FDA Inspection 794237 — Tonica Elektronik A/S
The FDA completed an inspection of Tonica Elektronik A/S on Aug 2, 2012 in Farum. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Aug 2, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Farum (Denmark)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 537 | 21 CFR 820.70(a) | Production processes |