FDA Inspection 1254216 — BTS S.p.A.
The FDA completed an inspection of BTS S.p.A. on November 15, 2024 in Vigonza. 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
- November 15, 2024
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Vigonza (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |