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FDA Import Refusal SCS-1138342-4/13/4 — Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory)

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

The FDA refused shipment SCS-1138342-4/13/4 from Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory) (South Korea) on June 30, 2025. The refused product falls under Drugs and Biologics — ONABOTULINUMTOXINA. Cited charge: 75 This firm has 3 other import refusals on record.

Refusal Details

Date
June 30, 2025
Country
South Korea
Product Category
Drugs and Biologics
Product Code
58PCZ05 ONABOTULINUMTOXINA
Charges
75

Recent inspections

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

Other import refusals

  • AEK-0768123-1/10002/1 (Fri Jul 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-4197260-1/100003/1 (Tue Jan 20 2026 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