Home / Import refusals / 799-4747673-3/11/1

FDA Import Refusal 799-4747673-3/11/1 — Glaxo Operations U.K. Ltd.

Glaxo Operations U.K. Ltd. — FEI 3002807078

The FDA refused shipment 799-4747673-3/11/1 from Glaxo Operations U.K. Ltd. (United Kingdom) on December 26, 2019. The refused product falls under Drugs and Biologics — AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
December 26, 2019
Country
United Kingdom
Product Category
Drugs and Biologics
Product Code
56BCY03 AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
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