FDA 483 - Airgas USA, LLC - February 23, 2024

Airgas USA, LLC, a medical gas manufacturer and distributor in Cheektowaga, NY, received a Form 483 with five observations. The inspection revealed significant deficiencies in equipment qualification and calibration, labeling control, batch record completeness, and the absence of an annual product review program. These issues indicate a lack of robust quality system controls for medical gas production.