FDA Inspection 1182389 — Cane S.P.A.
The FDA completed an inspection of Cane S.P.A. on Oct 27, 2022 in RIVOLI-CASCINE. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 27, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- RIVOLI-CASCINE (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |