Warning letterPosted August 19, 2025
FDA warning letter to Boothwyn Pharmacy LLC
Unapproved New Animal Drug/Adulterated/Misbranded
FDA posted a warning letter to Boothwyn Pharmacy LLC on August 19, 2025; the letter is dated June 9, 2025. Subject: Unapproved New Animal Drug/Adulterated/Misbranded. Issuing office: Center for Veterinary Medicine.
On the record
- Company
- Boothwyn Pharmacy LLC
- Subject
- Unapproved New Animal Drug/Adulterated/Misbranded
- Issuing office
- Center for Veterinary Medicine
- Letter dated
- 2025-06-09
- Posted by FDA
- 2025-08-19
- Source
- FDA warning letters ↗
CFR cited
The record cites 6 sections of 21 CFR Parts 210, 211 and 530.
The full record
An account shows the violations FDA described and each CFR section it cited.
What a warning letter is
A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.
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