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1022176

SynCardia Systems LLC — FEI 3003761017

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 18, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Tucson, AZ (United States)

Facility

Other inspections at this facility

  • 1079700 (NAI Thu Nov 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 922825 (VAI Fri Apr 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 826059 (NAI Thu Mar 28 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 746232 (VAI Fri Sep 23 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
73121 CFR 803.50(a)(1)Report of Death or Serious Injury