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960445

RS Medical — FEI 1000117825

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 18, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Compliance: Devices
Location
Vancouver, WA (United States)

Facility

Other inspections at this facility

  • 1119162 (NAI Thu Feb 27 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 820874 (VAI Fri Mar 15 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 658446 (VAI Wed Apr 14 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1472221 CFR 820.40Procedures not adequately established or maintained
313021 CFR 820.100(a)Lack of or inadequate procedures
323121 CFR 820.70(i)Documentation of software validation
383721 CFR 820.25(b)Training records