FDA Inspection 768222 — Aziende Chimiche Riunite Angelini Francesco S.P.A.
The FDA completed an inspection of Aziende Chimiche Riunite Angelini Francesco S.P.A. on Jan 26, 2012 in Casella. 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 26, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Casella (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3200 | 21 CFR 820.40(a) | Document locations, Dissemination, etc. |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |