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866797

Burke, Inc. — FEI 1919278

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 7, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Kansas City, KS (United States)

Facility

Other inspections at this facility

  • 1148691 (NAI Fri Aug 13 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1013314 (NAI Thu Jun 08 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 677920 (VAI Fri Aug 27 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 565408 (VAI Thu Feb 05 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
319321 CFR 820.30(g)Design validation - simulated testing