FDA EIR - Alliance Medical Products, Inc. DBA Siegfried Company - August 13, 2013

An FDA inspection of Alliance Medical Products, Inc. in Irvine, CA, conducted from July 10 to August 16, 2013, uncovered significant deficiencies in the company's manufacturing and quality control operations, indicating non-compliance with Good Manufacturing Practices. Key findings included incomplete reporting of rejected product lots in Annual Product Reviews and multiple batch rejections due to issues like inconsistent fill volumes, environmental monitoring system failures, and inadequate crimp seal integrity. The inspection also revealed product stability failures, with impurities exceeding specifications and analytical methods not being stability-indicating. Systemic validation problems were identified in laboratory methods, computer systems, and manufacturing processes. The facility's environmental controls were suboptimal, including unmonitored nonviable particulates in cleanrooms and the Water for Injection system failing bioburden specifications. Critical equipment, such as balances and pressure gauges, lacked proper calibration, and raw material controls were insufficient, with supplier certificates accepted without verification. Laboratory operations showed a lack of accountability, deficient calibration of analytical instruments, improper management of reference standards, and failure to adhere to established testing procedures and documentation standards. These observations necessitate a thorough review and implementation of corrective actions to ensure product quality and regulatory compliance.