FDA Inspection
NRT X-RAY A/SNRT X-RAY A/S – FDA Inspection, Feb 6, 2026
Record Details
This FDA Inspection record concerns NRT X-RAY A/S, with an inspection on February 6, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 58f1aaa7-1f3e-4f9d-b64d-95d7003b90cc
Inspection Facts
- Inspection number
- 1301478
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.4.3Purchased product verification activities not established or implemented
- ISO 13485:2016 Clause 8.3.3Appropriate action not taken for nonconforming product after delivery or use
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Other FDA inspections of NRT X-RAY A/S
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 24, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 31, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 22, 2010 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for NRT X-RAY A/S
- FDA Inspection 1200620 - 2023-03-24
- FDA Inspection 938460 - 2015-07-31
- FDA Inspection 643990 - 2010-01-22
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