FDA EIR - AMPAC Fine Chemicals LLC - January 31, 2019

A U.S. Food and Drug Administration (FDA) inspection of AMPAC Fine Chemicals, LLC (AFC) in Rancho Cordova, CA, occurred from January 22-31, 2019. This was a comprehensive Current Good Manufacturing Practice (cGMP) inspection for Active Pharmaceutical Ingredient (API) manufacturers, conducted under Compliance Program 7356.002F and guided by ICH Q7 standards, focusing on non-sterile APIs by chemical synthesis. Crucially, no FDA Form 483, Inspectional Observations, was issued, classifying the inspection as "No Action Indicated" (NAI). However, during the closeout meeting, several key areas for improvement were discussed with management. These included the need to implement a comprehensive site review for all APIs and intermediates, ensure comprehensive summaries accompany significant post-investigational activities, and conduct a study to justify hard-to-clean equipment areas, necessitating a revision of the Equipment Cleaning and Use Procedure (AFC-SOP-0017). Additionally, instructions for performing and justifying effectiveness checks related to Corrective and Preventative Actions (CAPA) (AFC-SOP-0026) required definition. Management, represented by Vice President Regulatory Affairs, Jeff Robinson, acknowledged these discussion items and committed to documenting voluntary corrective actions within the firm's CAPA program. While no formal violations were cited, these discussions highlight the agency's expectations for continuous improvement in quality systems and documentation practices.