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1093395

Catalent Belgium SA — FEI 3007647000

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 19, 2019
Fiscal Year
2019
Product Type
Biologics
Project Area
Vaccines and Allergenic Products
Location
Brussels (Belgium)

Facility

Other inspections at this facility

  • 1246550 (VAI Fri Apr 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1177876 (VAI Fri Aug 19 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1136201 (VAI Wed Jan 22 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1061068 (NAI Tue Jul 31 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1019956 (VAI Fri Jul 07 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
145121 CFR 211.113(b)Procedures for sterile drug products
240121 CFR 211.194(a)(4)Complete Test Data
358521 CFR 211.110(a)Control procedures to monitor and validate performance