853812

Diagnostica Stago, Inc. — FEI 2245451

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 8, 2013
Fiscal Year
2014
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Parsippany, NJ (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
337221 CFR 820.198(d)Records of MDR Investigation
73221 CFR 803.50(a)(2)Individual Report of Malfunction