FDA Inspection 844005 — Bieffe Medital SpA
The FDA completed an inspection of Bieffe Medital SpA on Aug 15, 2013 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 15, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- 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. |