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 |
|---|---|---|---|---|---|---|---|
| Lyons Magnus, LLC | Division of Human and Animal Food Operations West I | Low Acid Canned Food Regulation/Adulterated | |||||
| American Cruise Lines | Division of Human and Animal Food Operations East V | Insanitary Conditions/Adulterated | |||||
| Clean Cosmetics LLC | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Wintech Medipro LLC | Division of Medical Device and Radiological Health Operations West | CGMP/QSR/Medical Devices/PMA/Adulterated |
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| Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Flavor Vapors, LLC/Mob Liquid Labs | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Unlit Vapor Shoppe LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Salon Technologies International, Inc. | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Mark S. Denker, M.D., PA dba Palm Beach Fertility Center | Division of Biological Products Operations I | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | |||||
| Quality Supplement Manufacturing, Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated |