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1021632

ELITechGroup, Inc. — FEI 1717966

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 11, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Logan, UT (United States)

Facility

Other inspections at this facility

  • 930474 (VAI Wed May 27 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 737028 (VAI Fri Jul 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 606798 (VAI Wed Jul 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
235021 CFR 820.25(b)Training - Lack of or inadequate procedures
311721 CFR 820.70(i)Software validation for automated processes
323221 CFR 820.72(a)Equipment suitability & capability
332321 CFR 820.170(b)Installer records
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
54621 CFR 820.75(a)Lack of or inadequate process validation