FDA Inspection
Biocoat, Inc.Biocoat, Inc. – FDA Inspection, Nov 17, 2017
Record Details
This FDA Inspection record concerns Biocoat, Inc., with an inspection on November 17, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b8336b7d-647e-4bb0-a86f-1f3054549a71
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1032373
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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