# FDA 483 - AIRGAS USA, LLC - July 27, 2023

Source: https://www.keypedia.com/records/483/airgas-usa-llc/f9d8cc58-59af-4867-a12e-303828eded63

> FDA 483 for AIRGAS USA, LLC on July 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AIRGAS USA, LLC
- Inspection Date: 2023-07-27
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of AIRGAS USA, LLC in Linthicum Heights, MD, a medical gas manufacturer, revealed two significant observations. The firm failed to properly qualify critical equipment used in medical gas production and did not adequately investigate and implement corrective actions for consumer complaints regarding malfunctioning cylinder valves, which have been ongoing since 2013. These issues indicate deficiencies in equipment management and quality system processes.

## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.keypedia.com/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)

Company: https://www.keypedia.com/companies/airgas-usa-llc/277e7b93-1aa3-41a8-b33d-9b2188a44747

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64