FDA 483 - Airgas USA LLC - December 16, 2024

Airgas USA LLC, a medical gas transfiller in South Salt Lake, UT, received two observations during an FDA inspection. The firm was cited for not performing routine equipment calibration according to a written program and for failing to have sampling plans for bulk supply gas drafted and approved by the quality control unit. These observations highlight deficiencies in the firm's quality control and procedural adherence for medical gas production.