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 |
|---|---|---|---|---|---|---|---|
| Granules India Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| TKTX USA | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | |||||
| TKTX Store | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | |||||
| Mariscos Procesados - CAMPRESA - S.A. | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated | |||||
| TKTX Numbing Cream USA | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | |||||
| Chem-Tech, Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| TKTX Numb Store | Center for Drug Evaluation and Research (CDER) | Unapproved New Drug and Misbranded |
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| Elk River Vapor Shop | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| The Vapor Club LLC | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Sperm Bank, Inc. dba Fertility Center of California | Center for Biologics Evaluation and Research (CBER) | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |