1307128
TriRx Medical, LLC — FEI 3027390974
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 6, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Naples, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23167 | ISO 13485:2016 Clause 7.5.6 | Process for production and service provision not validated |
| 23231 | ISO 13485:2016 Clause 8.2.6 | Evidence of conformity to the acceptance criteria not maintained |
| 23239 | ISO 13485:2016 Clause 8.3.1 | Records of nonconforming product and actions taken not maintained |