FDA Inspection 938460 — NRT X-RAY A/S
The FDA completed an inspection of NRT X-RAY A/S on July 31, 2015 in Hasselager. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- July 31, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hasselager (Denmark)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 5008 | 21 CFR 1002.20(a) | Failure to report |
| 5012 | 21 CFR 1003.10(a) | FDA not notified of defect or noncompliance |