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983250

Centro de Construccion de Cardioestimuladores del Uruguay SA — FEI 3010326622

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 4, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Montevideo (Uruguay)

Additional Details

Postmarket Audit Inspections

Facility

Other inspections at this facility

  • 1177799 (VAI Thu Aug 18 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1101217 (NAI Thu Aug 01 2019 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