FDA 483 - Airgas USA, LLC - May 30, 2019

An FDA inspection of Airgas USA, LLC in Elmira, NY, a medical gas manufacturer, identified one significant observation. The firm failed to follow its written procedures for conducting annual evaluations of batch records, product complaints, and investigations for OTC drug products, including Oxygen, USP and Nitrogen, NF. This indicates a lapse in quality system adherence regarding record review processes.