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1154244

Cook Incorporated — FEI 1820334

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 14, 2021
Fiscal Year
2021
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Bloomington, IN (United States)

Facility

Other inspections at this facility

  • 1229533 (VAI Wed May 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1117146 (VAI Fri Feb 07 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1057227 (VAI Thu Jun 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1000728 (VAI Thu Jan 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 918323 (NAI Fri Mar 13 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
311921 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
53921 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.