What happened
FDA states that its November 3-14, 2025, inspection found Empower Pharmacy’s compounded semaglutide and tirzepatide products did not meet section 503A conditions, making the ineligible products subject to CGMP. Investigators observed that sterile products were prepared under insanitary conditions. Smoke studies did not adequately demonstrate unidirectional airflow under dynamic conditions, and media fills were not conducted under the most challenging conditions. FDA also cited inadequate maintenance systems for equipment controlling aseptic conditions, deficient procedures to prevent microbiological contamination and validate aseptic and sterilization processes, inadequate environmental monitoring, insufficient production and process-control procedures, and failure of the quality control unit to ensure CGMP compliance and product specifications. In reviewing corrective actions, FDA said a revised smoke study remained unfinalized. It also identified unexplained vial-count discrepancies, missing or unclear media-fill records, undefined “N/A” entries, and transcription of original results onto a revised form without a clear audit trail, authorization, or justification.
Why it matters
These observations may matter because airflow protection, representative media fills, environmental monitoring, equipment maintenance, and validated contamination controls collectively support confidence that sterile products are produced aseptically. FDA specifically linked the smoke-study and media-fill deficiencies to contamination risk and lack of assurance in aseptic production. Incomplete reconciliation of media-fill units and unexplained transcription of results may also weaken traceability and the evidentiary basis for concluding that every vial was inspected and contamination-free. The cited quality-unit and process-control deficiencies further indicate weaknesses in manufacturing oversight and consistency.
Key topics: Inadequate dynamic smoke studies for ISO 5 airflow, Non-challenging media fills with unresolved vial-count discrepancies, Deficient aseptic quality oversight and environmental monitoring