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909662

G. Dundas Co Inc — FEI 3019855

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
December 31, 2014
Fiscal Year
2015
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Black Diamond, WA (United States)

Facility

Other inspections at this facility

  • 1101332 (NAI Thu Aug 08 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 779740 (NAI Mon Apr 30 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 701444 (VAI Mon Nov 08 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 591763 (VAI Tue May 26 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471221 CFR 820.184DHR - not or inadequately maintained
232821 CFR 820.22Quality audits - auditor independence
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
333121 CFR 820.181DMR - not or inadequately maintained
45421 CFR 820.40(a)Document review, approval by designated individual