Issued to Boothwyn Pharmacy, LLC. Serious post-market compliance violation.
Issued
January 16, 2026Product
Compounding Pharmacy/Adulterated Drug Products
Company
Boothwyn Pharmacy, LLC
Review center
CDERStage
Final Decision
Assyro regulatory brief
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FDA issued a warning letter to Boothwyn Pharmacy, LLC concerning Compounding Pharmacy/Adulterated Drug Products. No controlled compliance theme met the deterministic text-matching threshold; review the exact FDA web letter and any later response or closeout.
Review the exact FDA warning letter, cited violations, requested corrections, and any later response or closeout before assessing current status.
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Serious post-market compliance violation. Public notice requiring prompt remediation. FDA issued this letter on January 16, 2026.
The firm is expected to respond in writing, normally within 15 working days, describing corrective actions and timelines. FDA verifies remediation — often through reinspection — and issues a closeout letter when violations are corrected. Unresolved warning letters can escalate to import alerts, seizure, or injunction.