713353

Envoy Medical Corporation — FEI 3004007782

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 11, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Saint Paul, MN (United States)

Additional Details

Postmarket Audit Inspections

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
369621 CFR 820.100(b)Documentation