FDA Inspection 1206032 — SMEG S.P.A.
The FDA completed an inspection of SMEG S.P.A. on May 11, 2023 in Guastalla. 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
- May 11, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Guastalla (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 5034 | 21 CFR 1010.2(c) | Certification not based on adequate test/testing program |
| 5122 | 21 CFR 1030.10(c)(3)(iii) | Measurements with tap water container |
| 5940 | 21 CFR 1030.10(c)(3)(i) | tests--errors and uncertainties accounted for |
| 5941 | 21 CFR 1030.10(c)(3)(iii) | Water container specs |