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1040994

Patheon Pharmaceuticals Inc. — FEI 1510437

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 14, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Cincinnati, OH (United States)

Facility

Other inspections at this facility

  • 1281564 (VAI Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1204466 (NAI Fri Apr 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1117783 (NAI Tue Jan 14 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1003802 (VAI Thu Mar 02 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 966241 (VAI Fri Mar 11 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
135821 CFR 211.100(b)SOPs not followed / documented
202821 CFR 211.192Extent of discrepancy, failure investigations
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
356521 CFR 211.58Buildings not maintained in good state of repair