FDA 483 - Airgas USA, LLC - January 12, 2024

An FDA inspection of Airgas USA, LLC in Salem, NH, from January 8-12, 2024, revealed significant data integrity concerns related to computer system controls. The firm failed to ensure unique usernames for analysts performing gas chromatography testing of medical gases and did not review audit trails, making it impossible to trace test results to specific users. These issues indicate a lack of appropriate controls over critical data.