FDA Form 483 Records
Browse through 17,220 fda form 483 records and compliance documents. Access detailed regulatory information to stay informed about industry trends and compliance requirements.
Showing 20 of 17,220 records
Record fcb4d6b8
Product: biologics
Office: Chicago District Office
People: Peng Zhou, Shafiq Ahadi
Violations: 2 code(s)
Sentiss Pharma Pvt. Ltd.
Product: drugs
Office: Foreign - CDER (Bioresearch Monitoring)
People: Sandra A. Hughes, Eileen A. Liu
C.A.T. GmbH and Co. KG
Product: drugs
Office: Foreign - CDER (Bioresearch Monitoring)
People: Elizabeth L. Edwards (investigator)
MSN LIFE SCIENCES PRIVATE LIMITED
Product: drugs
Office: Center for Drug Evaluation and Research
People: Steven A. Brettler (Consumer Safety Officer)
SNJ Labs Pvt. Ltd.
Product: drugs
Office: Center for Drug Evaluation and Research
People: Paranthaman Senthamarai Kannan
Zydus Lifesciences Limited
Product: drugs
Office: Center for Drug Evaluation and Research
People: Jessica S. Estriplet (Drug Investigator), Brandy N. Lepage (Consumer Safety Officer)
Emcure Pharmaceuticals Limited
Product: drugs
Office: Center for Drug Evaluation and Research
People: Brandy N. Lepage (Consumer Safety Officer), Jessica S. Estriplet (Drug Investigator)
Kite Pharma, Inc.
Product: biologics
Office: Los Angeles District Office
People: Peng Zhou, Shafiq S. Ahadi (Investigator), Shafiq Ahadi
Fresenius Medical Care Renal Therapies Group, LLC
Product: device
Office: Office of Medical Device and Radiological Health Operations
People: Maura Rooney (issuing_officer)
Fresenius Medical Care Holdings, Inc.
Product: device
Office: Center for Veterinary Medicine
People: Michael J. Muldoon, Mark W. Russell, Michael D. Howell
Kimberly-Clark Corporation
Product: device
Office: Division of Advertising & Promotion
People: Herbert P. Lerner, M.D.
Atmos Medizintechnik Gmbh & Co. KG
Product: device
Office: Division of Pharmaceutical Quality Operations IV
People: David Lennarz, Michael J. Shaffer
Murphy Brown LLC
Product: veterinary
Office: Kansas City District Office
People: Makenzie B Schwalm, Morgan E. Ferbert
Famous Brands Management Company (Pty) Ltd
Product: other
Office: Office of Inspections and Investigations
People: Tressa T. Lewis (investigator)
Bioreliance Ltd.
Product: drugs
Office: Office of Inspections and Investigations
People: Travis S. Bradley, Lewis K. Antwi
Island Kinetics, Inc. d.b.a. CoValence Laboratories
Product: drugs
Office: Denver District Office
People: Nicholas L. Hunt (Senior CSO, Investigator), Hung H. Do
Compass Health Brands Corp.
Product: device
Office: Cincinnati District Office
People: Laureen M. Geniusz (Investigator )
Axsome Therapeutics, Inc.
Product: drugs
Office: New York District Office
People: Roberto A. Dookhan, Omadevi Somai, Kerun Hardeo
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