483
Airgas USA LLCAirgas USA LLC – FDA 483, Feb 13, 2026
Record Details
Airgas USA, LLC in Orlando, FL, a medical gas manufacturer, received an FDA Form 483 citing significant quality system deficiencies. The firm failed to update procedures and training to current medical gas regulations, leading to unqualified personnel releasing products. Additional issues included incomplete annual product reviews, inadequate instrument calibration practices, and a critical control room with damaged ceiling tiles and water stains.
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ID · 0a8ac515-6657-4cfb-9b64-725a3cb894ad
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