FDA Inspection 919373 — Italfarmaco S.p.A.
The FDA completed an inspection of Italfarmaco S.p.A. on March 13, 2015 in Milan. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 13, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Milan (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1918 | 21 CFR 211.166(a)(2) | Stability sample storage conditions described |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |