FDA Form 483s directory

All fda form 483s17,220 total

• Cosco Enterprises Inc.2024-03-26
• UniSoft Medical Corporation2023-01-19
• Agiliti Health - Ellis2023-11-02
• Arzol Chemical Company2024-07-14
• Abbott Vascular2023-11-16
• Nexgen Pharma Inc2018-08-17
• Happy Farm Botanicals2024-03-15
• Ophthalmic Labs, Inc.2024-04-09
• Alejandro (NMI) Hoberman, M.D.2024-06-18
• AGCO Hay LLC2024-04-04
• Lummacups LLC2023-01-19
• Bard Shannon Limited2023-08-18
• Technicuff Corp.2024-04-24
• Dalton Chemical Laboratories Inc.2022-12-09
• Gyrus ACMI, Inc.2026-11-02
• Biocon Biologics Limited2024-07-26
• BioMarin Pharmaceuticals, Inc.2024-12-13
• Genus Lifesciences Inc.2024-12-13
• ESTABLISHMENT LABS SA2024-07-24
• Medtronic Puerto Rico Operations Company2011-03-11
• Ecotec Manufacturing, Inc.2023-04-18
• Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site)2013-07-18
• XGen Pharmaceuticals DJB, Inc.2024-07-14
• Purisys LLC2024-03-13
• Eversight Illinois2024-06-18
• Cerner Corp2017-06-21
• SRS Medical Systems Inc.2023-10-11
• Kindeva Drug Delivery LP2024-04-03
• Samsung Biologics Co., Ltd.2024-07-30
• CEP Bio-Coat, LLC2022-10-12
• Rosario Hidalgo, MD2026-12-04
• Regis Technologies, Inc.2022-11-16
• Tianjin Asymchem Pharmaceuticals Co., Ltd.2024-03-29
• American Spraytech LLC2024-04-11
• Gland Pharma Limited, Units I+II Pashamylaram Site2024-08-02
• Amphastar Pharmaceuticals, Inc.2024-03-01
• LiquidCapsule Manufacturing, LLC2024-02-09
• Central Indiana Ethanol LLC2024-04-24
• Carefusion 2200 Inc2022-10-11
• Felix Generics Private Limited2024-08-27
• Dexcom, Inc.2024-11-07
• Rechon Life Science AB2024-09-06
• Veterans Administration Long Beach Healthcare System IRB2019-05-17
• Howard University Institutional Review Board2022-05-19
• UCLA Medical IRB 1 (OHRPP)2019-06-26
• NEUROLOGICAL FITNESS EQUIPMENT and EDUCATION LLC, dba NEUFIT2024-07-03
• MPP GROUP, LLC2024-06-07
• St. Agnes Medical Center IRB2022-09-01
• Legacy Health IRB2021-12-17
• Eastern Cranial Affiliates, LLC2024-06-13
• Baylab USA, LLC2024-01-31
• Roslin Cell Therapies Limited2023-08-04
• LGM Pharma Solutions, LLC2024-03-01
• SUMAR BIOTECH LLP2024-01-12
• WHPM Inc.2024-01-30
• Mylan Laboratories Limited2026-07-22
• Vege Labs LLC2025-03-18
• Institute of Regenerative and Cellular Medicine2021-10-19
• iRhythm Technologies, Inc.2024-07-31
• iRhythm Technologies Inc2024-07-31
• Charles River Laboratories Inc.2024-03-15
• Janssen Biotech, Inc2024-09-27
• Otsuka Pharmaceutical Co., Ltd.2026-06-17
• Pedro A. Velasquez-Mieyer, M.D.2024-09-13
• Ceva Animal Health2018-11-09
• Sharp Clinical Services, LLC2022-09-02
• Laboratorio Reig Jofre S.A.2023-06-23
• Intervet Mexico S.A. de C.V. - MSD Animal Health2020-02-14
• LifeBridge Health, Inc. IRB2019-03-13
• Boehringer Ingelheim BioPharmaceuticals (China) Ltd.2023-07-09
• Avox Systems Inc2024-02-02
• BK Medical Holding Company2022-05-27
• GLOBAL FERTILITY & GENETICS2022-10-19
• Tianjin Asymchem Pharmaceuticals Co., Ltd.2021-10-19
• Catalent Maryland Inc2023-03-10
• Alembic Pharmaceuticals Limited2024-11-22
• Amneal Pharmaceuticals Private Ltd.2024-07-19
• Baxter Healthcare Corporation2024-07-19
• Shanghai Kyowa Amino Acid Co., Ltd.2023-12-15
• Novartis Singapore Pharmaceutical Manufacturing Pte.2020-02-15
• Intas Pharmaceuticals Limited2023-12-07
• Dr. Reddy's Laboratories Limited (Unit II)2024-11-19
• CSL Behring (Australia) Pty Ltd2024-03-08
• Nosch Labs Private Ltd2024-09-13
• Ascension Sacred Heart Hospital IRB2022-08-10
• Memorial Hospital of Rhode Island IRB2019-04-17
• Patheon Italia S.p.A.2021-09-03
• Applied Therapeutics, Inc.2024-05-03
• Kovas Co., Ltd.2019-11-22
• Kovas Co., Ltd.2024-11-29
• Yiling Pharmaceutical Ltd.2024-10-11
• Micro-Macinazione SA2019-05-31
• Edward Food Research & Analysis Centre Limited2024-07-19
• Hubei Gedian Humanwell Pharmaceutical Co., Ltd.2013-10-17
• Hubei Gedian Humanwell Pharmaceutical Co., Ltd.2016-05-13
• Harman Finochem Limited2024-03-22
• Martin E. Gutierrez2024-11-20
• Ethical Nutritional, LLC dba Remedy Makers2024-12-05
• Ningbo Shuangcheng Pharmaceutical Co., Ltd.2023-11-03
• Seaway Pharma Inc.2024-07-24