FDA 483 - TRIUMPH PHARMACEUTICALS INC - April 29, 2025

An FDA inspection of Triumph Pharmaceuticals Inc., a specification developer of SmartMouth DryMouth Oral Rinse, revealed significant deficiencies in their compliance with medical device regulations. The firm failed to apply unique device identifiers (UDI) to its product and lacked an adequately established and maintained organizational structure for device design and production, including critical quality system procedures.