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1170213

Event Medical LTD — FEI 3006135941

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 18, 2022
Fiscal Year
2022
Product Type
Devices
Project Area
Compliance: Devices
Location
Lake Forest, CA (United States)

Facility

Other inspections at this facility

  • 1101502 (NAI Thu Aug 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 897984 (NAI Wed Sep 24 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 744988 (NAI Fri Sep 16 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 684575 (VAI Fri Oct 08 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures