FDA Inspection 1270562 — UNOX SPA
The FDA completed an inspection of UNOX SPA on May 13, 2025 in Cadoneghe. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 13, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Cadoneghe (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 5034 | 21 CFR 1010.2(c) | Certification not based on adequate test/testing program |
| 5940 | 21 CFR 1030.10(c)(3)(i) | tests--errors and uncertainties accounted for |