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726009

Medtronic Puerto Rico Operations Co. — FEI 2647346

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 13, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Compliance: Devices
Location
Humacao, PR (United States)

Facility

Other inspections at this facility

  • 1092762 (VAI Fri May 31 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))
  • 673687 (VAI Tue Jul 27 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
312821 CFR 820.90(a)Nonconforming product control
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
369621 CFR 820.100(b)Documentation