Home / Import refusals / NUV-3855286-8/70002/1

FDA Import Refusal NUV-3855286-8/70002/1 — Samsung Biologics Co., Ltd.

Samsung Biologics Co., Ltd. — FEI 3010479596

The FDA refused shipment NUV-3855286-8/70002/1 from Samsung Biologics Co., Ltd. (South Korea) on November 4, 2025. The refused product falls under Drugs and Biologics — ADALIMUMAB-BWWD. Cited charge: 3280 This firm has 2 other import refusals on record.

Refusal Details

Date
November 4, 2025
Country
South Korea
Product Category
Drugs and Biologics
Product Code
58SCP01 ADALIMUMAB-BWWD
Charges
3280

Recent inspections

  • 1218067 (VAI Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1201856 (VAI Tue Feb 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1108244 (VAI Fri Nov 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056899 (VAI Tue Jun 26 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 788-1799197-5/11/1 (Wed Jun 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 788-1775925-7/11/1 (Fri Sep 16 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources