FDA Inspection 1200620 — NRT X-RAY A/S
The FDA completed an inspection of NRT X-RAY A/S on March 24, 2023 in Hasselager. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 24, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hasselager (Denmark)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 5032 | 21 CFR 1010.2(b) | Certification label or tag |