nutrition [Cotton / United States of America]
BLV Licht- und Vakuumtechnik GmbH - Form 483, 2019-08-23
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: BLV Licht- und Vakuumtechnik GmbH [Steinhöring / Germany]
West Duluth Distribution Company dba CHK Nutrition - Form 483, 2019-08-23
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: West Duluth Distribution Company dba CHK Nutrition [Cotton / United States of America]
Eckert & Ziegler Radiopharma GmbH - Form 483, 2019-08-23
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: Eckert & Ziegler Radiopharma GmbH [Berlin / Germany]
S&B Pharma LLC DBA Alkem Laboratories - Form 483, 2019-08-22
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: S&B Pharma LLC DBA Alkem Laboratories [Fenton / United States of America]
Renaissance Lakewood LLC - Form 483, 2019-08-22
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: Renaissance Lakewood LLC [Lakewood / United States of America]
Waldemar Link GmbH & Co. KG (Mfg Site) - Form 483, 2019-08-22
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: Waldemar Link GmbH & Co. KG (Mfg Site) [Norderstedt / Germany]
LifeLink Foundation, Inc. - Form 483, 2019-08-21
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: LifeLink Foundation, Inc. [Orlando / United States of America]
CCRM New York - Form 483, 2019-08-21
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: CCRM New York [New York / United States of America]
KITE PHARMA, INC. - Form 483, 2019-08-20
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: KITE PHARMA, INC. [El Segundo / United States of America]
KITE PHARMA, INC. - EIR, 2019-08-20
$1190 - Available for instant download
Issued On: August, 2019
Inspection Type: EIR
Site Name: KITE PHARMA, INC. [El Segundo / United States of America]
New York Blood Center Inc - EIR, 2019-08-19
$1190 - Available for instant download
Issued On: August, 2019
Inspection Type: EIR
Site Name: New York Blood Center Inc [New York / United States of America]
Katja Sockel - EIR, 2019-08-16
$1190 - Available for instant download
Issued On: August, 2019
Inspection Type: EIR
Site Name: Katja Sockel [Dresden / Germany]
Nordmark Pharma GmbH - Form 483, 2019-08-16
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: Nordmark Pharma GmbH [Uetersen / Germany]
Kelyniam Global, Inc. - Form 483, 2019-08-15
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: Kelyniam Global, Inc. [Collinsville / United States of America]
KRS Global Biotechnology, Inc - Form 483, 2019-08-20
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: KRS Global Biotechnology, Inc [Boca Raton / United States of America]
SCHOTT Pharma AG & Co. KGaA - Form 483, 2019-08-14
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
KRS Global Biotechnology, Inc - EIR, 2019-08-14
$1190 - Available for instant download
Issued On: August, 2019
Inspection Type: EIR
Site Name: KRS Global Biotechnology, Inc [Boca Raton / United States of America]
Stefan W. Kreuzer, MD - Form 483, 2019-08-13
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: Stefan W. Kreuzer, MD [Houston / United States of America]
Fresenius Kabi USA, LLC - Form 483, 2019-08-12
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: Fresenius Kabi USA, LLC [Grand Island / United States of America]
Fresenius Kabi USA, LLC - EIR, 2019-08-12
$1190 - Available for instant download
Issued On: August, 2019
Inspection Type: EIR
Site Name: Fresenius Kabi USA, LLC [Grand Island / United States of America]
Sopakco Packaging - EIR, 2019-09-10
$1190 - Available for instant download
Issued On: August, 2019
Inspection Type: EIR
Site Name: Sopakco Packaging [Bennettsville / United States of America]
Fresenius Kabi USA, LLC - Form 483R, 2019-10-21
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483 Response
Site Name: Fresenius Kabi USA, LLC [Grand Island / United States of America]
Medoz Pharmacy of Polk Inc - Form 483, 2019-08-09
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: Medoz Pharmacy of Polk Inc [Davenport / United States of America]
Shanghai Kyowa Amino Acid Co.,Ltd - EIR, 2019-08-09
$1190 - Available for instant download
Issued On: August, 2019
Inspection Type: EIR
Site Name: Shanghai Kyowa Amino Acid Co.,Ltd [Qingpu / China]
Lake Chemicals Private Limited - Form 483, 2019-08-09
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Takeda Giken Service, Ltd. - Form 483, 2019-08-09
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Ekcomed LLC - Form 483, 2019-08-08
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: Ekcomed LLC [Saint Charles / United States of America]
Protek Medical Products, Inc. - Form 483, 2019-08-08
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: Protek Medical Products, Inc. [Coralville / United States of America]
Protek Medical Products, Inc. - EIR, 2019-09-03
$1190 - Available for instant download
Issued On: August, 2019
Inspection Type: EIR
Site Name: Protek Medical Products, Inc. [Coralville / United States of America]
Protek Medical Products, Inc. - Form 483R, 2019-08-21
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483 Response
Site Name: Protek Medical Products, Inc. [Coralville / United States of America]
PerkinElmer Medical Imaging - Form 483, 2019-08-08
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: PerkinElmer Medical Imaging [Santa Clara / United States of America]
Stickman Dialysis Industries, LLC - Form 483, 2019-08-08
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: Stickman Dialysis Industries, LLC [Kennebunkport / United States of America]
Ernest Jackson & Co Ltd - Form 483, 2019-08-08
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: Ernest Jackson & Co Ltd [Crediton / United Kingdom of Great Britain and Northern Ireland]
American Blood Bank Corp. - Form 483, 2019-08-07
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: American Blood Bank Corp. [Miami / United States of America]
Nippon Shikizai,inc. - Form 483, 2019-08-06
$289 - Available for instant download
Issued On: August, 2019
Inspection Type: FDA 483
Site Name: Nippon Shikizai,inc. [Wadai / Japan]
Mark Two Engineering Inc. - EIR, 2019-08-14
$1190 - Available for instant download
Issued On: August, 2019
Inspection Type: EIR
Site Name: Mark Two Engineering Inc. [Miami Lakes / United States of America]