FDA EIR - AMPAC Fine Chemicals, LLC dba AMPAC Analytical - October 17, 2018

An FDA surveillance inspection of AMPAC Fine Chemicals, LLC dba AMPAC Analytical, an El Dorado Hills, CA-based control testing laboratory, took place on October 16-17, 2018. This comprehensive cGMP inspection, conducted per CPGM 7356.002 for drug manufacturing and focusing on laboratory chemical/physical testing, was the facility's first. While no FDA Form 483 (Inspectional Observations) was issued, several deficiencies were discussed with management.

Key issues included improper logging of samples upon receipt, failure to maintain stability chamber air filters according to manufacturer recommendations, and unlocked stability chamber user interfaces. Additionally, inconsistencies in equipment verification procedures for GMP and R&D samples, inadequate documentation for laboratory equipment functional checks, and insufficient electronic data audit trail review practices, such as not locking outdated folders, were noted. Management also needed to ensure proper review of equipment usage logs.

AMPAC Analytical's management committed to implementing corrections for these identified discussion items. The verification of these promised corrective actions is slated for review during the subsequent FDA inspection.