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1187489

HansBiomed USA, Inc. — FEI 3008778066

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 8, 2022
Fiscal Year
2023
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Englewood Cliffs, NJ (United States)

Facility

Other inspections at this facility

  • 1181084 (NAI Tue Sep 27 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1107099 (NAI Tue Sep 03 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 941986 (NAI Mon Sep 14 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 825938 (VAI Tue Apr 02 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
337521 CFR 820.198(e)Records of complaint investigation
405921 CFR 820.22Quality Audits - defined intervals
63021 CFR 803.17Lack of Written MDR Procedures