1015197

Trividia Health, Inc. — FEI 1000113657

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 22, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Fort Lauderdale, FL (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures
63121 CFR 803.17(a)(1)Lack of System for Event Evaluations