FDA Inspection
NRT X-RAY A/SNRT X-RAY A/S – FDA Inspection, Mar 24, 2023
Record Details
This FDA Inspection record concerns NRT X-RAY A/S, with an inspection on March 24, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b800bd85-ed8b-4579-b35b-4b72daba6adf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1200620
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 1010.2(b)Certification label or tag
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 1010.2(b)Certification label or tag
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of NRT X-RAY A/S
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 6, 2026 | Not classified | Office of Inspections and Investigations | Compliance: Medical 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 1301478 - 2026-02-06
- FDA Inspection 938460 - 2015-07-31
- FDA Inspection 643990 - 2010-01-22
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