TRIUMPH PHARMACEUTICALS INCApril 29, 2025

FDA 483 - TRIUMPH PHARMACEUTICALS INC - April 29, 2025

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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.

Company: TRIUMPH PHARMACEUTICALS INC
Inspection Date: April 29, 2025
Product Type: Device
Office: Kansas City District Office
Person: Edward E. Lockwood

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