# FDA 483 - Airgas USA, LLC - February 23, 2024

Source: https://www.globalkeysolutions.net/records/483/airgas-usa-llc/7caa6a2f-38ab-4246-a392-ac5d13ae63bd

> FDA 483 for Airgas USA, LLC on February 23, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Airgas USA, LLC
- Inspection Date: 2024-02-23
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Airgas USA, LLC, a medical gas manufacturer and distributor in Cheektowaga, NY, received a Form 483 with five observations. The inspection revealed significant deficiencies in equipment qualification and calibration, labeling control, batch record completeness, and the absence of an annual product review program. These issues indicate a lack of robust quality system controls for medical gas production.

## Related Officers

- [Drug Investigator](https://www.globalkeysolutions.net/people/syeda-n-mahazabin/54af6f8a-6d41-4399-b58e-a2d88fd2d7bf)

Company: https://www.globalkeysolutions.net/companies/airgas-usa-llc/32e1453e-0a92-416b-a3c8-88e3b840c2e0

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961