939368

Shire Human Genetic Therapies, Inc. — FEI 3009340644

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 15, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lexington, MA (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111221 CFR 211.25(a)Training--operations, GMPs, written procedures