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.
Showing 1 to 10 of 3,186 entries
Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter | Excerpt |
---|---|---|---|---|---|---|---|
Tyche Industries Ltd | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
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Jagsonpal Pharmaceuticals Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceutical/Adulterated | |||||
AmWiner & Raphe Holdings, LLC dba rapheGenerics Corp | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
ABR Laboratory LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceutical/Adulterated | |||||
Zenzi Pharmaceutical Industries Pvt. Ltd. | Center for Drug Evaluation and Research (CDER) | Refusal to Provide Access to and Copying of Records | |||||
Steep Slope Vape Supply | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Route 66 Vapor | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Walker Enterprises, LLC d/b/a MaddCatt Vapor | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
A-Z Tobacco Inc d/b/a A-Z Tobacco and Vapor | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
Smoke and Vape Inc d/b/a Backdoor Smoke Shop | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
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