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1019958

CME America, LLC — FEI 3006967710

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 1, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Golden, CO (United States)

Facility

Other inspections at this facility

  • 1049514 (NAI Mon Apr 23 2018 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
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
333121 CFR 820.181DMR - not or inadequately maintained
342521 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
54621 CFR 820.75(a)Lack of or inadequate process validation