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Rush University System for Health IRB - Form 483, 2025-09-12
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Rush University Medical Center IRB [Chicago / United States of America]
Higley Industries, Inc. - Form 483, 2025-09-12
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Higley Industries, Inc. [Dyersville / United States of America]
Nippon Shikizai,inc. - Form 483, 2025-09-12
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Nippon Shikizai,inc. [Wadai / Japan]
Immunologix Laboratories - Form 483, 2025-09-12
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: IMMUNOLOGIX LABORATORIES [Tampa / United States of America]
Zhejiang Shenzhou Pharmaceutical Co., Ltd - Form 483, 2025-09-12
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Zhejiang Shenzhou Pharmaceutical Co., Ltd. [Xianju / China]
Cosmax Usa, Corporation - Form 483, 2025-09-12
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Cosmax Usa, Corporation [Carteret / United States of America]
USV Private Limited - Form 483, 2025-09-12
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: USV Private Limited [Khed / India]
rms Company - Form 483, 2025-09-12
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: rms Company [Minneapolis / United States of America]
BioLyte Laboratories, LLC - Form 483, 2025-09-12
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: BioLyte Laboratories, LLC [Grand Rapids / United States of America]
Xenova Sciences, LLC - EIR, 2025-10-17
$1190 - Available for instant download
Issued On: September, 2025
Inspection Type: EIR
Site Name: Xenova Sciences, LLC [Gretna / United States of America]
Haribo Food 2004 Inc. - Form 483, 2025-09-12
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: HARIBO FOOD 2004 INC [Hialeah / United States of America]
Ningxia Qiyuan Pharmaceutical Co., Ltd. - Form 483, 2025-09-12
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Ningxia Qiyuan Pharmaceutical Co., Ltd. [Wangyuan / China]
Ajinomoto Health & Nutrition North America, Inc. - Form 483, 2025-09-12
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Ajinomoto Health & Nutrition North America Inc [Eddyville / United States of America]
Bradshaw Medical, Inc. - Form 483, 2025-09-12
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Bradshaw Medical, Inc. [Kenosha / United States of America]
FLOWCHEM PHARMA PRIVATE LIMITED - Form 483, 2025-09-12
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: FLOWCHEM PHARMA PRIVATE LIMITED [Hindupur / India]
Croda Europe Ltd. - Form 483, 2025-09-12
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Croda Europe Ltd. [Staffordshire Moorlands / United Kingdom of Great Britain and Northern Ireland]
Merck Sharp & Dohme LLC - Form 483, 2025-09-12
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Merck Sharp & Dohme LLC [Wilson / United States of America]
Shire Human Genetic Therapies, Inc. - Form 483, 2025-09-12
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Shire Human Genetic Therapies, Inc. [Cambridge / United States of America]
Specialty Formulations and Manufacturing LLC - Form 483, 2025-09-12
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Specialty Formulations and Manufacturing LLC [Phoenix / United States of America]
Virbac AH, Inc - Form 483, 2025-09-17
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Virbac AH, Inc [Roanoke / United States of America]
Ridley USA Inc. - Form 483, 2025-09-12
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Ridley USA Inc. [Fort Worth / United States of America]
JHK Inc dba American Safety & First Aid - Form 483, 2025-09-11
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: JHK Inc dba American Safety & First Aid [Osceola / United States of America]
Precision Optics Corporation, Inc. - Form 483, 2025-09-11
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Precision Optics Corporation, Inc. [Gardner / United States of America]
Precision Dose Inc. - Form 483, 2025-09-11
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Precision Dose Inc. [South Beloit / United States of America]
BEIJING RUICHENG MEDICAL SUPPLIES CO., LTD. - Form 483, 2025-09-11
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: BEIJING RUICHENG MEDICAL SUPPLIES CO., LTD. [Huairou / China]
C K Frozen Fish and Food Inc. - Form 483, 2025-09-11
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: C K Frozen Fish and Food Inc. [Jamaica / United States of America]
Eli Lilly and Company - Form 483, 2025-09-11
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Eli Lilly and Company [Kenosha / United States of America]
Boehringer Ingelheim Pharmaceuticals, Inc. - Form 483, 2025-09-11
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Boehringer Ingelheim Pharmaceuticals, Inc. [Ridgefield / United States of America]
Quirch Foods Southeast LLC - Form 483, 2025-09-11
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Quirch Foods Southeast LLC [Greensboro / United States of America]
Diversified Healthcare Development LLC - Form 483, 2025-09-11
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Core Health and Fitness, LLC [Independence / United States of America]
Unette Corporation - Form 483, 2025-09-11
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Unette Corporation [Randolph / United States of America]
Tropichem Research Labs, LLC dba Vetio - Form 483, 2025-09-11
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Tropichem Research Labs, LLC dba Vetio [Jupiter / United States of America]
Natalia E. Castillo Almeida, MD - Form 483, 2025-09-11
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Natalia Castillo Almeida [Omaha / United States of America]
