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.
| Posted Date | Letter Issue Date | Company Name | Issuing Office | Subject | Response Letter | Closeout Letter | Excerpt |
|---|---|---|---|---|---|---|---|
| Glenmark Pharmaceuticals Limited | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Saffron USA LLC | Division of Human and Animal Food Operations East IV | Unapproved New Drugs/Misbranded |
|||||
| Cryos International USA LLC | Division of Biological Products Operations I | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | |||||
| Zuland Distributor Corp | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Manzela USA, LLC | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Maliba African Market Corp. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Kari Gran Inc. | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| AG Hair Limited | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Vapor Candy Inc d/b/a The Vape Stop | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Jayde's Vapor Lounge | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |