FDA 483 - AIRGAS USA, LLC. - November 04, 2021

An FDA inspection of AIRGAS USA, LLC. in Oklahoma City, OK, a medical gas manufacturer, revealed significant deficiencies in quality system controls. The firm failed to thoroughly investigate out-of-tolerance calibration discrepancies, and employees, including the Plant Manager, lacked required training for critical product testing procedures. Additionally, established sampling plans and test procedures for bulk drug products were not followed.