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 |
|---|---|---|---|---|---|---|---|
| Linemaster Switch Corporation | Center for Devices and Radiological Health | CGMP/QSR/Drug/Medical Devices/Adulterated | |||||
| Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd. | Center for Drug Evaluation and Research (CDER) | In Vivo Bioavailability-Bioequivalence Studies – Clinical | |||||
| Island Kinetics, Inc. d.b.a. CoValence Laboratories | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated | |||||
| BioMylz Pvt. Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded | |||||
| Almon Healthcare Private Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | |||||
| Shang Hao Jia, Inc. | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | |||||
| Balkanica LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | |||||
| Beauty Store LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | |||||
| IJAJ Group Inc DBA Sanz Wholesale Foods | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | |||||
| mkpodplug.co.uk | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |