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FDA Import Refusal AEK-8679785-6/11/1 — OSANG Healthcare CO., LTD.

OSANG Healthcare CO., LTD. — FEI 3004146366

The FDA refused shipment AEK-8679785-6/11/1 from OSANG Healthcare CO., LTD. (South Korea) on January 29, 2021. The refused product falls under Devices — REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID. Cited charge: 508 This firm has 4 other import refusals on record.

Refusal Details

Date
January 29, 2021
Country
South Korea
Product Category
Devices
Product Code
83QJR REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
Charges
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-0220025-9/10002/1 (Thu Apr 16 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 8JB-0219282-9/10002/1 (Thu Mar 05 2026 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