740132

Vivax Medical Corp. — FEI 1000513669

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 11, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Compliance: Devices
Location
Naugatuck, CT (United States)

Citations

IDCFRDescription
229321 CFR 820.20(d)Quality plan
312721 CFR 820.80(e)Documentation
317521 CFR 820.186QSR
333121 CFR 820.181DMR - not or inadequately maintained
341521 CFR 820.22Quality Audit/Reaudit - conducted