Company
DenmarkNRT X-RAY A/S, Hasselager, Denmark – FDA Inspections
Inspection records and compliance data for NRT X-RAY A/S in Hasselager. 4 FDA inspections on record, 2 Form 483s, last inspected February 06, 2026.
Company Profile
This profile covers NRT X-RAY A/S based in Hasselager, Denmark.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected January 22, 2010. Last inspected February 6, 2026.
Most cited issue areas
- Appropriate action not taken for nonconforming product after delivery or use1 inspection
- Certification label or tag1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 6, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1301478 |
| March 24, 2023 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1200620 |
| July 31, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 938460 |
| January 22, 2010 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 643990 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
NRT X-RAY A/S
FEI Number
1000188474
Address
Birkegardsvej 16, Hasselager, Denmark
Country
Denmark
ID: 9dc2935b-a2f9-499d-bda1-66ebc0af0b4a