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1152207

Karl Storz Endovision, Inc. — FEI 1221826

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
September 17, 2021
Fiscal Year
2021
Product Type
Devices
Project Area
Postmarket Assurance: 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))
  • 1058538 (VAI Thu Jun 14 2018 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
1471621 CFR 820.30(f)Design verification - output does not meet input requirement
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
310421 CFR 820.30(j)Design history file