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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
Consolidated Trading, Inc., d/b/a Blue Ox Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Ice Cream House LLC Division of Human and Animal Food Operations East I CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
Makra Kozmetika D.O.O. Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
Far East Summit LLC Division of Human and Animal Food Operations West VI Unapproved New Drugs/Misbranded
Pacific Exchange Distributors LLC Division of West Coast Imports Foreign Supplier Verification Program (FSVP)
NRS Enterprises, Inc. d/b/a Sunflour Bakery Division of Human and Animal Food Operations West V CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Shake Hemp Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Clean Solutions LLC Division of Pharmaceutical Quality Operations I CGMP/Finished Pharmaceuticals/Adulterated
Little Moon Essentials, LLC Division of Pharmaceutical Quality Operations II CGMP/Finished Pharmaceuticals/Adulterated
Supercore Products Group, Inc. Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded
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