# FDA 483 - Airgas USA LLC - October 25, 2019

Source: https://www.keypedia.com/records/483/airgas-usa-llc/5344a1f1-8d4f-4dc7-8f98-1ca71f068edc

> FDA 483 for Airgas USA LLC on October 25, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Airgas USA LLC
- Inspection Date: 2019-10-25
- Product Type: drugs
- Office Name: Denver District Office
- Summary: 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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Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face