Home / Import refusals / AEK-8490998-3/12/1

FDA Import Refusal AEK-8490998-3/12/1 — Pfizer Ireland Pharmaceuticals Unlimited Company

Pfizer Ireland Pharmaceuticals Unlimited Company — FEI 3006785053

The FDA refused shipment AEK-8490998-3/12/1 from Pfizer Ireland Pharmaceuticals Unlimited Company (Ireland) on June 30, 2025. The refused product falls under Drugs and Biologics — APIXABAN (ANTI-COAGULANT). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
June 30, 2025
Country
Ireland
Product Category
Drugs and Biologics
Product Code
61LCA44 APIXABAN (ANTI-COAGULANT)
Charges
75

Recent inspections

  • 1231009 (VAI Fri Sep 23 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1128858 (VAI Fri Sep 27 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1053147 (NAI Fri Apr 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 980507 (VAI Fri Jul 29 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 933818 (VAI Fri Jun 12 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 1FX-6085920-3/10002/1 (Wed Apr 29 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-3659938-4/10002/1 (Mon Sep 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-3879430-6/10002/1 (Thu Sep 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-3207634-6/10002/1 (Tue Aug 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-8180521-2/12/1 (Thu Jul 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources