FDA 483 - Airway Management, Inc - March 13, 2020

Airway Management, Inc. in Carrollton, TX, was inspected from March 9-13, 2020, and received one observation. The inspection revealed significant deficiencies in the firm's complaint handling procedures, particularly regarding the timely processing, evaluation, and assessment of Medical Device Report (MDR) reportable events. The firm also lacked a clear definition of "serious injury" in its MDR procedure.