1180922
Rudischhauser Surgical Instruments Manufacturing GmbH — FEI 3008237805
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 21, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tuttlingen (Germany)
Citations
| ID | CFR | Description |
|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |