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 |
|---|---|---|---|---|---|---|---|
| Sourav K. Mishra, M.D. / All India Institute of Medical Sciences | Center for Drug Evaluation and Research (CDER) | In Vivo Bioavailability-Bioequivalence Studies – Clinical | |||||
| waterbedsnstuff.com | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Great One Trading Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | |||||
| Harbin Jixianglong Biotech Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/API/Adulterated and Misbranded Drugs | |||||
| JW Nutritional LLC | Center for Drug Evaluation and Research (CDER) | CGMP/OTC Finished Pharmaceuticals/Adulterated | |||||
| Hangzhou Yiqi Biotechnology Co., Ltd | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | |||||
| PolleyMed, LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |
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| Naseem A. Jaffrani, M.D. | Center for Drug Evaluation and Research (CDER) | Clinical Investigator | |||||
| Lus Essentials LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | |||||
| La Crema De Rebeca | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded |