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 |
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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 |
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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) |
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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 |