FDA EIR - Airgas USA, LLC - January 26, 2017

An FDA inspection of Airgas USA, LLC, a distributor and transfiller of compressed medical oxygen, industrial, and food grade gases located in Pueblo, CO, was conducted from January 24-26, 2017. The inspection, carried out under Compliance Program 7356.002E for Compressed Medical Gases, identified one significant observation. A Form FDA-483 was issued to the Branch Manager concerning the utilization of a liquid leak detector containing Glycol, a hazardous substance, during medical oxygen transfilling operations. The firm lacked documentation demonstrating that this solution did not contaminate the finished drug product. Furthermore, there was no written standard operating procedure or employee training specifically addressing the leak detection process. This issue relates to drug product container/closure integrity under 21 CFR 211.94(a), which requires that they not alter the safety, identity, strength, quality, and purity of the drug. Additionally, management was advised about an open dock door in the warehouse, which was promptly closed as a voluntary correction. Airgas USA, LLC is required to submit a formal written response to the FDA District within 15 business days addressing the Form FDA-483 observation.