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 |
|---|---|---|---|---|---|---|---|
| Empower Clinic Services, LLC dba Empower Pharmacy | Center for Drug Evaluation and Research (CDER) | Compounding Pharmacy/Adulterated Drug Products | … Empower Clinic Services, LLC dba Empower Pharmacy … WARNING LETTER WL # 700964 April … | ||||
| Empower Clinic Services, LLC dba Empower Pharma | Center for Drug Evaluation and Research (CDER) | Compounding Pharmacy/Adulterated Drug Products | … Empower Clinic Services, LLC dba Empower Pharma … WARNING LETTER WL # 700962 April 2, … | ||||
| Empower Clinic Services, LLC dba Empower Pharmacy | Office of Pharmaceutical Quality Operations, Division II | Compounding Pharmacy/Adulterated Drug Products | … Empower Clinic Services, LLC dba Empower Pharmacy … October 15, 2021 Case #: 613792 … |