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797053

Zevex, Inc. — FEI 1000117172

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 30, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Salt Lake City, UT (United States)

Facility

Other inspections at this facility

  • 1065820 (VAI Mon Sep 17 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1010305 (OAI Thu Apr 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 938132 (OAI Thu Jul 30 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 752747 (VAI Fri Oct 14 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 704438 (OAI Wed Dec 29 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
314921 CFR 820.180Availability
316021 CFR 820.184Lack of or inadequate DHR procedures
317221 CFR 820.198(c)Investigation of device failures
367721 CFR 820.30(g)Design validation - software validation not performed
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate