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 |
|---|---|---|---|---|---|---|---|
| Appleton City Feed Service LLC | Division of Human and Animal Food Operations West II | CGMP/Medicated Feeds/Adulterated | |||||
| Master Paints & Chemicals Corp. | Division of Pharmaceutical Quality Operations II | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Natco Pharma Limited | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Euro USA Inc | Division of Human and Animal Food Operations East V | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | |||||
| EPD International S.R.O. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Kai’s Virgin Vapor | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| La Sucursal Produce Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Soulaire Corporation | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | |||||
| Lipari Foods Operating Company, LLC | Division of Human and Animal Food Operations East VI | Food Labeling/Misbranded |
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| C&T Dream Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |