FDA Inspection 896708 — AESDEX

AESDEX — FEI 3004114958

The FDA completed an inspection of AESDEX on September 18, 2014 in Redwood City, 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
September 18, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Redwood City, CA (United States)

Citations

IDCFRDescription
73821 CFR 803.52(a)(1)Patient Name or Other Identifier