AGC Biologics A/S – FDA EIR, Oct 13, 2015

An FDA pre-license inspection was conducted at CMC Biologics A/S in Copenhagen, Denmark, from October 7-13, 2015. This was the first FDA inspection for the facility, and it supported a Biologics License Application (BLA) for drug substance manufacturing. The inspection, led by the Center for Biologics Evaluation and Research (CBER), encompassed a comprehensive audit of quality systems, production systems, facilities, support systems, and laboratory control systems, all within the framework of Good Manufacturing Practices (GMPs) and relevant EU directives.

Key areas reviewed included deviation management, change control, document and record control, batch record review, quality agreements, training programs, and the internal audit system. Importantly, the FDA inspection team did not issue a Form FDA 483, which indicates no observed objectionable conditions or significant regulatory violations. No formal refusals, sample collections, or warnings were given to CMC Biologics management. Although minor discussion points arose concerning the status of expired SOPs and the storage of training plans, these were addressed or deemed unobjectionable during the inspection. As a result of these findings, no specific required actions were formally mandated by the FDA following this pre-license inspection.