Home / Import refusals / AEK-8401476-8/141/1

FDA Import Refusal AEK-8401476-8/141/1 — AstraZeneca AB

AstraZeneca AB — FEI 3003342394

The FDA refused shipment AEK-8401476-8/141/1 from AstraZeneca AB (Sweden) on May 28, 2025. The refused product falls under Drugs and Biologics — ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 28, 2025
Country
Sweden
Product Category
Drugs and Biologics
Product Code
62TDA06 ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY)
Charges
75

Recent inspections

  • 1295446 (NAI Thu Nov 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1248230 (VAI Thu Dec 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1143443 (VAI Fri Dec 06 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1115572 (VAI Thu Dec 07 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007887 (NAI Fri Jan 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-7960283-3/10003/1 (Fri Dec 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9054909-6/10002/1 (Thu Dec 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-7648528-6/20002/1 (Mon Nov 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7697916-8/20002/1 (Thu Oct 09 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-3728327-7/10002/1 (Tue Sep 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources