FDA Inspection 1017474 — Intelligent Endoscopy

Intelligent Endoscopy — FEI 3011324403

The FDA completed an inspection of Intelligent Endoscopy on July 11, 2017 in Clemmons, NC. 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
July 11, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Clemmons, NC (United States)

Citations

IDCFRDescription
312721 CFR 820.80(e)Documentation