601426

AstraZeneca Pharmaceuticals LP — FEI 3004829714

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 16, 2009
Fiscal Year
2009
Product Type
Biologics
Project Area
Vaccines and Allergenic Products
Location
Philadelphia, PA (United States)

Citations

IDCFRDescription
145121 CFR 211.113(b)Procedures for sterile drug products
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
359121 CFR 211.110(b)In-process materials specifications
908621 CFR 600.14(a)(1)Who must report - manufacturer
908921 CFR 600.14(c)When to report