USFDA Releases September 2024 Warning Letters

Date Posted Date Issued Organization Issuing Division Category
09/03/2024 08/19/2024 Kaylaan LLC Division of Pharmaceutical Quality Operations I CGMP/Adulterated Pharmaceuticals
09/03/2024 08/16/2024 EBCREATE Store Center for Tobacco Products Tobacco Act/Misbranded
09/03/2024 08/01/2024 Dasada Group LLC Division of Southwest Imports FSVP
09/03/2024 08/27/2024 Everymarket Inc. Center for Drug Evaluation and Research (CDER) Unapproved/Misbranded Drugs
09/03/2024 08/22/2024 Parallel Direct LLC d/b/a The Magic Mist Center for Tobacco Products Tobacco Act/Misbranded
09/03/2024 08/13/2024 Waiakea Bottling Inc. Division of Human and Animal Food Operations West V CGMP/Water Regulations
09/03/2024 08/20/2024 Mother Stem Institute, Corp. Center for Biologics Evaluation and Research (CBER) HCT/Ps Deviations
09/03/2024 08/14/2024 Graceleigh, Inc. dba Sammy’s Milk Division of Human and Animal Food Operations West V Food Mislabeling
09/03/2024 08/20/2024 Julio R. Flamini, M.D./Clinical Integrative Research Center of Atlanta Center for Drug Evaluation and Research (CDER) Clinical Investigator
09/03/2024 08/27/2024 SoloVital Center for Drug Evaluation and Research (CDER) Unapproved/Misbranded Drugs
09/03/2024 08/27/2024 MexHealth LLC d/b/a Al Natural E-Shop Center for Drug Evaluation and Research (CDER) Unapproved/Misbranded Drugs
09/06/2024 08/16/2024 Regenerative Processing Plant, LLC Center for Biologics Evaluation and Research CGMP/Adulterated Pharmaceuticals
09/10/2024 08/29/2024 Zydus Lifesciences Limited Center for Drug Evaluation and Research (CDER) CGMP/Adulterated Pharmaceuticals
09/10/2024 08/29/2024 Orean Personal Care Ltd. Center for Drug Evaluation and Research (CDER) CGMP/Adulterated Pharmaceuticals
09/10/2024 09/05/2024 Master Sales LLC Center for Tobacco Products Tobacco Act/Misbranded
09/10/2024 08/13/2024 Optikem International, Inc. Center for Devices and Radiological Health CGMP/Medical Devices
09/10/2024 09/03/2024 Avaria Health & Beauty Corp. Center for Drug Evaluation and Research (CDER) CGMP/Adulterated Pharmaceuticals
09/10/2024 08/22/2024 California Veterinary Supply Center for Veterinary Medicine Unapproved Antimicrobials
09/10/2024 08/30/2024 Root Bioscience Brands, LLC dba Naternal Center for Drug Evaluation and Research (CDER) Unapproved/Misbranded Drugs
09/11/2024 09/10/2024 Sanitation & Environmental Technology Institute dba SDWH Center for Devices and Radiological Health IDE/PMA
09/11/2024 09/10/2024 Mid-Link Testing Company, Ltd Center for Devices and Radiological Health IDE/PMA
09/13/2024 09/12/2024 Quad Life USA Inc. Center for Tobacco Products Tobacco Act/Misbranded
09/13/2024 09/12/2024 Beard Management Inc. d/b/a Beard Vape Co. d/b/a Lucky Bar Holdings, d/b/a Fifty Bar Center for Tobacco Products Tobacco Act/Misbranded
09/13/2024 09/12/2024 Shenzhen Greensound High-Tech Co. Ltd. d/b/a ENVA Center for Tobacco Products Tobacco Act/Misbranded
09/13/2024 09/12/2024 Breeze Smoke Official Center for Tobacco Products Tobacco Act/Misbranded
09/13/2024 09/12/2024 Mr Fog Switch Center for Tobacco Products Tobacco Act/Misbranded
09/13/2024 09/12/2024 MR FOG d/b/a MR FOG Officials Center for Tobacco Products Tobacco Act/Misbranded
09/13/2024 09/12/2024 SS Vape Brands Inc. d/b/a Monster Vape Labs d/b/a The Monster Group Center for Tobacco Products Tobacco Act/Misbranded
09/13/2024 09/12/2024 FUNCOOL Technology Co., Limited d/b/a RAZ Vape Center for Tobacco Products Tobacco Act/Misbranded
09/13/2024 09/12/2024 Sweet TSV 1 d/b/a Sweet Vape Shop Center for Tobacco Products Tobacco Act/Misbranded
09/13/2024 09/12/2024 Bugatti Vape, LLC Center for Tobacco Products Tobacco Act/Misbranded
09/13/2024 09/12/2024 Mery Vape Center for Tobacco Products Tobacco Act/Misbranded
09/16/2024 09/12/2024 Exotic Wholesale LLC Center for Tobacco Products Tobacco Act/Misbranded
09/17/2024 08/12/2024 Greco Gas, Inc. Office of Pharmaceutical Quality CGMP/Adulterated Pharmaceuticals
09/17/2024 09/11/2024 Quality CDMO, Inc. Center for Drug Evaluation and Research (CDER) Unapproved Drugs
09/17/2024 09/09/2024 EnviroServe Chemicals & Cleaners Ltd. Center for Drug Evaluation and Research (CDER) CGMP/Misbranded/Unapproved
09/17/2024 03/21/2024 St. Louis Calco, LLC Division of Human and Animal Food Operations West II Food Safety Issues
09/17/2024 07/17/2024 TJA Health, LLC Division of Pharmaceutical Quality Operations III CGMP/Adulterated Pharmaceuticals
09/17/2024 09/10/2024 Aromas Para El Alma S.A. Center for Drug Evaluation and Research (CDER) CGMP/Misbranded/Unapproved
09/24/2024 07/24/2024 Aerosol and Liquid Packaging, Inc. Division of Pharmaceutical Quality Operations I CGMP/Adulterated Pharmaceuticals
09/24/2024 09/12/2024 Nomida.biz Center for Drug Evaluation and Research (CDER) Unapproved/Misbranded Drugs
09/24/2024 09/20/2024 Azurity Pharmaceuticals, Inc. Center for Drug Evaluation and Research (CDER) CGMP/Misbranded/Unapproved
09/24/2024 08/06/2024 Wittman Pharma, Inc. Division of Pharmaceutical Quality Operations II CGMP/Adulterated Pharmaceuticals
09/24/2024 04/25/2024 Brewing Market Coffee Division of Human and Animal Food Operations West IV Acidified Foods Control
09/24/2024 08/13/2024 Restorative Botanicals, LLC Division of Human and Animal Food Operations West IV CGMP/Dietary Supplement
09/24/2024 07/24/2024 Warbucks Seafood NY LLC Division of Northeast Imports FSVP
09/24/2024 08/15/2024 Accupack Midwest, Inc. Division of Pharmaceutical Quality Operations III CGMP/Adulterated Pharmaceuticals
09/27/2024 09/25/2024 Southeast Distro Inc. Center for Tobacco Products Tobacco Act/Misbranded