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FDA Import Refusal E4J-0051280-2/11/1 — Lelypharma BV

Lelypharma BV — FEI 3015660451

The FDA refused shipment E4J-0051280-2/11/1 from Lelypharma BV (Netherlands) on January 17, 2025. The refused product falls under Drugs and Biologics — DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC). Cited charges: 2280,3902,75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
January 17, 2025
Country
Netherlands
Product Category
Drugs and Biologics
Product Code
61XBL21 DOXYLAMINE SUCCINATE (ANTI-HISTAMINIC)
Charges
2280,3902,75

Recent inspections

  • 1292016 (NAI Fri Sep 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 235-1981530-4/10002/1 (Thu Jan 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • E4J-0051280-2/31/1 (Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • E4J-0051280-2/41/1 (Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • E4J-0051280-2/61/1 (Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • E4J-0051280-2/21/1 (Fri Jan 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources