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843462

CME America, LLC — FEI 3006967710

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 6, 2013
Fiscal Year
2013
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))
  • 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))
  • 673879 (VAI Fri Jul 23 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
317221 CFR 820.198(c)Investigation of device failures
333121 CFR 820.181DMR - not or inadequately maintained
342521 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate