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891131

Patheon Puerto Rico, Inc. — FEI 3003113148

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 11, 2014
Fiscal Year
2014
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))
  • 1053901 (VAI Thu May 31 2018 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))

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
136121 CFR 211.100(a)Absence of Written Procedures
188321 CFR 211.165(a)Testing and release for distribution
360321 CFR 211.160(b)Scientifically sound laboratory controls
361621 CFR 211.165(d)Acceptance criteria for sampling & testing