FDA Inspection 1024021 — Trinity Biotech USA
The FDA completed an inspection of Trinity Biotech USA on September 1, 2017 in Jamestown, NY. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 1, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Jamestown, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |