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730081

Premier Heart, LLC — FEI 3003289183

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 10, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Port Washington, NY (United States)

Facility

Other inspections at this facility

  • 1256892 (NAI Fri Nov 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1153701 (NAI Tue Sep 28 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1040432 (VAI Thu Feb 08 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 931172 (NAI Thu Jun 11 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 822887 (VAI Fri Mar 15 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
320421 CFR 820.40(b)Change records, content
323121 CFR 820.70(i)Documentation of software validation
337521 CFR 820.198(e)Records of complaint investigation