FDA Inspection 996935 — Karl Storz Endovision, Inc.

Karl Storz Endovision, Inc. — FEI 1221826

The FDA completed an inspection of Karl Storz Endovision, Inc. on December 20, 2016 in Charlton, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 20, 2016
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Charlton, MA (United States)

Citations

IDCFRDescription
326621 CFR 820.86Acceptance status