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

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.