Home / Import refusals / AEK-1909035-4/11/1

FDA Import Refusal AEK-1909035-4/11/1 — Glaxo Operations U.K. Ltd.

Glaxo Operations U.K. Ltd. — FEI 3002807078

The FDA refused shipment AEK-1909035-4/11/1 from Glaxo Operations U.K. Ltd. (United Kingdom) on November 9, 2022. The refused product falls under Drugs and Biologics — CEFUROXIME AXETIL (CEPHALOSPORINS). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
November 9, 2022
Country
United Kingdom
Product Category
Drugs and Biologics
Product Code
56CCY71 CEFUROXIME AXETIL (CEPHALOSPORINS)
Charges
75

Recent inspections

  • 1209851 (VAI Fri Feb 10 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1014765 (VAI Fri Jun 02 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 933676 (VAI Tue Jun 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 831335 (VAI Thu May 09 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 746871 (VAI Thu Sep 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • F23-9340161-7/100002/1 (Wed Sep 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • F23-9339962-1/20002/1 (Wed Sep 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-7743582-6/22/1 (Wed Jul 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-1708781-0/11/1 (Mon Jun 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-4793666-9/11/1 (Fri Mar 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources