FDA Inspection 1280847 — In2Bones, SAS
The FDA completed an inspection of In2Bones, SAS on Sep 4, 2025 in Ecully. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 4, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: 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 |