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684575

Event Medical LTD — FEI 3006135941

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 8, 2010
Fiscal Year
2011
Product Type
Devices
Project Area
Compliance: Devices
Location
Lake Forest, CA (United States)

Facility

Other inspections at this facility

  • 1170213 (VAI Wed May 18 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))

Citations

IDCFRDescription
243021 CFR 820.30(b)Design plans - Lack of or inadequate
255721 CFR 820.30(c)Design input - documentation
319121 CFR 820.30(g)Design validation - production units