1101189

DeGen Medical Inc. — FEI 3010663372

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 29, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Florence, SC (United States)

Citations

IDCFRDescription
317221 CFR 820.198(c)Investigation of device failures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures