FDA 483 - Airgas USA LLC - February 13, 2026
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Airgas USA, LLC in Orlando, FL, a medical gas manufacturer, was cited for multiple quality system deficiencies during an FDA inspection. Observations included outdated procedures and training regarding current medical gas regulations, and a failure to ensure personnel were adequately trained for product release. Further issues involved incomplete annual product reviews, inadequate instrument calibration, insufficient laboratory record review, and poor facility maintenance in a critical control room.
ID · 66318ce7-9f84-4f5e-a840-d55a7ec7c487