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1302376

Coeur Inc. — FEI 1038185

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 11, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Compliance: Devices
Location
Washington, NC (United States)

Facility

Other inspections at this facility

  • 1047741 (VAI Thu Mar 22 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 988221 (NAI Thu Jul 28 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 795827 (NAI Thu Aug 23 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 572942 (NAI Wed Apr 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
23024ISO 13485:2016 Clause 4.1.5Inadequate monitoring and control over outsourced processes
23213ISO 13485:2016 Clause 8.2.1Information gathered in feedback process not used as input into risk management