1069058

Imaging Biometrics LLC — FEI 3007225492

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 12, 2018
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Elm Grove, WI (United States)

Citations

IDCFRDescription
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
337521 CFR 820.198(e)Records of complaint investigation
63221 CFR 803.17(a)(2)Lack of System for Determining MDR Events