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1055132

Unetixs Vascular, Inc. — FEI 1222117

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 11, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Compliance: Devices
Location
Warwick, RI (United States)

Facility

Other inspections at this facility

  • 1180260 (VAI Fri Sep 16 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1147542 (VAI Fri Jul 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1107891 (OAI Tue Oct 29 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1006990 (OAI Wed Mar 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 728239 (VAI Fri Jun 03 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures
334521 CFR 820.200(a)Servicing - Lack of or inadequate procedures