FDA 483 - Alliance Medical Products, Inc. DBA Siegfried Company - May 26, 2017

An FDA inspection of Alliance Medical Products, Inc. in Irvine, CA, revealed significant deficiencies in their manufacturing operations. The firm failed to adequately validate analytical test methods and computer spreadsheets, properly investigate out-of-specification results, and maintain appropriate environmental controls for stability chambers. Additional issues included inadequate laboratory sampling plans, non-adherence to established procedures, poor material storage, insufficient employee training, and failures in their corrective and preventive action system.