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 |
|---|---|---|---|---|---|---|---|
| Laboratorios Jaloma S.A. de C.V. | Center for Drug Evaluation and Research (CDER) | CGMP/OTC/Finished Pharmaceuticals/Adulterated | |||||
| Aeroflex Industria de Aerosol Ltda. | Center for Drug Evaluation and Research (CDER) | Refusal to Provide Access to and Copying of Records |
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| Meta Labs Pharmaceuticals, LLC | Human Foods Program | Dietary Supplement/New Drug/Misbranded | |||||
| HealthPartners Neuroscience Center Research and Innovation | Center for Drug Evaluation and Research (CDER) | Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies | |||||
| City Market, Inc. | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | |||||
| Boba Factory Inc | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) |
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| Stavis Seafoods, LLC | Office of Inspections and Investigations | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | |||||
| Dough-To-Go, Inc. | Human Foods Program | CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated | |||||
| Aversa's Italian Bakery | Human Foods Program | CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated | |||||
| Medline Inc | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated |