1059203

Helena Laboratories UK Ltd — FEI 3009736003

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 18, 2018
Fiscal Year
2018
Product Type
Devices
Project Area
Compliance: Devices
Location
Gateshead Newcastle (United Kingdom)

Citations

IDCFRDescription
1472021 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
313021 CFR 820.100(a)Lack of or inadequate procedures