FDA Inspection
Cortical Metrics LLCCortical Metrics LLC – FDA Inspection, Dec 20, 2018
Record Details
This FDA Inspection record concerns Cortical Metrics LLC, with an inspection on December 20, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fb113aea-82a6-44c4-90af-75f21a3dbf6c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1077329
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(e)Maintained
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.86Acceptance status
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