FDA Inspection
Noras MRI Products GmbHNoras MRI Products GmbH – FDA Inspection, May 17, 2018
Record Details
This FDA Inspection record concerns Noras MRI Products GmbH, with an inspection on May 17, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · b90ce7ea-d9ad-4cd1-99da-6d9ae1835ef5
Inspection Facts
- Inspection number
- 1052974
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184DHR content
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
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Other FDA inspections of Noras MRI Products GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 19, 2019 | Not classified | Office of Inspections and Investigations |
Other documents for Noras MRI Products GmbH
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