FDA Inspection 760122 — AESDEX

AESDEX — FEI 3004114958

The FDA completed an inspection of AESDEX on December 22, 2011 in Redwood City, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
December 22, 2011
Fiscal Year
2012
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Redwood City, CA (United States)

Citations

IDCFRDescription
319021 CFR 820.30(g)Design validation acceptance criteria