TRIUMPH PHARMACEUTICALS INC – FDA 483, Jan 19, 2023

An FDA inspection of TRIUMPH PHARMACEUTICALS INC in Saint Louis, MO, revealed significant deficiencies in their quality system for medical device manufacturing. The firm failed to adequately maintain device master records, establish corrective and preventive action procedures, and implement medical device reporting procedures. Additionally, inadequate complaint handling and undocumented supplier evaluations were noted, indicating a broad lack of essential quality controls.