FDA Inspection
Digiray CorpDigiray Corp – FDA Inspection, Mar 16, 2017
Record Details
This FDA Inspection record concerns Digiray Corp, with an inspection on March 16, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · b2d80c36-8e00-425e-a218-4b2768de8d84
Inspection Facts
- Inspection number
- 1008523
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - software validation not performed
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
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