Home / Inspections / 958547

958547

CME America, LLC — FEI 3006967710

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
February 3, 2016
Fiscal Year
2016
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))
  • 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
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
317221 CFR 820.198(c)Investigation of device failures
340921 CFR 820.200(d)Service reports
342521 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
369621 CFR 820.100(b)Documentation