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 |
|---|---|---|---|---|---|---|---|
| Center for Instrumental Analysis of China Pharmaceutical University | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | |||||
| Imperial Palace Commodity -Dongguan- Co., Ltd. | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| BioStem Life Sciences | Center for Biologics Evaluation and Research (CBER) | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | |||||
| Fagron Compounding Services, LLC dba Fagron Sterile Service | Center for Drug Evaluation and Research (CDER) | Compounding Pharmacy/Adulterated Drug Products | |||||
| Global Calcium Pvt. Limited | Center for Drug Evaluation and Research (CDER) | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | |||||
| Shantou Kangjie Daily Chemical Industry Co., Ltd | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Talla Imports, LLC | Office of Inspections and Investigations | Foreign Supplier Verification Program (FSVP) | |||||
| Mihon Corp. d/b/a VitalityVita and Boulla, LLC | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs/Misbranded | |||||
| Chara Biologics, Inc. | Center for Biologics Evaluation and Research (CBER) | CGMP/Deviations/Biologics License Application (BLA) | |||||
| Americo F. Padilla, M.D./Miami Dade Medical Research Institute | Center for Drug Evaluation and Research (CDER) | Clinical Investigator |