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FDA Import Refusal 8B4-0006193-1/201/1 — SmithKline Beecham Limited

SmithKline Beecham Limited — FEI 1000166776

The FDA refused shipment 8B4-0006193-1/201/1 from SmithKline Beecham Limited (United Kingdom) on June 27, 2024. 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
June 27, 2024
Country
United Kingdom
Product Category
Drugs and Biologics
Product Code
56BCA03 AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
Charges
75

Recent inspections

  • 934743 (OAI Fri Jul 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 803789 (VAI Fri Oct 19 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 717039 (OAI Fri Mar 18 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 799-2525285-1/41/1 (Tue Jul 23 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-3916609-7/11/2 (Thu Feb 25 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-2489323-0/11/1 (Thu Sep 28 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8014221-5/1/1 (Tue Jun 08 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-8418463-0/1/1 (Fri Oct 30 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources