Home / Import refusals / AEK-0768123-1/10002/1

FDA Import Refusal AEK-0768123-1/10002/1 — Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory)

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

The FDA refused shipment AEK-0768123-1/10002/1 from Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory) (South Korea) on July 10, 2026. The refused product falls under Drugs and Biologics — ONABOTULINUMTOXINA. Cited charges: 472,75 This firm has 3 other import refusals on record.

Refusal Details

Date
July 10, 2026
Country
South Korea
Product Category
Drugs and Biologics
Product Code
58PCZ05 ONABOTULINUMTOXINA
Charges
472,75

Recent inspections

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

Other import refusals

  • SCS-4197260-1/100003/1 (Tue Jan 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-1138342-4/13/4 (Mon Jun 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-1029583-2/11/1 (Thu Jun 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources