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977718

Patheon Italia S.p.A. — FEI 3003065803

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 20, 2016
Fiscal Year
2016
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))
  • 1206297 (VAI Fri May 26 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))

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
192621 CFR 211.166(b)Adequate number of batches on stability