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FDA Import Refusal AEK-9592348-6/10002/1A — Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory)

Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory) — FEI 3012333115

The FDA refused shipment AEK-9592348-6/10002/1A from Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory) (South Korea) on September 16, 2026. The refused product falls under Drugs and Biologics — ONABOTULINUMTOXINA. Cited charges: 118,3280,472,75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
September 16, 2026
Country
South Korea
Product Category
Drugs and Biologics
Product Code
58PCZ05 ONABOTULINUMTOXINA
Charges
118,3280,472,75

Recent inspections

  • 1179508 (VAI Wed Aug 24 2022 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 1FX-3872001-8/20002/1A (Fri Sep 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0899181-1/10002/1 (Fri Sep 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-7980201-3/10002/2E (Wed Aug 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0699449-4/20002/1 (Thu Aug 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9592341-1/10002/1 (Mon Aug 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources