FDA 483 - AIRGAS USA, LLC - July 27, 2023

An FDA inspection of AIRGAS USA, LLC in Linthicum Heights, MD, a medical gas manufacturer, revealed two significant observations. The firm failed to properly qualify critical equipment used in medical gas production and did not adequately investigate and implement corrective actions for consumer complaints regarding malfunctioning cylinder valves, which have been ongoing since 2013. These issues indicate deficiencies in equipment management and quality system processes.