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 | … Boothwyn Pharmacy, LLC … WARNING LETTER WL # 717525 January 16, 2026 Dear Mr. … (FDA) investigators inspected your facility, Boothwyn Pharmacy, LLC, located at 221 Gale Lane, Kennett … | ||||
| Boothwyn Pharmacy LLC | Center for Veterinary Medicine | Unapproved New Animal Drug/Adulterated/Misbranded | … Boothwyn Pharmacy LLC … June 9, 2025 WARNING LETTER Reference Case: 710247 Dear … and Drug Administration (FDA) inspected your facility, Boothwyn Pharmacy, located at 221 Gale Lane, Kennett Square, … |