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 |
|---|---|---|---|---|---|---|---|
| Lion Street Medical, d/b/a Pensar Medical LLC | Center for Devices and Radiological Health | Medical Device Reporting/Misbranded | |||||
| Specialty Health Products CO, LLC | Center for Devices and Radiological Health | CGMP/QSR/Medical Devices/Adulterated |
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| Advance-Esthetic LLC | Center for Devices and Radiological Health | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device | |||||
| Empower Clinic Services, LLC dba Empower Pharmacy | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug | |||||
| Accra Supermarket | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
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| Shouly Import Corp. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | |||||
| Ohom Padmaavathii, LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | |||||
| Binh Minh Tofu | Human Foods Program | CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated | |||||
| kdc/one Chatsworth, Inc. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| NexCell Scientific Inc | Center for Biologics Evaluation and Research | Unapproved New Drugs/Unlicensed Biological Product Violations |