FDA 483 - Alliance Medical Products, Inc. DBA Siegfried Company - November 07, 2025

Alliance Medical Products, Inc. in Irvine, CA, a contract drug manufacturer, received a Form 483 for significant deficiencies in its manufacturing and quality systems. The inspection revealed inadequate aseptic process validation, including media fill simulations and smoke studies, and issues with cleaning and disinfection procedures for aseptic areas. Additionally, the firm's laboratory controls for finished product quality testing and its consumer complaint investigation processes were found to be insufficient.