FDA 483 - AIRGAS USA, LLC. - November 04, 2021

From November 1-4, 2021, the FDA inspected Airgas USA, LLC., a medical gas manufacturer located at 7248 SW 29th St, Oklahoma City, OK 73179-5212. The inspection resulted in three observations related to quality and laboratory systems.

Observation 1 noted a failure to thoroughly review unexplained discrepancies. Specifically, the firm did not investigate out-of-maintenance tolerance values recorded during calibration of oxygen analyzer AI-15 on August 9, 2021, and September 12, 2021. The recorded differences for "span maint tolerance" (0.77 and -0.28) and "zero maint tolerance" (0.691 and -0.003) exceeded the procedure's stated maintenance tolerance of (b)(4)%, violating Procedure Number OKCAW-302, Oklahoma City ASU (b)(4) Analyzer Calibration, revision 0.

Observation 2 indicated that employees lacked required training. The Plant Manager was unaware of the requirements for (b)(4) testing and trending of bulk drug products, including Liquid Oxygen USP (LOX) and Liquid Nitrogen NF (LIN), as per Procedure DP 5.4.2 (b)(4) Product Testing of LIN, LOX, LAR and LH2, revision 1. The firm lacked documentation of specific training for this