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673687

Medtronic Puerto Rico Operations Co. — FEI 2647346

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 27, 2010
Fiscal Year
2010
Product Type
Devices
Project Area
Postmarket Assurance: 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))
  • 726009 (VAI Fri May 13 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
343221 CFR 820.75(b)(2)Documentation of validated process performance
369621 CFR 820.100(b)Documentation
383721 CFR 820.25(b)Training records
420821 CFR 806.20(a)Records not kept