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1161837

Xellia Pharmaceuticals USA LLC — FEI 3012279857

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 7, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Bedford, OH (United States)

Facility

Other inspections at this facility

  • 1220071 (VAI Fri Sep 29 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1194565 (VAI Thu Dec 15 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1117006 (VAI Fri Jan 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 990058 (NAI Thu Oct 13 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

  • Injunction (311) (Thu Jan 31 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed