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1092762

Medtronic Puerto Rico Operations Co. — FEI 2647346

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 31, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Humacao, PR (United States)

Facility

Other inspections at this facility

  • 1009097 (VAI Fri Mar 31 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 844136 (NAI Tue Jul 16 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 726009 (VAI Fri May 13 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 673687 (VAI Tue Jul 27 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures