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635722

AstraZeneca Pharmaceuticals LP — FEI 3004829714

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 7, 2009
Fiscal Year
2010
Product Type
Biologics
Project Area
Vaccines and Allergenic Products
Location
Philadelphia, PA (United States)

Facility

Other inspections at this facility

  • 1277181 (NAI Tue Jun 24 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1175133 (VAI Fri Jul 22 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1060670 (VAI Wed Jun 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 940375 (VAI Wed May 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 846805 (VAI Wed May 22 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
136121 CFR 211.100(a)Absence of Written Procedures
144821 CFR 211.111Establishment of time limitations
145121 CFR 211.113(b)Procedures for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
440221 CFR 211.192Written record of investigation incomplete