FDA EIR - Alliance Medical Products, Inc. DBA Siegfried Company - February 14, 2019

An FDA inspection of Alliance Medical Products, Inc. was conducted from February 4 to February 14, 2019. This inspection served as both a current Good Manufacturing Practice (cGMP) and Pre-Approval Inspection (PAI) for the contract manufacturer's sterile human drug operations. The inspection identified significant deficiencies, resulting in an eight-item FDA Form 483. Key issues included multiple failures within laboratory controls, specifically concerning the suitability, scientific soundness, accuracy, and reproducibility of bacterial endotoxin testing methods, as well as incomplete records for laboratory instrument calibrations. Furthermore, the company was cited for inadequate procedures to prevent microbiological contamination of drug products and a lack of validation for growth promotion tests used in environmental monitoring. Repeat observations highlighted ongoing challenges with the quality control unit's adherence to written responsibilities, particularly regarding timely CAPA closure and proper management of production process changes. The firm also failed to adequately record and maintain evidence of reserve drug product deterioration. These observations necessitate prompt and comprehensive corrective actions to ensure full compliance with regulatory standards and safeguard product quality and patient safety.