Home / Inspections / 947594

947594

Karl Storz Endovision, Inc. — FEI 1221826

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 22, 2015
Fiscal Year
2016
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))
  • 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))
  • 902419 (OAI Wed Oct 29 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
235021 CFR 820.25(b)Training - Lack of or inadequate procedures
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
317221 CFR 820.198(c)Investigation of device failures
419221 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
53721 CFR 820.70(a)Production processes
54621 CFR 820.75(a)Lack of or inadequate process validation