FDA Inspection 936430 — Advanced Vision Science Inc

Advanced Vision Science Inc — FEI 2020277

The FDA completed an inspection of Advanced Vision Science Inc on August 3, 2015 in Goleta, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 3, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Goleta, CA (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
310421 CFR 820.30(j)Design history file
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures