Home / Import refusals / AEK-9054909-6/10002/1

FDA Import Refusal AEK-9054909-6/10002/1 — AstraZeneca AB

AstraZeneca AB — FEI 3002806411

The FDA refused shipment AEK-9054909-6/10002/1 from AstraZeneca AB (Sweden) on December 18, 2025. The refused product falls under Drugs and Biologics — DAPAGLIFLOZIN (ANTI-DIABETIC). Cited charges: 118,472 This firm has 5 or more other import refusals on record.

Refusal Details

Date
December 18, 2025
Country
Sweden
Product Category
Drugs and Biologics
Product Code
61PDY70 DAPAGLIFLOZIN (ANTI-DIABETIC)
Charges
118,472

Recent inspections

  • 1327052 (VAI Thu Mar 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1248349 (VAI Thu Dec 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1124752 (VAI Fri Oct 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102604 (VAI Fri Aug 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1010067 (VAI Tue Feb 07 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)
  • 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)
  • AEK-7511982-4/10002/1 (Fri Sep 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources