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1174359

Patheon Puerto Rico, Inc. — FEI 3003113148

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 12, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Manati, PR (United States)

Facility

Other inspections at this facility

  • 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))
  • 891131 (VAI Mon Aug 11 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
356521 CFR 211.58Buildings not maintained in good state of repair