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1206297

Patheon Italia S.p.A. — FEI 3003065803

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 26, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Monza (Italy)

Facility

Other inspections at this facility

  • 1220064 (VAI Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1238005 (VAI Thu Jan 26 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1206091 (VAI Fri Apr 08 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1130741 (VAI Fri Jul 05 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1041862 (NAI Tue Feb 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
145121 CFR 211.113(b)Procedures for sterile drug products
434221 CFR 211.142(b)Storage under appropriate conditions