Home / Import refusals / SCS-3652676-7/10002/1

FDA Import Refusal SCS-3652676-7/10002/1 — GlaxoSmithKline Research & Development Limited

GlaxoSmithKline Research & Development Limited — FEI 3003284850

The FDA refused shipment SCS-3652676-7/10002/1 from GlaxoSmithKline Research & Development Limited (United Kingdom) on September 24, 2025. The refused product falls under Drugs and Biologics — AZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
September 24, 2025
Country
United Kingdom
Product Category
Drugs and Biologics
Product Code
61XDQ50 AZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC)
Charges
75

Recent inspections

  • 1158637 (VAI Tue May 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 984370 (VAI Fri Jun 24 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 802584 (VAI Thu Oct 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 643994 (VAI Thu Dec 17 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • SCS-1344998-1/11/1 (Fri May 13 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-3292711-5/11/1 (Mon Jan 04 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-3852276-4/1/1 (Wed Apr 30 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-9592679-7/1/2 (Tue Jun 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-9592679-7/1/3 (Tue Jun 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources