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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
Blaze USA, LLC, d/b/a Blaze Wholesale Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
JC Finest Produce Inc Division of Southwest Imports Foreign Supplier Verification Program (FSVP)
MMC Healthcare Ltd. Center for Drug Evaluation and Research (CDER) CGMP/Finished Pharmaceuticals/Adulterated
Gorilla Vapes LLC Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
Louisiana State University Health Science Center IRB Center for Drug Evaluation and Research (CDER) Institutional Review Board (IRB)
Mexicanrxpharm.com Center for Drug Evaluation and Research (CDER) Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet
Green Day Produce, Inc. Division of West Coast Imports Foreign Supplier Verification Program (FSVP)
Consolidated Trading, Inc., d/b/a Blue Ox Vapor Center for Tobacco Products Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
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
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