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1011975

Electro-Diagnostic Imaging, Inc. — FEI 3002900377

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 26, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Milpitas, CA (United States)

Facility

Other inspections at this facility

  • 837440 (NAI Wed Jun 26 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 752868 (VAI Thu Nov 03 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 651866 (VAI Mon Feb 22 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471721 CFR 820.30(g)Design validation - software validation documentation
255721 CFR 820.30(c)Design input - documentation
310421 CFR 820.30(j)Design history file
313021 CFR 820.100(a)Lack of or inadequate procedures
367121 CFR 820.25(a)Personnel
367421 CFR 820.30(d)Design output - documentation