Home / Import refusals / AEK-9482743-0/11/1

FDA Import Refusal AEK-9482743-0/11/1 — Celltrion Inc.

Celltrion Inc. — FEI 3005241015

The FDA refused shipment AEK-9482743-0/11/1 from Celltrion Inc. (South Korea) on July 30, 2021. The refused product falls under Drugs and Biologics — TENOFOVIR DISOPROXIL FUMERATE. Cited charge: 75 This firm has 1 other import refusal on record.

Refusal Details

Date
July 30, 2021
Country
South Korea
Product Category
Drugs and Biologics
Product Code
62VDY15 TENOFOVIR DISOPROXIL FUMERATE
Charges
75

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))

Compliance actions

Other import refusals

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

FDA data resources