FDA 483 - Airgas USA, LLC - June 07, 2022

An FDA inspection of Airgas USA, LLC in Tucson, AZ, a medical gas facility, revealed significant deficiencies in its quality system. The firm's Quality Control Unit failed to adhere to written procedures for out-of-specification investigations and customer complaint handling, lacking proper documentation for both. Additionally, the inspection found incomplete batch production records regarding labeling and a lack of strict control over batch lot number labels, increasing the risk of mix-ups.