FDA Inspection 1205340 — ACS Dobfar SPA (Plant #2)
The FDA completed an inspection of ACS Dobfar SPA (Plant #2) on May 16, 2023 in Tribiano. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 16, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tribiano (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |