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Unetixs Vascular, Inc. — FEI 1222117

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 3, 2011
Fiscal Year
2011
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))
  • 1055132 (OAI Mon Jun 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1006990 (OAI Wed Mar 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471021 CFR 820.150Lack of or inadequate procedures for storage.
237121 CFR 820.30(a)Design control - no procedures
315921 CFR 820.184DHR content
317221 CFR 820.198(c)Investigation of device failures
369621 CFR 820.100(b)Documentation