# FDA 483 - Airgas USA, LLC - June 07, 2022

Source: https://www.keypedia.com/records/483/airgas-usa-llc/f6626787-af07-4b61-9b8d-754e06f96563

> FDA 483 for Airgas USA, LLC on June 07, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Airgas USA, LLC
- Inspection Date: 2022-06-07
- Product Type: drugs
- Office Name: Denver District Office
- Summary: An FDA inspection of Airgas USA, LLC in Tucson, AZ, a medical gas facility, revealed significant deficiencies in its quality system. The firm's Quality Control Unit failed to adhere to written procedures for out-of-specification investigations and customer complaint handling, lacking proper documentation for both. Additionally, the inspection found incomplete batch production records regarding labeling and a lack of strict control over batch lot number labels, increasing the risk of mix-ups.

## Related Officers

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Company: https://www.keypedia.com/companies/airgas-usa-llc/4dfa6965-d697-41b3-a149-32f2f9fbc3d6

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face