483
Airgas USA LLCAirgas USA LLC – FDA 483, Oct 25, 2019
Record Details
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
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