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CELLTRION Inc — FDA Facility Profile

FEI 3005241015

CELLTRION Inc is an FDA-registered facility (FEI 3005241015) located in South (KOR). Registered operations: ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK. RegDataLab tracks 7 FDA inspections and 1 compliance action at this facility.

Facility Details

Location
South (KOR)
Registration Expires
December 31, 2026
Operations
ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK
Source
decrs

Recent inspections

  • 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))
  • 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))
  • 926632 (NAI Thu Apr 09 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • AEK-9482743-0/11/1 (Fri Jul 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9482743-0/21/1 (Fri Jul 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources