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 |
|---|---|---|---|---|---|---|---|
| Custom Research Labs Inc. | Division of Pharmaceutical Quality Operations IV | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Zhang Medical P.C. dba New Hope Fertility Center | Office of Biological Products Operations – Division 1 | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | |||||
| Bolive, Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) | |||||
| Bi-Coastal Pharma International | Office of Pharmaceutical Quality Operations Division I | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Daniel Fred Goodman, M.D./Goodman Eye Center | Center for Drug Evaluation and Research | CDER | Bioresearch Monitoring Program/Institutional Review Board (IRB) | |||||
| Blackout Vapors Inc. | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| M & K On Cumberland, Inc. dba Big Cloud Vape & Tobacco | Center for Tobacco Products | Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded | |||||
| Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd. | Center for Drug Evaluation and Research | CDER | Refusal to Provide Access to and Copying of Records | |||||
| Jose Miguel Gutierrez Salas | Center for Drug Evaluation and Research | CDER | Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated/Failure to Register and List |
|||||
| Everyday Import & Export, Inc. dba Everyday Group LLC | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |