Home / Import refusals / AEK-5850833-2/31/1

FDA Import Refusal AEK-5850833-2/31/1 — AstraZeneca Pharmaceuticals LP

AstraZeneca Pharmaceuticals LP — FEI 1825662

The FDA refused shipment AEK-5850833-2/31/1 from AstraZeneca Pharmaceuticals LP (United States) on November 1, 2024. The refused product falls under Drugs and Biologics — DAPAGLIFLOZIN (ANTI-DIABETIC). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
November 1, 2024
Country
United States
Product Category
Drugs and Biologics
Product Code
61PCB70 DAPAGLIFLOZIN (ANTI-DIABETIC)
Charges
75

Recent inspections

  • 1218331 (VAI Tue Sep 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 965123 (NAI Thu Jan 28 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 853863 (VAI Fri Oct 25 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 798609 (NAI Thu Sep 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 751470 (VAI Fri Oct 28 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 1FX-0410784-2/10001/1 (Fri May 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0593779-1/20001/1 (Tue May 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-5525737-9/10001/1 (Fri Mar 27 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-1544392-9/10001/1 (Tue Feb 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9333932-1/20001/1 (Thu Jan 22 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources