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814819

Terumo Cardiovascular Systems Corp — FEI 1000149028

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 17, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Ashland, MA (United States)

Facility

Other inspections at this facility

  • 1026679 (VAI Mon Sep 25 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 660860 (NAI Fri May 07 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471221 CFR 820.184DHR - not or inadequately maintained
313021 CFR 820.100(a)Lack of or inadequate procedures
313221 CFR 820.120Lack of or inadequate procedures for labeling