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

Source: https://www.globalkeysolutions.net/records/483/triumph-pharmaceuticals-inc/9bd2116b-ffb1-46a9-9270-0edbb70cc686

> FDA 483 for TRIUMPH PHARMACEUTICALS INC on January 19, 2023. Product: device. 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: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of TRIUMPH PHARMACEUTICALS INC in Saint Louis, MO, revealed significant deficiencies in their quality system for medical device manufacturing. The firm failed to adequately maintain device master records, establish corrective and preventive action procedures, and implement medical device reporting procedures. Additionally, inadequate complaint handling and undocumented supplier evaluations were noted, indicating a broad lack of essential quality controls.

## Related Documents

- [483 - 2025-04-29](https://www.globalkeysolutions.net/records/483/triumph-pharmaceuticals-inc/f0991fd4-3b56-4e3d-aa8f-21483be4081f)

## Related Officers

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

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8