# FDA 483 - Airgas USA, LLC - October 18, 2019

Source: https://www.globalkeysolutions.net/records/483/airgas-usa-llc/8b196a14-27d6-4a3a-82f0-f32d08632b91

> FDA 483 for Airgas USA, LLC on October 18, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Airgas USA, LLC
- Inspection Date: 2019-10-18
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Airgas USA, LLC in Miami, FL, a manufacturer of compressed medical gas, received a Form 483 with five observations related to inadequate controls and documentation during the manufacturing and testing of drug products. The inspection revealed issues with equipment location, laboratory testing procedures, master and batch production records, and quality control unit responsibilities. These deficiencies indicate potential contamination risks and a lack of assurance in product quality and control.

## Related Documents

- [483 - 2022-07-22](https://www.globalkeysolutions.net/records/483/airgas-usa-llc/b27a71d8-fb94-4505-9781-511aa4f149b2)

## Related Officers

- [Vivin George](https://www.globalkeysolutions.net/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)
- [Special Assistant](https://www.globalkeysolutions.net/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)

Company: https://www.globalkeysolutions.net/companies/airgas-usa-llc/54385888-293d-453c-bb90-38e772b1964f

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6