FDA Inspection 819603 — Trividia Health, Inc.

Trividia Health, Inc. — FEI 1000113657

The FDA completed an inspection of Trividia Health, Inc. on February 15, 2013 in Fort Lauderdale, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 15, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: 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
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures
73221 CFR 803.50(a)(2)Individual Report of Malfunction