AIRGAS USA, LLC – FDA 483, Mar 11, 2022

An FDA inspection of AIRGAS USA, LLC's medical gas facility in San Diego, CA, identified critical deficiencies in quality control, labeling, and batch record management. The firm failed to fully investigate errors, maintain strict control over labeling, and ensure complete batch production records. These issues, coupled with unqualified equipment, indicate a lack of adherence to established procedures and overall control.