Areva Pharmaceuticals Inc - Form 483, 2025-09-11
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Areva Pharmaceuticals Inc [Georgetown / United States of America]
OXYGEN DEVELOPMENT, L.L.C. - Form 483, 2025-09-11
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: OXYGEN DEVELOPMENT, L.L.C. [West Palm Beach / United States of America]
Hege Farm, LLC - Form 483, 2025-09-10
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Hege Farm, LLC [Midville / United States of America]
NewYork-Presbyterian/Weill Cornell Medical Center - Form 483, 2025-09-10
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: New York Presbyterian Hospital Services [New York / United States of America]
MSD International GmbH (Puerto Rico Branch) LLC - Form 483, 2025-09-10
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: MSD International GmbH (Puerto Rico Branch) LLC [Montones / Puerto Rico]
Diamond S Dairy - Form 483, 2025-09-10
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Diamond S Dairy [Hanford / United States of America]
Frank Gwerder Dairy Inc. - Form 483, 2025-09-10
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Gwerder, Frank Jr. [Modesto / United States of America]
Molecular Therapeutics LLC - Form 483, 2025-09-10
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Molecular Therapeutics Production [Athens / United States of America]
Deirdre O. Hooper, M.D. - Form 483, 2025-09-10
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Deirdre O. Hooper, M.D. [New Orleans / United States of America]
Cyclotron Facility University of Pennsylvania - EIR, 2025-10-23
$1190 - Available for instant download
Issued On: September, 2025
Inspection Type: EIR
Site Name: Cyclotron Facility University of Pennsylvania [Philadelphia / United States of America]
LifeSouth Community Blood Centers Inc - Form 483, 2025-09-10
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: LifeSouth Community Blood Centers Inc [Madison / United States of America]
Charles River Laboratories, Inc. - Form 483, 2025-09-09
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Charles River Laboratories, Inc. [Wilmington / United States of America]
Boston IVF Fertility Services at The Women's Hospital, LLC - Form 483, 2025-09-09
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Boston IVF at The Women's Hospital [Newburgh / United States of America]
Charles River Laboratories, Inc. - Form 483R, 2025-09-25
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483 Response
Site Name: Charles River Laboratories, Inc. [Wilmington / United States of America]
Charles River Laboratories, Inc. - EIR, 2025-09-16
$1190 - Available for instant download
Issued On: September, 2025
Inspection Type: EIR
Site Name: Charles River Laboratories, Inc. [Wilmington / United States of America]
Juicer Connections, Inc. - Form 483, 2025-09-08
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Juicer Connections, Inc. [Vernon / United States of America]
Hoxworth Blood Center University of Cincinnati - Form 483, 2025-09-08
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Hoxworth Blood Center University of Cincinnati [Cincinnati / United States of America]
Design and Services Hub - Form 483, 2025-09-08
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: DESIGN AND SERVICES HUB, LLC [Hartville / United States of America]
ARROW INTERNATIONAL, LLC - Form 483, 2025-09-08
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Issam Makhoul - Form 483, 2025-09-08
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Issam Makhoul [Little Rock / United States of America]
Aurobindo Pharma Limited - Form 483, 2025-09-05
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Aurobindo Pharma Limited [Hyderabad / India]
International Chemical Entity Japan Co.,Ltd. - Form 483, 2025-09-05
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: International Chemical Entity Japan Co.,Ltd. [Jobammisawamachi / Japan]
AZICO BIOPHORE INDIA PRIVATE LIMITED - Form 483, 2025-09-05
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: AZICO BIOPHORE INDIA PRIVATE LIMITED [Paravada / India]
Viking Mississippi - Form 483, 2025-09-05
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Viking Mississippi [Red Wing / United States of America]
A Plus International, Inc - Form 483, 2025-09-05
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: A Plus International Inc [Chino / United States of America]
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding - Form 483, 2025-09-05
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Zydus Lifesciences Limited - Form 483, 2025-09-05
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
PETNET SOLUTIONS, INC. - Form 483, 2025-09-05
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: PETNET SOLUTIONS, INC. [Overland Park / United States of America]
Matrix Pharmacorp Private Limited - Form 483, 2025-09-05
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Tianish Laboratories Private Limited [Paravada / India]
LUPIN LIMITED - Form 483, 2025-09-05
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: LUPIN LIMITED [Aurangabad / India]
Central Admixture Pharmacy Services, Inc. - Form 483, 2025-09-05
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Central Admixture Pharmacy Services, Inc. [Allentown / United States of America]
FARMAKEIO OUTSOURCING LLC - Form 483, 2025-09-05
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: FARMAKEIO OUTSOURCING LLC [Southlake / United States of America]
BSN Medical Inc - Form 483, 2025-09-05
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: BSN Medical Inc [Charlotte / United States of America]
Dr. Reddy's Laboratories (EU) Ltd. - Form 483, 2025-09-05
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Dr. Reddy's Laboratories (EU) Ltd. [Mirfield / United Kingdom of Great Britain and Northern Ireland]
Central Admixture Pharmacy Services, Inc. - Form 483, 2025-09-05
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Central Admixture Pharmacy Services, Inc. [Phoenix / United States of America]
Robert G. Perry, M.D. - Form 483, 2025-09-05
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Robert G Perry [Miami / United States of America]
Janssen Pharmaceutica NV - Form 483, 2025-09-05
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Janssen Pharmaceutica NV [Beerse / Belgium]
MRIAUDIO, INC. - Form 483, 2025-09-05
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: MRIAUDIO, INC. [Carlsbad / United States of America]
Advin Biotech, Inc. - Form 483, 2025-09-05
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Advin Biotech, Inc. [San Diego / United States of America]
Hammock Dairy Farms Inc. - Form 483, 2025-09-04
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Hammock Dairy Farms Inc. [Chatham / United States of America]
Sparsha Pharma USA, Inc. - Form 483, 2025-09-04
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Sparsha Pharma USA, Inc. [Oceanside / United States of America]
Qualgen, LLC - Form 483, 2025-09-04
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Jackson Dairy LLC - Form 483, 2025-09-04
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Jackson Dairy LLC [Hanford / United States of America]
SM Rendering, Inc. - Form 483, 2025-09-04
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: SM Rendering, Inc. [Utica / United States of America]
Pharmgate Inc. - Form 483, 2025-09-04
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Pharmgate Inc. [Omaha / United States of America]
Barohup Inc. - Form 483, 2025-09-04
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
United-Guardian, Inc. - Form 483, 2025-09-04
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: United-Guardian, Inc. [Hauppauge / United States of America]
Clearadvance, LLC - Form 483, 2025-09-04
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: CLEARADVANCE, LLC [Irvine / United States of America]
Lexenpharm (Suzhou) Limited - Form 483, 2025-09-04
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Lexenpharm (Suzhou) Limited [Suzhou / China]
Biocon Biologics Limited - Form 483, 2025-09-03
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Biocon Biologics Limited [Bengaluru / India]
Cornerstone Medical Associates, Inc. - Form 483, 2025-09-03
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Sequoia Surgical Inc [Fresno / United States of America]
National Railroad Passenger Corporation (AMTRAK) - Form 483, 2025-09-03
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: National Railroad Passenger Corporation (AMTRAK) [Washington / United States of America]
Meditco, Inc. D.B.A. Phoenicia Specialty Foods - Form 483, 2025-09-04
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Meditco, Inc. D.B.A. Phoenicia Specialty Foods [Houston / United States of America]
SOFIE Co. dba SOFIE - Form 483, 2025-09-03
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: SOFIE Co. dba SOFIE [Kansas City / United States of America]
VEOS USA, Inc. - Form 483, 2025-09-03
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Crimson Holdings, LLC [Adrian / United States of America]
Charles River Laboratories Edinburgh Limited - Form 483, 2025-09-02
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
PETNET SOLUTIONS, INC. - Form 483, 2025-09-02
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: PETNET SOLUTIONS, INC. [North Wales / United States of America]
Kreitchman PET Center - Form 483, 2025-09-02
$289 - Available for instant download
Issued On: September, 2025
Inspection Type: FDA 483
Site Name: Kreitchman PET Center [New York / United States of America]
Central California Blood Center - Form 483, 2025-08-29
$289 - Available for instant download
Issued On: August, 2025
Inspection Type: FDA 483
Site Name: Central California Blood Center [Fresno / United States of America]
CPM Medical Consultants, LLC. - Form 483, 2025-08-29
$289 - Available for instant download
Issued On: August, 2025
Inspection Type: FDA 483
Site Name: CPM MEDICAL [Richardson / United States of America]
Careox, Llc - Form 483, 2025-08-29
$289 - Available for instant download
Issued On: August, 2025
Inspection Type: FDA 483
Site Name: CAREOX LLC [Princeton / United States of America]
KCAS, LLC - Form 483, 2025-08-29
$289 - Available for instant download
Issued On: August, 2025
Inspection Type: FDA 483
Site Name: Integris Bioservices LLC [Shawnee / United States of America]
Minteq U K LTD - Form 483, 2025-08-29
$289 - Available for instant download
Issued On: August, 2025
Inspection Type: FDA 483
Site Name: Minteq U K LTD [Birmingham / United Kingdom of Great Britain and Northern Ireland]
Apitoria Pharma Private Limited - Form 483, 2025-08-29
$289 - Available for instant download
Issued On: August, 2025
Inspection Type: FDA 483
Site Name: Apitoria Pharma Private Limited [Hathnoora / India]
Creative Testing Solutions - Form 483, 2025-08-29
$289 - Available for instant download
Issued On: August, 2025
Inspection Type: FDA 483
Site Name: Creative Testing Solutions [Tempe / United States of America]
Bio-Medical Pharmaceutical Manufacturing Corporation - Form 483, 2025-08-29
$289 - Available for instant download
Issued On: August, 2025
Inspection Type: FDA 483
Site Name: Bio-Medical Pharmaceutical Manufacturing Corporation [Houston / United States of America]
SGS France - Form 483, 2025-09-29
$289 - Available for instant download
Issued On: August, 2025
Inspection Type: FDA 483
Site Name: SGS France [Arcueil / France]