# FDA 483 - TRIUMPH PHARMACEUTICALS INC - January 19, 2023

Source: https://www.keypedia.com/records/483/triumph-pharmaceuticals-inc/794ec431-1502-4322-9065-28d77529a9b3

> FDA 483 for TRIUMPH PHARMACEUTICALS INC on January 19, 2023. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TRIUMPH PHARMACEUTICALS INC
- Inspection Date: 2023-01-19
- Product Type: devices
- Office Name: Kansas City District Office
- Summary: TRIUMPH PHARMACEUTICALS INC was the subject of an FDA inspection conducted from January 17-19, 2023. The inspection identified several significant deviations from quality system requirements, necessitating prompt corrective action by the medical device manufacturer. The primary issues observed included an inadequately maintained device master record for their SmartMouth DryMouth Oral Rinse product. This record was found to be missing critical information such as quality procedures, acceptance criteria for incoming components and finished devices, assembly instructions, and equipment documentation essential for manufacturing. Moreover, the firm had not established comprehensive procedures for corrective and preventive actions, which are fundamental for identifying, investigating, and resolving quality problems to prevent recurrence. Further observations detailed a lack of written procedures for Medical Device Reporting, which is crucial for identifying and reporting adverse events to the FDA. Inadequate procedures for receiving, reviewing, and evaluating customer complaints were also noted, hindering effective complaint management. Finally, the evaluation of potential suppliers and contractors for the SmartMouth DryMouth Oral Rinse product was not documented, posing risks to material and service quality. These findings collectively point to a need for TRIUMPH PHARMACEUTICALS INC to implement a robust quality management system. The company has committed to correcting each observation, which will require developing and implementing comprehensive procedures to ensure compliance with regulatory standards for medical device manufacturing.

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## Related Officers

- [issuing_officer](https://www.keypedia.com/people/mary-l-schuckmann/fdbfffff-ef4b-49a2-8ea3-6254a600aaac)

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