FDA Inspection 717756 — Artsana S.p.A.
The FDA completed an inspection of Artsana S.p.A. on January 27, 2011 in Casnate Con Bernate. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 27, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Casnate Con Bernate (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |