FDA Form 483 Records
Browse through 4,860 fda form 483 records and compliance documents. Access detailed regulatory information to stay informed about industry trends and compliance requirements.
Showing 20 of 4,860 records
Boehringer Ingelheim Animal Health do Brasil Ltda.
Product: Veterinary
Office: Office of Inspections and Investigations
People: Ileana Barreto-pettit
Allergan Pharmaceuticals Ireland
Product: drugs
People: Thuy Nguyen ( Investigator, Consumer Safety Officer), Kejun Cheng (other)
EUGIA Pharma Specialities Limited
Product: drugs
People: Matthew B. Casale ( Investigator ), Joseph A. Piechocki
Barr Laboratories Inc.
Product: biologics
Office: Office of Regulatory Affairs
People: Scott T. Ballard
Enestia Belgium NV
Product: drugs
Office: Center for Biologics Evaluation and Research
People: Lewis K. Antwi, Peng Zhou
VRL Eurofins
Product: biologics
Office: San Francisco District Office
People: William Lagud (Investigator), Lesley Mae P Lutao
Global Calcium Pvt. Limited
Product: drugs
People: Alan A. Rivera, Jose E. Melendez (Quality System Specialist)
Violations: 2 code(s)
Lonza AG
Product: drugs
Office: Division of Biotechnology Manufacturing
People: Reyes Candau-Chacon (investigator), Ralph M. Bernstein, Lei Zhang
Merck Teknika LLC
Product: biologics
Office: Atlanta District Office
People: Unnee Ranjan (Investigator), Lizaida Perez (FDA_PERSONNEL), Brentley S. Pittman
WuXi ATU Co., Ltd.
Product: biologics
Office: Division of Manufacturing and Product Quality
People: Viviana Ramirez, Timothy Kamaldinov, Massoud Motamed (Biologist at CBER)
Immucor, Inc.
Product: devices
Office: Atlanta District Office
People: Cody D. Rickman, Emilia A. Sippert (FDA_PERSONNEL), Kimberly M. Bigler (FDA_PERSONNEL)
Ferring Microbiome Inc.
Product: biologics
Office: Minneapolis District Office
People: Laurel Beer, Scott T. Ballard
Harper University Hospital
Product: biologics
Office: Detroit District Office
People: Chanel E. Crawford (FDA_PERSONNEL), Matthew J Gretkierewicz (issuing_officer)
Versiti Michigan Inc
Product: biologics
Office: Detroit District Office
People: Matthew J Gretkierewicz (issuing_officer)
GenIbet Biopharmaceuticals, S.A.
Product: biologics
Office: Center for Biologics Evaluation and Research
People: Unnee Ranjan (Investigator), Burnell M. Henry (Investigator)
VET4U, LLC
Product: drugs
Office: New York District Office
People: Sarah E. Venti (Regulatory Counsel at Food and Drug Administration, Center for Drug Evaluation and Research), Armen H. Youssoufian, Ogechi C Nna
Violations: 2 code(s)
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