Recent USFDA Warning Notices Released for October 2024

Date Released Date of Issue Business Name Office of Issue Topic
10/01/2024 08/13/2024 NRS Enterprises, Inc. d/b/a Sunflour Bakery Division of Human and Animal Food Operations West V CGMP/Food/Prepared, Packed or Held Under Unsanitary Conditions/Adulterated
10/01/2024 09/20/2024 Shake Hemp Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/01/2024 09/06/2024 Diamond Chemical Co., Inc. Division of Pharmaceutical Quality Operations I CGMP/Finished Pharmaceuticals/Adulterated
10/01/2024 09/11/2024 Healthwest Minerals, Inc. dba Mt. Capra Products Division of Human and Animal Food Operations West VI Interstate Commerce/Food/Adulterated
10/01/2024 09/04/2024 Troya Del Campo USA LLC Division of Southwest Imports Foreign Supplier Verification Program (FSVP)
10/01/2024 09/11/2024 JJH Trading Inc. Division of West Coast Imports Foreign Supplier Verification Program (FSVP)
10/01/2024 09/13/2024 Far East Summit LLC Division of Human and Animal Food Operations West VI Unapproved New Drugs/Misbranded
10/01/2024 09/12/2024 Pacific Exchange Distributors LLC Division of West Coast Imports Foreign Supplier Verification Program (FSVP)
10/01/2024 09/24/2024 Ice Cream House LLC Division of Human and Animal Food Operations East I CGMP/Food/Prepared, Packed or Held Under Unsanitary Conditions/Adulterated/L. monocytogenes
10/01/2024 09/17/2024 Little Moon Essentials, LLC Division of Pharmaceutical Quality Operations II CGMP/Finished Pharmaceuticals/Adulterated
10/01/2024 09/26/2024 Makra Kozmetika D.O.O. Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
10/01/2024 09/26/2024 Supercore Products Group, Inc. Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded
10/01/2024 09/06/2024 Clean Solutions LLC Division of Pharmaceutical Quality Operations I CGMP/Finished Pharmaceuticals/Adulterated
10/02/2024 09/30/2024 Consolidated Trading, Inc., d/b/a Blue Ox Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/08/2024 06/24/2024 JC Finest Produce Inc Division of Southwest Imports Foreign Supplier Verification Program (FSVP)
10/08/2024 09/30/2024 Mexicanrxpharm.com Center for Drug Evaluation and Research (CDER) Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet
10/08/2024 07/11/2024 Green Day Produce, Inc. Division of West Coast Imports Foreign Supplier Verification Program (FSVP)
10/08/2024 09/24/2024 MMC Healthcare Ltd. Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
10/08/2024 09/19/2024 Gorilla Vapes LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/08/2024 09/27/2024 Louisiana State University Health Science Center IRB Center for Drug Evaluation and Research (CDER) Institutional Review Board (IRB)
10/09/2024 10/09/2024 Blaze USA, LLC, d/b/a Blaze Wholesale Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/15/2024 08/30/2024 Procesadora Marina De La Costa Oriental Del Lago C.A. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated
10/15/2024 09/25/2024 Outin Futures Corp. Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
10/15/2024 10/08/2024 Hemarus LLC Center for Biologics Evaluation and Research (CBER) CGMP/Blood & Blood Components/Adulterated
10/15/2024 09/24/2024 Ya Ya Foods USA, LLC Division of Human and Animal Food Operations West IV Low Acid Canned Food Regulation/Adulterated
10/15/2024 09/11/2024 Alfred Louie, Inc. Division of Human and Animal Food Operations West V CGMP/Food/Prepared, Packed or Held Under Unsanitary Conditions/Adulterated
10/15/2024 09/30/2024 Bacalao Giraldo, S.L.U. Center for Food Safety and Applied Nutrition Seafood HACCP/CGMP for Foods/Adulterated
10/15/2024 09/25/2024 Bernardo Farms, LLC Center for Food Safety and Applied Nutrition Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption/Food/Prepared, Packed or Held Under Unsanitary Conditions/Adulterated
10/22/2024 10/10/2024 Namita A. Goyal, M.D. Center for Biologics Evaluation and Research (CBER) Clinical Investigator
10/22/2024 10/09/2024 Central Vapors and Central Vapors LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/22/2024 10/11/2024 Blackfly Investments, LLC dba Molecular® Testing Labs Center for Biologics Evaluation and Research (CBER) Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)
10/22/2024 10/10/2024 Soliteint Kozmetikai KFT Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
10/22/2024 10/01/2024 Pinnacle Transplant Technologies, LLC Center for Biologics Evaluation and Research (CBER) Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
10/22/2024 10/09/2024 OKC Vapes, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/22/2024 10/02/2024 Omni Lens Pvt. Ltd. Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated/Misbranded/Failure to Register
10/22/2024 10/17/2024 Diora Kimya Sanayi ve Ticaret Limited Sirketi Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated/Misbranded/Failure to Register
10/22/2024 10/01/2024 Amnio Technology, LLC Center for Biologics Evaluation and Research (CBER) Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
10/22/2024 10/09/2024 Tasty Cloud Vape Co., LLC d/b/a Tasty Cloud Vape Co. Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/22/2024 04/02/2024 Stokes Healthcare Inc. dba Epicur Pharma Division of Pharmaceutical Quality Operations I Compounding Pharmacy/Adulterated Drug Products
10/29/2024 10/10/2024 Future Best Trading Inc. Division of West Coast Imports Foreign Supplier Verification Program (FSVP)
10/29/2024 10/21/2024 Choice All Natural, Inc. dba Om Botanical Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
10/29/2024 10/23/2024 MedOffice Saglik Endustri Anonim Sirketi Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
10/29/2024 10/01/2024 Paso Real Produce LLC Division of Southwest Imports Foreign Supplier Verification Program (FSVP)
10/30/2024 10/29/2024 North Disposable Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/30/2024 10/30/2024 BFL Metal Products Co., LTD Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/30/2024 10/29/2024 CSVAPE.COM LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/30/2024 10/29/2024 eCig Distributors, Inc. d/b/a eJuices.com Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/30/2024 10/29/2024 Vapes and Such Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/30/2024 10/29/2024 Morevaping Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/30/2024 10/29/2024 Nexus Smoke Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/30/2024 10/29/2024 Green Rush, LLC d/b/a XHALE CITY Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/30/2024 10/29/2024 Packs Pod Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/30/2024 10/29/2024 Funny Vapes Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/31/2024 10/24/2024 Modern Smoking Solutions, LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
10/31/2024 10/31/2024 Liquid Nics LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded