FDA Inspection 817988 — Zoe Medical Incorporated

Zoe Medical Incorporated — FEI 3003294644

The FDA completed an inspection of Zoe Medical Incorporated on February 7, 2013 in Topsfield, MA. 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
February 7, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Topsfield, MA (United States)

Citations

IDCFRDescription
368321 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements