# FDA 483 - AIRGAS USA, LLC - March 11, 2022

Source: https://www.keypedia.com/records/483/airgas-usa-llc/43d9ec4e-0ec6-4ef7-a57d-d73caa00b199

> FDA 483 for AIRGAS USA, LLC on March 11, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AIRGAS USA, LLC
- Inspection Date: 2022-03-11
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of AIRGAS USA, LLC's medical gas facility in San Diego, CA, identified critical deficiencies in quality control, labeling, and batch record management. The firm failed to fully investigate errors, maintain strict control over labeling, and ensure complete batch production records. These issues, coupled with unqualified equipment, indicate a lack of adherence to established procedures and overall control.

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Company: https://www.keypedia.com/companies/airgas-usa-llc/cd01d692-6058-4ce2-ae8c-16e56b9dd38a

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6