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  3. Compliance Actions and Activities
  4. Warning Letters
  1. Compliance Actions and Activities

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.

 


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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
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