1119635

Bionen S.r.l. — FEI 3008617703

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 20, 2020
Fiscal Year
2020
Product Type
Devices
Project Area
Compliance: Devices
Location
Florence (Italy)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
54621 CFR 820.75(a)Lack of or inadequate process validation