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FDA Inspection 1061388 — Celltrion Inc.

Celltrion Inc. — FEI 3005241015

The FDA completed an inspection of Celltrion Inc. on July 17, 2018 in Yeonsu. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 17, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Yeonsu (Korea (the Republic of))

Facility

Other inspections at this facility

  • 1237995 (VAI Fri May 03 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))
  • 1013498 (OAI Fri Jun 02 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources