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1065689

Patheon Inc. — FEI 3003516812

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 14, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Whitby (Canada)

Facility

Other inspections at this facility

  • 1198322 (VAI Fri Feb 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1002468 (NAI Fri Dec 09 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 976246 (VAI Fri Feb 26 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 878561 (NAI Fri Apr 04 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 836167 (VAI Fri May 24 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
184221 CFR 211.84(d)(1)Component identity verification
360321 CFR 211.160(b)Scientifically sound laboratory controls
430321 CFR 211.67(b)Written procedures fail to include
440221 CFR 211.192Written record of investigation incomplete