FDA Inspection 949845 — FIAB Spa
The FDA completed an inspection of FIAB Spa on Nov 12, 2015 in Vicchio. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 12, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Vicchio (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |