Airgas USA LLC – FDA 483, Jul 24, 2026

Airgas, USA, LLC in Baltimore, MD, was cited with three observations during an FDA inspection for significant lapses in quality control and documentation practices for medical gas drug products. The firm failed to adequately investigate recurring in-process failures, lacked detailed procedures for Quality Control Unit responsibilities and documentation system transitions, and did not contemporaneously document all significant manufacturing steps in batch records. These issues reflect a serious lack of oversight and control over critical manufacturing and quality processes.