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FDA Import Refusal AEK-8436787-7/11/1B — Kolmar Korea Co., Ltd. - Gwanjeong Factory

Kolmar Korea Co., Ltd. - Gwanjeong Factory — FEI 3010299845

The FDA refused shipment AEK-8436787-7/11/1B from Kolmar Korea Co., Ltd. - Gwanjeong Factory (South Korea) on May 28, 2025. The refused product falls under Drugs and Biologics — EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.. Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 28, 2025
Country
South Korea
Product Category
Drugs and Biologics
Product Code
66YCY99 EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
Charges
75

Recent inspections

  • 1230224 (VAI Fri Feb 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1173870 (VAI Thu Jul 07 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031995 (VAI Fri Sep 15 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-0364235-1/10002/1A (Thu Jul 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-0644053-0/10002/2A (Thu Apr 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-0644053-0/10002/2B (Thu Apr 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-0279364-1/40003/1 (Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-0279364-1/30003/1 (Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

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