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 |
|---|---|---|---|---|---|---|---|
| Boothwyn Pharmacy, LLC | Center for Drug Evaluation and Research (CDER) | Compounding Pharmacy/Adulterated Drug Products | |||||
| Signature Formulations, LLC | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| Mark S. Dacey, M.D. | Center for Drug Evaluation and Research (CDER) | Clinical Investigator | |||||
| Maui Seafood LLC | Human Foods Program | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | |||||
| Bio-Medical Pharmaceutical Manufacturing Corporation | Center for Drug Evaluation and Research (CDER) | CGMP/Finished Pharmaceuticals/Adulterated | |||||
| ProDx Health | Center for Biologics Evaluation and Research (CBER) | Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) | |||||
| Conceive Fertility Center | Center for Biologics Evaluation and Research (CBER) | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | |||||
| Central Coast Multispecialty Medical Group, Inc. | Center for Biologics Evaluation and Research (CBER) | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | |||||
| Louisville Reproductive Center | Center for Biologics Evaluation and Research | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) | |||||
| Beach Weekend Management LLC dba Nic and Jet Fuel | Center for Drug Evaluation and Research (CDER) | Unapproved New Drugs |