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 |
---|---|---|---|---|---|---|---|
Top Health Manufacturing, LLC | Division of Human and Animal Food Operations West IV | CGMP/Dietary Supplement/Adulterated | |||||
Armstrong County Memorial Hospital | Center for Drug Evaluation and Research (CDER) | Institutional Review Board (IRB) | |||||
Fancy Drops Beauty LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | |||||
Analytical Food Laboratories, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
Ardent Animal Health, LLC | Center for Veterinary Medicine | Unapproved New Animal Drug Products | |||||
Modern Smoking Solutions, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Liquid Nics LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Nexus Smoke | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
eCig Distributors, Inc. d/b/a eJuices.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Morevaping | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |