FDA Inspection
Dr. Gernot Schuhfried Ges.m.b.H.Dr. Gernot Schuhfried Ges.m.b.H. – FDA Inspection, May 18, 2017
Record Details
This FDA Inspection record concerns Dr. Gernot Schuhfried Ges.m.b.H., with an inspection on May 18, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bb5f7fcb-1fe6-483f-998a-6f8533d4c958
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1018320
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(g)Design validation - software validation documentation
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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