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 |
|---|---|---|---|---|---|---|---|
| You Suck Vapes | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Sabra Dipping Company, LLC | Division of Human and Animal Food Operations East II | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | |||||
| Vape Craft Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| VitaStik, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | |||||
| VitaCig, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
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| NV Nutrition, LLC | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | |||||
| Vitamin Vape, Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
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| Induction Therapies, LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | |||||
| Golden Medal Mushroom Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Synaptent, LLC | Office of Human and Animal Food Operations-East 6 | New Drug/Misbranded |