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1058538

Karl Storz Endovision, Inc. — FEI 1221826

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 14, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Compliance: Devices
Location
Charlton, MA (United States)

Facility

Other inspections at this facility

  • 1171793 (NAI Tue Jun 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1152207 (NAI Fri Sep 17 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 996935 (VAI Tue Dec 20 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 947594 (OAI Thu Oct 22 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 902419 (OAI Wed Oct 29 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures