FDA Inspection 1266176 — Tonica Elektronik A/S
The FDA completed an inspection of Tonica Elektronik A/S on Mar 27, 2025 in Farum. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 27, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Farum (Denmark)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |