1280847
In2Bones, SAS — FEI 3010470577
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 4, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Ecully (France)
Citations
| ID | CFR | Description |
|---|
| 21426 | 21 CFR 820.198(e) | Records of complaint investigation - UDI |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |