Company
GermanyNoras MRI Products GmbH, Hochberg, Germany – FDA Inspections
Inspection records and compliance data for Noras MRI Products GmbH in Hochberg. 2 FDA inspections on record, 2 Form 483s, last inspected June 19, 2019.
Company Profile
This profile covers Noras MRI Products GmbH based in Hochberg, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected May 17, 2018. Last inspected June 19, 2019.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- DHR content1 inspection
- DMR - not or inadequately maintained1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 19, 2019 | Not classified | Medical Devices & Rad Health | 1143647 |
| May 17, 2018 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1052974 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
Noras MRI Products GmbH
FEI Number
3004929307
Address
Leibnizstr. 4, Hochberg, Germany
Country
Germany
ID: 672e250e-888b-4645-b745-ce166d7d4c54