Alliance Medical Products, Inc. DBA Siegfried Company – FDA 483, May 21, 2021

An FDA inspection of Alliance Medical Products, Inc. DBA Siegfried Company in Irvine, CA, a sterile drug manufacturer, revealed significant deficiencies across four observations. The firm failed to maintain adequate records for equipment monitoring, including missing temperature data and numerous unaddressed alarms. Additionally, the quality control unit's procedures were not consistently followed or adequately documented, leading to issues with aseptic processing, investigations, and equipment maintenance. The firm also failed to thoroughly investigate out-of-specification bioburden results and endotoxin testing suitability failures, and environmental monitoring in aseptic areas was found to be deficient.