FDA 483 - General Air Service & Supply Co., Inc. - March 25, 2022

General Air Service & Supply Co., Inc. in Commerce City, CO, was inspected and cited for multiple significant deficiencies in its quality control and manufacturing processes for medical gases. Key issues include failure to follow written procedures for product release and deviation management, inadequate instrument calibration, poor computer system controls, and undocumented complaint handling. The firm also failed to conduct proper annual record reviews and could not locate past review documentation.