FDA 483 - Greene Respiratory Services, Inc. - March 31, 2023

An FDA inspection of Greene Respiratory Services, Inc. in Columbus, OH, a medical gas manufacturer, revealed significant deficiencies in their quality control unit, manufacturing practices, and record-keeping for Oxygen USP. The firm lacked a designated quality control unit, written procedures for critical operations, and proper employee training in current good manufacturing practices. These findings indicate a serious lack of adherence to regulatory requirements for drug product manufacturing.