FDA Inspection 1224728 — Meneghetti Spa Sede Legal
The FDA completed an inspection of Meneghetti Spa Sede Legal on Dec 12, 2023 in Rosa'. 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
- Dec 12, 2023
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Rosa' (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 5034 | 21 CFR 1010.2(c) | Certification not based on adequate test/testing program |
| 5123 | 21 CFR 1030.10(c)(3)(iv) | Door position |
| 5940 | 21 CFR 1030.10(c)(3)(i) | tests--errors and uncertainties accounted for |
| 5943 | 21 CFR 1030.10(c)(2)(i) | One interlock concealed and not operable b y human |