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1177544

CardioFocus, Inc. — FEI 3001451473

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 11, 2022
Fiscal Year
2022
Product Type
Devices
Project Area
Radiation Control and Health Safety Act
Location
Marlborough, MA (United States)

Facility

Other inspections at this facility

  • 1016613 (NAI Fri Jun 30 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 928695 (NAI Thu May 07 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 808977 (NAI Wed Nov 28 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 746966 (NAI Fri Sep 23 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
316821 CFR 820.198(a)Complaints
368321 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements