FDA Inspection 1177098 — Celltrion Inc.

Celltrion Inc. — FEI 3005241015

The FDA completed an inspection of Celltrion Inc. on June 3, 2022 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
June 3, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Yeonsu (Korea (the Republic of))