FDA Inspection 1180922 — Rudischhauser Surgical Instruments Manufacturing GmbH
The FDA completed an inspection of Rudischhauser Surgical Instruments Manufacturing GmbH on Sep 21, 2022 in Tuttlingen. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 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 |