Home / Inspections / 1049514

1049514

CME America, LLC — FEI 3006967710

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
April 23, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Golden, CO (United States)

Facility

Other inspections at this facility

  • 1019958 (NAI Tue Aug 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 958547 (NAI Wed Feb 03 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 843462 (NAI Tue Aug 06 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 673879 (VAI Fri Jul 23 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471621 CFR 820.30(f)Design verification - output does not meet input requirement
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures