Home / Inspections / 1024197

1024197

George King Bio-Medical, Inc. — FEI 1928890

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 6, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Overland Park, KS (United States)

Facility

Other inspections at this facility

  • 1276234 (NAI Wed Jul 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1181783 (NAI Thu Oct 13 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 991776 (NAI Thu Oct 27 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 903607 (NAI Thu Nov 13 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 803190 (NAI Tue Oct 16 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1472221 CFR 820.40Procedures not adequately established or maintained
311721 CFR 820.70(i)Software validation for automated processes
323121 CFR 820.70(i)Documentation of software validation
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
366621 CFR 820.20(c)Management review - Lack of or inadequate procedures
369621 CFR 820.100(b)Documentation