FDA Inspection
Quest Medical ImagingQuest Medical Imaging – FDA Inspection, Apr 12, 2018
Record Details
This FDA Inspection record concerns Quest Medical Imaging, with an inspection on April 12, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · f809d3c7-2e59-424f-a460-d8511d2bfce4
Inspection Facts
- Inspection number
- 1047856
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.184DHR content
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.75(a)Lack of or inadequate process validation
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