Home / Import refusals / SCS-0349383-8/40002/1

FDA Import Refusal SCS-0349383-8/40002/1 — Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory)

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

The FDA refused shipment SCS-0349383-8/40002/1 from Daewoong Pharmaceutical Co. Ltd. (Hyangnam factory) (South Korea) on July 31, 2026. The refused product falls under Drugs and Biologics — ONABOTULINUMTOXINA. Cited charges: 9999978,9999979,9999981,9999982,9999983 This firm has 5 or more other import refusals on record.

Refusal Details

Date
July 31, 2026
Country
South Korea
Product Category
Drugs and Biologics
Product Code
58PCY05 ONABOTULINUMTOXINA
Charges
9999978,9999979,9999981,9999982,9999983

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)
  • AEK-9592348-6/10002/1A (Wed Sep 16 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)

FDA data resources