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 |
|---|---|---|---|---|---|---|---|
| Syntec Pharma Corp | Office of Pharmaceutical Quality Operations Division I | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
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| Farmakeio Outsourcing LLC | Office of Pharmaceutical Quality Operations, Division II | Compounding Pharmacy/Adulterated Drug Products | |||||
| 2m Associates, Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Green City Distribution | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Bradley Jaramillo LLC d/b/a Trinity Vapor Lounge | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| The Vapor Hutt | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| MB Solutions, LLC/BioSpectrum CBD | Center for Drug Evaluation and Research | Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products |
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| rxmedkart.com | Center for Drug Evaluation and Research | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) | |||||
| Visible Vapors, LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Sck Zeta Dis Ticaret, Pazarlama Ltd. | Center for Drug Evaluation and Research | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |