954571

Sucampo Pharma, LLC — FEI 3009036781

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 16, 2015
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Kobe (Japan)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
242021 CFR 211.198(a)Quality Control Review