FDA Inspection 668193 — Rhein83 S.R.L.
The FDA completed an inspection of Rhein83 S.R.L. on Jun 17, 2010 in Bologna. 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 17, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bologna (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3309 | 21 CFR 820.120(b) | Examination for accuracy |