Home / Import refusals / AEK-7878607-3/161/1

FDA Import Refusal AEK-7878607-3/161/1 — AstraZeneca Pharmaceuticals LP

AstraZeneca Pharmaceuticals LP — FEI 2518137

The FDA refused shipment AEK-7878607-3/161/1 from AstraZeneca Pharmaceuticals LP (United States) on October 8, 2020. 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
October 8, 2020
Country
United States
Product Category
Drugs and Biologics
Product Code
61PDY70 DAPAGLIFLOZIN (ANTI-DIABETIC)
Charges
75

Recent inspections

  • 1247294 (NAI Fri Oct 04 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1219696 (NAI Wed Sep 20 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 930780 (NAI Fri Jun 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 895234 (NAI Tue Aug 26 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 873394 (NAI Mon Apr 07 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

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