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 |