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 |
|---|---|---|---|---|---|---|---|
| Singing Hawk LLC d/b/a Sin City Vapor III | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| The Elderberry Fairy & Co., LLC | Office of Human and Animal Food Operations East Division 6 | Unapproved New Drugs/Misbranded | |||||
| Gordon Laboratories Inc. | Division of Pharmaceutical Quality Operations IV | Drug Product/Adulterated | |||||
| Green Wave Analytical, LLC | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| First Strike Pet Products | Center for Veterinary Medicine | Unapproved New Animal Drug Products | |||||
| Vapor Invasion LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| USA Medical LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | |||||
| Good Guy Vapes Lab LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Nutritional Laboratories International, Inc. DBA Elite One Source Nutritional Services, Inc. | Office of Human and Animal Food Operations – West Division 6 | CGMP/Dietary Supplement/Adulterated/Misbranded |
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| KA Vapes, LLC d/b/a Kickin’ Ash | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |