483
Airgas USA LLCFDA 483 - Airgas USA LLC - October 25, 2019
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An FDA inspection of Airgas USA LLC, a medical gas manufacturer in South Salt Lake, UT, revealed a repeat observation regarding the lack of written procedures for production and process controls. Specifically, the firm had not validated its Medical Air USP manufacturing process or assessed equipment changes, indicating significant deficiencies in quality assurance.
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ID · 5344a1f1-8d4f-4dc7-8f98-1ca71f068edc