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 |
|---|---|---|---|---|---|---|---|
| HotHead Vapor | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| DENTON VAPE SHOPPE | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| E-Cig Mania LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Jon B. Cole, MD | Center for Drug Evaluation and Research | CDER | Failure to obtain Investigational New Drug Applications | |||||
| Lauren R. Klein, MD, M.S. | Center for Drug Evaluation and Research | CDER | Failure to obtain Investigational New Drug Applications | |||||
| AriBio H&B Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | |||||
| The Camel Milk Co. LLC dba Camel Culture | Office of Human and Animal Foods Operations – Division West 4 | New Drug/Misbranded | |||||
| Magnolia Medical Technologies, Inc. | Office of Medical Devices and Radiological Health, Division 3 | CGMP/QSR/Medical Devices/Adulterated | |||||
| Sircle Laboratories, LLC | Office of Pharmaceutical Quality Operations, Division II | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Marcus Research Laboratory, Inc. | Division of Pharmaceutical Quality Operations III | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |