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1169814

Covidien — FEI 3003495548

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 28, 2022
Fiscal Year
2022
Product Type
Devices
Project Area
Compliance: Devices
Location
San Isidro (Dominican Republic (the))

Facility

Other inspections at this facility

  • 1036260 (NAI Wed Aug 09 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 900524 (NAI Fri Aug 22 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 739627 (NAI Wed Aug 17 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
312021 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
54621 CFR 820.75(a)Lack of or inadequate process validation