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928802

Cepheid — FEI 3004530258

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 16, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Compliance: Devices
Location
Sunnyvale, CA (United States)

Facility

Other inspections at this facility

  • 1026773 (NAI Wed Aug 09 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 763635 (NAI Fri Jan 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 695802 (VAI Fri Oct 29 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 612704 (NAI Wed Sep 16 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
317221 CFR 820.198(c)Investigation of device failures
319221 CFR 820.30(g)Design validation - user needs and intended uses
73221 CFR 803.50(a)(2)Individual Report of Malfunction