Home / Import refusals / AEK-3164647-1/11/1

FDA Import Refusal AEK-3164647-1/11/1 — GlaxoSmithKline LLC

GlaxoSmithKline LLC — FEI 1035048

The FDA refused shipment AEK-3164647-1/11/1 from GlaxoSmithKline LLC (United States) on May 10, 2017. The refused product falls under Drugs and Biologics — LAMOTRIGINE (ANTI-CONVULSANT). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 10, 2017
Country
United States
Product Category
Drugs and Biologics
Product Code
61MCA38 LAMOTRIGINE (ANTI-CONVULSANT)
Charges
75

Recent inspections

  • 1230726 (NAI Fri Aug 16 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1103284 (NAI Thu Sep 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 988235 (NAI Fri Jul 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 921712 (NAI Fri Apr 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 898235 (NAI Mon Sep 29 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 1FX-0333205-3/10002/1 (Fri Jun 12 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-9324952-1/30002/1 (Tue Jun 02 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • NUV-3881703-0/70002/1 (Tue Feb 24 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9318923-9/110002/1 (Thu Feb 19 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9449370-5/10003/1 (Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

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