Boothwyn Pharmacy, LLC
FDA issued a warning letter to Boothwyn Pharmacy, LLC (Kennett Square, PA) following a May–June 2025 inspection that revealed serious deficiencies in sterile compounding practices. The pharmacy distributed GLP-1 injectable products (Semaglutide, Tirzepatide) and other sterile preparations that failed sterility testing and were subpotent relative to their labeled strengths, rendering them adulterated and misbranded under the FDCA. The firm had already initiated a voluntary recall and ceased GLP-1 sterile production, but FDA found corrective action responses inadequate due to missing documentation and contradictory SOPs for at-risk product release. FDA demands a written response within 15 working days and warns that failure to correct violations may result in seizure or injunction.
Flagged claims (3)
If risk release is authorized by patient or prescriber, the Lab pharmacist may retrieve the products required for that specific RX from the designated hold area.
Updated smoke studies will clearly demonstrate that ISO 5 air is not compromised by air entering from the surrounding ISO 7 zone, using improved camera positioning and multiple angles to ensure complete visibility of the airflow boundary.
Any OOS results must be immediately reported to quality and the pharmacist-in-charge. Investigation and root cause analysis should be performed when applicable per SOP QA.CAPA.016.001 Variance and OOS Investigations. A recall and customer notification procedures shall be followed when applicable.
Required actions (3)
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.
Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most pharmacy / compounding sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker