FDA Inspection 672689 — Rudolf Riester Gmbh
The FDA completed an inspection of Rudolf Riester Gmbh on Jun 24, 2010 in Jungingen. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 24, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Jungingen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3837 | 21 CFR 820.25(b) | Training records |