823932

Cadence Science, Inc. — FEI 1213649

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 26, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Cranston, RI (United States)

Citations

IDCFRDescription
317221 CFR 820.198(c)Investigation of device failures
44721 CFR 820.40Lack of procedures, or not maintained
54621 CFR 820.75(a)Lack of or inadequate process validation
73221 CFR 803.50(a)(2)Individual Report of Malfunction