FDA Inspection 621498 — Bieffe Medital SpA
The FDA completed an inspection of Bieffe Medital SpA on Oct 16, 2009 in Sondalo. 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). 7 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 16, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Sondalo (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3304 | 21 CFR 820.100(a)(5) | Changes to correct/prevent quality problems |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3689 | 21 CFR 820.100(a)(2) | Investigation |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |