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 |
---|---|---|---|---|---|---|---|
Sanofi | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | |||||
Atlanta Supersource, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
www.weightcrunchshop.com | Center for Drug Evaluation and Research (CDER) | Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet | |||||
Nyumbani Hakuna Matata LLC | Division of Northern Border Imports | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | |||||
Premium Fresh Growers LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | |||||
Salt City Baking Company, LLC | Human Foods Program | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
INCELL Corporation LLC | Center for Biologics Evaluation and Research (CBER) | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | |||||
Duong Ha Processing Trading Seafood Company Limited | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated | |||||
COFISA - Conservas de Peixe da Figueira, S.A. | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | |||||
Western Innovations, Inc. | Human Foods Program | CGMP/Dietary Supplement/Adulterated |