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1053901

Patheon Puerto Rico, Inc. — FEI 3003113148

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 31, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Manati, PR (United States)

Facility

Other inspections at this facility

  • 1174359 (VAI Tue Jul 12 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1106702 (VAI Tue Oct 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 976890 (VAI Tue Jun 21 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 941475 (VAI Thu Sep 03 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 891131 (VAI Mon Aug 11 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
163021 CFR 211.130(b)Unlabeled filled containers controls
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls