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1009097

Medtronic Puerto Rico Operations Co. — FEI 2647346

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 31, 2017
Fiscal Year
2017
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))
  • 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
311921 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
313021 CFR 820.100(a)Lack of or inadequate procedures
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures