1279188
Nexxt Spine, LLC — FEI 3007922509
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 11, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Noblesville, IN (United States)
Citations
| ID | CFR | Description |
|---|
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |