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1011967

Cook Incorporated — FEI 1825146

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
May 26, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Spencer, IN (United States)

Facility

Other inspections at this facility

  • 845571 (NAI Tue Jul 30 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 640284 (VAI Wed Jan 20 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
311921 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
54621 CFR 820.75(a)Lack of or inadequate process validation