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FDA Import Refusal 8JB-0220025-9/10002/1 — OSANG Healthcare CO., LTD.

OSANG Healthcare CO., LTD. — FEI 3004146366

The FDA refused shipment 8JB-0220025-9/10002/1 from OSANG Healthcare CO., LTD. (South Korea) on April 16, 2026. The refused product falls under Devices — SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER. Cited charges: 476,508 This firm has 4 other import refusals on record.

Refusal Details

Date
April 16, 2026
Country
South Korea
Product Category
Devices
Product Code
75NBW SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
Charges
476,508

Recent inspections

  • 872689 (OAI Thu Feb 20 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 731667 (VAI Fri May 13 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 8JB-0219282-9/10002/1 (Thu Mar 05 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • AEK-8679785-6/11/1 (Fri Jan 29 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-3484941-6/11/1 (Fri Jan 08 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-5244048-4/1/1 (Thu Mar 15 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources