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 |
|---|---|---|---|---|---|---|---|
| Sichuan Deebio Pharmaceutical Co. Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | |||||
| Salvacion USA Inc. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded |
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| Vixen Vapors LLC d/b/a Vixen Vapors Pantego | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Battle Creek Co-op/CHS, LLC dba Progressive Nutrition | Division of Human and Animal Food Operations West II | CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food for Animals (PCAF)/Adulterated |
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| QuVa Pharma, Inc. | Division of Pharmaceutical Quality Operations I | Compounding Pharmacy/Adulterated Drug Products | |||||
| Global Life Technologies Corp. | Center for Drug Evaluation and Research | CDER | Unapproved New Drugs/Misbranded | |||||
| US Chem Labs | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Ningbo Poplar Daily-Use | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
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| Barkey GmbH & Co. KG | Center for Biologics Evaluation and Research (CBER) | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | |||||
| Madhu Instruments Private Limited | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |