Home / Inspections / 841054

841054

Patheon Italia S.p.A — FEI 3004110157

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 21, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Ferentino (Italy)

Facility

Other inspections at this facility

  • 1306942 (NAI Fri Jan 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1174972 (NAI Tue Jun 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1247104 (VAI Fri Feb 25 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1066263 (VAI Fri Sep 21 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1006748 (NAI Mon Oct 31 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
122721 CFR 211.67(c)Cleaning/maintenance records not kept
150421 CFR 211.122(d)Labels and labeling stored separately
241921 CFR 211.198(a)Complaint Handling Procedure
358521 CFR 211.110(a)Control procedures to monitor and validate performance
431421 CFR 211.84(d)(2)Reports of Analysis (Components)