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.
- Frequently requested records may be accessed on the Reading Room page.
| Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter | Excerpt |
|---|---|---|---|---|---|---|---|
| Excelvision - Fareva | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Wizcure Pharmaa Private Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| 3B Medical, Inc. dba Reach Health, Inc. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated | |||||
| BMC Medical Co., Ltd. | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded |
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| Genzyme Ireland Limited | Center for Biologics Evaluation and Research (CBER) | CGMP/Deviations/Biologics License Application (BLA) | |||||
| Golden Dakota Farms LLC | Center for Veterinary Medicine | New Animal Drug/Adulterated | |||||
| AseptiKits, LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
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| Yangzhou Hongshengding Chemical Co., Ltd. | Center for Drug Evaluation and Research (CDER) | Refusal to Provide Access to and Copying of Records | |||||
| Flax & More Corporation | Human Foods Program | CGMP/Dietary Supplement/Adulterated |
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| Life & Food Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |