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695802

Cepheid — FEI 3004530258

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 29, 2010
Fiscal Year
2011
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))
  • 928802 (VAI Tue Jun 16 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 763635 (NAI Fri Jan 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 612704 (NAI Wed Sep 16 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
316821 CFR 820.198(a)Complaints
63221 CFR 803.17(a)(2)Lack of System for Determining MDR Events