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1237995

Celltrion Inc. — FEI 3005241015

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 3, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Yeonsu District (Korea (the Republic of))

Additional Details

Sponsor, Contract Research Organization

Facility

Other inspections at this facility

  • 1233221 (VAI Tue Feb 27 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1177098 (VAI Fri Jun 03 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1108245 (VAI Tue Oct 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1061388 (VAI Tue Jul 17 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1013498 (OAI Fri Jun 02 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
748221 CFR 312.50General responsibilities of sponsors
909321 CFR 600.80(b)Review of Adverse Experiences - SOPs
909921 CFR 600.80(c)(1)(iii)Reporting Requirements - submission of reports