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FDA Import Refusal AEK-9519768-5/10002/1 — Kolmar Korea Co. Ltd.

Kolmar Korea Co. Ltd. — FEI 3004033751

The FDA refused shipment AEK-9519768-5/10002/1 from Kolmar Korea Co. Ltd. (South Korea) on March 3, 2026. The refused product falls under Drugs and Biologics — MISCELLANEOUS PATENT MEDICINES, ETC.. Cited charges: 118,27,75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
March 3, 2026
Country
South Korea
Product Category
Drugs and Biologics
Product Code
66VIL99 MISCELLANEOUS PATENT MEDICINES, ETC.
Charges
118,27,75

Recent inspections

  • 1028265 (OAI Thu Sep 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 923033 (VAI Fri Apr 03 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 842594 (VAI Fri Jul 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 1FX-0437636-4/20002/2 (Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-2445501-6/40002/1 (Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-7046792-2/20002/1 (Thu May 14 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-8431524-7/10004/1 (Wed Mar 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AV3-0058410-7/70003/1 (Mon Mar 23 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources