Home / Inspections / 985597

985597

Patheon Manufacturing Services LLC — FEI 1018495

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 17, 2015
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Greenville, NC (United States)

Facility

Other inspections at this facility

  • 1270187 (NAI Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1229060 (VAI Fri Feb 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1176425 (VAI Thu Aug 04 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1096860 (NAI Fri May 17 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1060475 (VAI Tue Jul 17 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
139521 CFR 211.103Actual vs. theoretical yields not determined
180921 CFR 211.160(a)Following/documenting laboratory controls
434221 CFR 211.142(b)Storage under appropriate conditions