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1080642

Medtronic Puerto Rico Operations Co. — FEI 3004369318

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 21, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Juncos, PR (United States)

Facility

Other inspections at this facility

  • 1257491 (NAI Fri Mar 14 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1106993 (VAI Fri Oct 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1052808 (OAI Tue May 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023269 (VAI Tue Aug 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1003102 (VAI Fri Feb 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures