FDA Inspection 850924 — Actavis Italy Spa A Socio Unico
The FDA completed an inspection of Actavis Italy Spa A Socio Unico on September 27, 2013 in Nerviano. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 27, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Nerviano (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1433 | 21 CFR 211.42(c)(10)(iii) | Air Supply |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |