FDA Inspection 844005 — Bieffe Medital SpA
The FDA completed an inspection of Bieffe Medital SpA on August 15, 2013 in Sondalo. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 15, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Sondalo (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |