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959996

Cenorin, LLC — FEI 3004153171

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 23, 2015
Fiscal Year
2016
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Kent, WA (United States)

Facility

Other inspections at this facility

  • 1119142 (NAI Fri Feb 14 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 873734 (VAI Fri May 02 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 786847 (NAI Wed Jun 20 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 629671 (VAI Mon Oct 26 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
255721 CFR 820.30(c)Design input - documentation
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
367821 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate