Warning Letters

Learn about the types of warning letters on FDA's website.

• Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the letter.
• To obtain additional available information, contact FDA. Requests to FDA for agency records should be sent to: Food and Drug Administration Division of Freedom of Information (HFI-35), 5630 Fishers Lane, Rockville, MD 20857. Instructions for how to submit an FOI request can be found at How to Make a FOIA Request.

 

Posted Date	Letter Issue Date	Company Name	Issuing Office	Subject	Response Letter	Closeout Letter	Excerpt
03/23/2023	03/23/2023	Stuff N Puffs 101, LLC d/b/a Stuff-N-Puffs	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
03/21/2023	02/07/2023	Mariscos Bahia, Inc.	Division of Human and Animal Food Operations West V	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
03/21/2023	03/07/2023	Herbal Vitality, Inc.	Division of Human and Animal Food Operations West IV	Unapproved New Drugs/Misbranded
03/21/2023	02/22/2023	Capital Imports LLC	Division of Northern Border Imports	Foreign Supplier Verification Program (FSVP)
03/21/2023	02/22/2023	Dunagin Pharmaceuticals Inc. dba Massco Dental	Division of Pharmaceutical Quality Operations II	CGMP/Finished Pharmaceuticals/Adulterated
03/21/2023	03/10/2023	Cosmetic Science Laboratories LLC	Division of Pharmaceutical Quality Operations IV	CGMP/Finished Pharmaceuticals/Adulterated
03/21/2023	03/16/2023	Marina Technology LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
03/21/2023	03/14/2023	Procter & Gamble Manufactura S. de R.L. de C.V.	Center for Drug Evaluation and Research | CDER	Failure to Register and List
03/21/2023	03/13/2023	J&H Imports Services Corp	Division of Northeast Imports	Foreign Supplier Verification Program (FSVP)
03/21/2023	03/16/2023	www.ivermectin4covid.com	Center for Drug Evaluation and Research | CDER	Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet

Download XLSX

Download XLSX