483
Airway Management, IncAirway Management, Inc – FDA 483, Mar 13, 2020
Record Details
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.
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ID · 9d28a8d1-60ed-4da1-9d4e-c7a94c5e0900
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