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|
|Marina Technology LLC||Center for Tobacco Products||Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded|
|Cosmetic Science Laboratories LLC||Division of Pharmaceutical Quality Operations IV||CGMP/Finished Pharmaceuticals/Adulterated|
|Dunagin Pharmaceuticals Inc. dba Massco Dental||Division of Pharmaceutical Quality Operations II||CGMP/Finished Pharmaceuticals/Adulterated|
|Mariscos Bahia, Inc.||Division of Human and Animal Food Operations West V||Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions|
|Herbal Vitality, Inc.||Division of Human and Animal Food Operations West IV||Unapproved New Drugs/Misbranded
|Procter & Gamble Manufactura S. de R.L. de C.V.||Center for Drug Evaluation and Research | CDER||Failure to Register and List|
|J&H Imports Services Corp||Division of Northeast Imports||Foreign Supplier Verification Program (FSVP)|
|Capital Imports LLC||Division of Northern Border Imports||Foreign Supplier Verification Program (FSVP)|
|www.ivermectin4covid.com||Center for Drug Evaluation and Research | CDER||Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet|
|Olympus Medical Systems Corp.||Center for Devices and Radiological Health||CGMP/QSR/Medical Devices/Adulterated/Misbranded|