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1176425

Patheon Manufacturing Services LLC — FEI 1018495

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 4, 2022
Fiscal Year
2022
Product Type
Biologics
Project Area
Vaccines and Allergenic Products
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))
  • 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))
  • 1055334 (NAI Wed Mar 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
116921 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
145121 CFR 211.113(b)Procedures for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
202821 CFR 211.192Extent of discrepancy, failure investigations