Recent USFDA Warning Letters Released for November 2024

Date Listed Date of Letter Name of Company Issuing Department Topic
11/05/2024 06/03/2024 Top Health Manufacturing, LLC Division of Human and Animal Food Operations West IV CGMP/Dietary Supplement/Adulterated
11/05/2024 10/10/2024 Analytical Food Laboratories, Inc. Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
11/05/2024 10/22/2024 Ardent Animal Health, LLC Center for Veterinary Medicine Unapproved New Animal Drug Products
11/05/2024 10/29/2024 Armstrong County Memorial Hospital Center for Drug Evaluation and Research (CDER) Institutional Review Board (IRB)
11/05/2024 10/24/2024 Fancy Drops Beauty LLC Center for Drug Evaluation and Research (CDER) Unapproved New Drugs/Misbranded
11/06/2024 11/04/2024 Global Source Distribution, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
11/08/2024 10/18/2024 Rolence Ent. Inc. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated
11/08/2024 09/10/2024 Micro-X Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated
11/08/2024 11/06/2024 Daddy’s Vapor Distro Inc. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
11/12/2024 11/07/2024 Zhejiang Qimei Cosmetics Co., Ltd. Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
11/12/2024 11/01/2024 Owens & Minor, Inc. dba American Contract Systems, Inc. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated
11/12/2024 11/05/2024 Multaler et Cie SAS Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
11/12/2024 05/31/2024 Rongcheng Jiayuan Food Co., Ltd Center for Food Safety and Applied Nutrition (CFSAN) Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
11/19/2024 11/06/2024 Unexo Lifesciences, Private Limited Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
11/19/2024 11/05/2024 Colgate-Palmolive/Tom’s of Maine, Inc. Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
11/19/2024 11/07/2024 Originitalia SRL Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
11/19/2024 10/30/2024 Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
11/19/2024 11/01/2024 Frontier Biologics, LLC Center for Biologics Evaluation and Research Unapproved New Drug/Unlicensed Biological Product Violations
11/19/2024 11/06/2024 Richard W. Foltin, Ph.D. Center for Drug Evaluation and Research (CDER) Clinical Investigator (Sponsor)
11/19/2024 05/13/2024 Golden Shrimp Seafood Joint Stock Company Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
11/26/2024 10/11/2024 Adept Medical Ltd. Center for Devices and Radiological Health CGMP/QSR/Medical Devices/Adulterated/Misbranded
11/26/2024 11/18/2024 Hangzhou Huiji Biotechnology Co., Ltd. Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
11/26/2024 06/24/2024 Advance Nature Sdn Bhd Center for Food Safety and Applied Nutrition Low Acid Canned Food Regulation/Adulterated
11/26/2024 08/13/2024 Agustson A/S Center for Food Safety and Applied Nutrition Acidified Foods/Emergency Permit Control/Adulterated
11/26/2024 11/20/2024 Eurosirel S.P.A Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
11/26/2024 03/06/2024 Procesadora Vikingo C.A. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
11/26/2024 11/18/2024 Stew Leonard’s Holdings LLC Human Foods Program Food Labeling/Misbranded
11/26/2024 10/17/2024 Maruhachi Muramatsu Inc., Danchi Factory Human Foods Program Seafood HACCP/CGMP for Foods/Adulterated
11/26/2024 11/15/2024 Centura Pharmaceuticals Inc Center for Drug Evaluation and Research (CDER) Finished Pharmaceuticals/Unapproved New Drug/Misbranded
11/26/2024 10/17/2024 Grupo VPAS C.A. Human Foods Program Seafood HACCP/CGMP for Foods/Adulterated
11/26/2024 10/25/2024 Rise N’ Shine Farm, Inc. Human Foods Program PHS Act/Shell Egg Regulation/Adulterated
11/26/2024 08/30/2024 Kyokuyo Global Seafoods Co. LTD. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated
11/26/2024 08/28/2024 Barohup Inc. Division of West Coast Imports Foreign Supplier Verification Program (FSVP)
11/26/2024 11/21/2024 Catwalk Cosmetic Laboratories Pty Ltd. Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
11/26/2024 10/29/2024 Tova Industries, LLC Human Foods Program Acidified Foods/Emergency Permit Control/Adulterated