483
TRIUMPH PHARMACEUTICALS INCTRIUMPH PHARMACEUTICALS INC – FDA 483, Apr 29, 2025
Record Details
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.
View Company Profile
ID · f0991fd4-3b56-4e3d-aa8f-21483be4081f
Other documents for TRIUMPH PHARMACEUTICALS INC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.