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1227972

GlaxoSmithKline Vaccines Srl — FEI 3006738517

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 26, 2024
Fiscal Year
2024
Product Type
Biologics
Project Area
Vaccines and Allergenic Products
Location
Sovicille (Italy)

Facility

Other inspections at this facility

  • 1092542 (VAI Thu Jun 06 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 947755 (VAI Fri Jun 26 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 848028 (VAI Tue Jun 18 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 604816 (VAI Fri Jul 31 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111121 CFR 211.25(a)Training , Education , Experience overall
180921 CFR 211.160(a)Following/documenting laboratory controls
202721 CFR 211.192Investigations of discrepancies, failures
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report