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1018699

Motion Analysis Corporation — FEI 2939117

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 21, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Santa Rosa, CA (United States)

Facility

Other inspections at this facility

  • 1003151 (VAI Mon Nov 07 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 834109 (VAI Sun Jun 02 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 741250 (NAI Wed Aug 24 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
310421 CFR 820.30(j)Design history file
311721 CFR 820.70(i)Software validation for automated processes
313021 CFR 820.100(a)Lack of or inadequate procedures
333121 CFR 820.181DMR - not or inadequately maintained
367121 CFR 820.25(a)Personnel
419121 CFR 806.10(a)(1)Report of risk to health
63221 CFR 803.17(a)(2)Lack of System for Determining MDR Events