FDA Inspection 1100981 — National Advanced Endoscopy Devices Inc

National Advanced Endoscopy Devices Inc — FEI 3000204191

The FDA completed an inspection of National Advanced Endoscopy Devices Inc on August 30, 2019 in Canoga Park, CA. 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
August 30, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Canoga Park, CA (United States)

Citations

IDCFRDescription
263021 CFR 820.30(e)Design review - documentation