FDA 483 - Mission Systems Davenport Inc. - March 30, 2023

An FDA inspection of Mission Systems Davenport Inc. in Davenport, IA, a medical device manufacturer, identified a significant compliance issue. The firm failed to include unique device identifiers (UDI) or universal product codes (UPC) in the device history record or on the labeling for their Class II AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS) Oxygen Concentrator. This indicates a deficiency in their device labeling and record-keeping practices.