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

During an inspection conducted from November 1-4, 2021, the U.S. Food and Drug Administration (FDA) issued a Form 483 to AIRGAS USA, LLC., a medical gas manufacturer located in Oklahoma City, OK. The inspection revealed significant concerns regarding the company's quality system and laboratory controls, indicating potential deviations from regulatory expectations for drug product manufacturing.Three main observations were noted. Firstly, the firm failed to adequately investigate unexplained discrepancies, specifically regarding out-of-tolerance calibration values for an oxygen analyzer, despite its own established procedures requiring such investigations. Secondly, personnel, including the Plant Manager, lacked essential training necessary to perform assigned functions, particularly concerning specific product testing and trending requirements for bulk drug products like Liquid Oxygen USP and Liquid Nitrogen NF. Finally, related to the training deficiency, the inspection found that established sampling plans and test procedures for these bulk drug products were not being followed, as critical testing and trending activities were not performed by Quality Assurance due to a lack of awareness and training. These observations highlight the need for AIRGAS USA, LLC. to implement comprehensive corrective actions to ensure proper adherence to quality system requirements, adequate personnel training, and consistent execution of established laboratory and testing procedures for medical gases.