# FDA 483 - TRIUMPH PHARMACEUTICALS INC - April 29, 2025

Source: https://www.keypedia.com/records/483/triumph-pharmaceuticals-inc/f0991fd4-3b56-4e3d-aa8f-21483be4081f

> FDA 483 for TRIUMPH PHARMACEUTICALS INC on April 29, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TRIUMPH PHARMACEUTICALS INC
- Inspection Date: 2025-04-29
- Product Type: device
- Office Name: Kansas City District Office
- Summary: 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.

## Related Documents

- [483 - 2023-01-19](https://www.keypedia.com/records/483/triumph-pharmaceuticals-inc/9bd2116b-ffb1-46a9-9270-0edbb70cc686)

## Related Officers

- [Edward E. Lockwood](https://www.keypedia.com/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.keypedia.com/companies/triumph-pharmaceuticals-inc/3d5a3dad-b74e-4bd5-910b-22a207d327f4

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79