FDA 483 - Airgas USA, LLC - March 02, 2021
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An FDA inspection of Airgas USA, LLC in Fort Collins, CO, a medical gas transfiller, identified four significant deficiencies. These included the distribution of medical oxygen without proper quality control review, inadequate employee training on cGMP procedures, and a lack of continuing GMP training documentation. Additionally, the firm failed to provide documentation for the routine calibration of scales used in the production of liquid medical oxygen and nitrogen.
ID · 18915352-58bc-4b2b-a2e3-03c0034066bd