FDA Inspection
TRIUMPH PHARMACEUTICALS INCTRIUMPH PHARMACEUTICALS INC – FDA Inspection, Jan 19, 2023
Record Details
This FDA Inspection record concerns TRIUMPH PHARMACEUTICALS INC, with an inspection on January 19, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 902fc456-5db0-457b-a163-8f99b39a81b6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1196117
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(1)Documented evaluation
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Other FDA inspections of TRIUMPH PHARMACEUTICALS INC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 29, 2025 | NAI | Kansas City District Office | Postmarket Assurance: Medical Devices |
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