FDA Inspection 1254024 — AXILUM ROBOTICS SAS
The FDA completed an inspection of AXILUM ROBOTICS SAS on Nov 6, 2024 in Schiltigheim. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Nov 6, 2024
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Schiltigheim (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3264 | 21 CFR 820.250(b) | Sampling methods - Lack of or inadequate procedures |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 3696 | 21 CFR 820.100(b) | Documentation |