# FDA 483 - AIRGAS USA, LLC. - November 04, 2021

Source: https://www.keypedia.com/records/483/airgas-usa-llc/e5c5b44b-6f28-4bbf-b8c4-2ee2ccae0dc6

> FDA 483 for AIRGAS USA, LLC. on November 04, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AIRGAS USA, LLC.
- Inspection Date: 2021-11-04
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of AIRGAS USA, LLC. in Oklahoma City, OK, a medical gas manufacturer, revealed significant deficiencies in quality system controls. The firm failed to thoroughly investigate out-of-tolerance calibration discrepancies, and employees, including the Plant Manager, lacked required training for critical product testing procedures. Additionally, established sampling plans and test procedures for bulk drug products were not followed.

## Related Documents

- [483 - 2021-11-04](https://www.keypedia.com/records/483/airgas-usa-llc/5534a7d8-ef3e-4b8c-83c9-d8abeac4b5cc)
- [483 - 2021-11-04](https://www.keypedia.com/records/483/airgas-usa-llc/a8c5c814-209f-4e25-8d49-066937a1d791)

## Related Officers

- [Investigator](https://www.keypedia.com/people/preston-b-hoover/0f805e3f-63f2-4d2d-aeb2-4f6287cfec86)
- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

Company: https://www.keypedia.com/companies/airgas-usa-llc/4b907eaf-4756-4ab5-96df-9b7680cb8344

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab