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FDA Import Refusal 112-9667034-6/1/1 — Janssen Ortho LLC

Janssen Ortho LLC — FEI 3002942061

The FDA refused shipment 112-9667034-6/1/1 from Janssen Ortho LLC (United States) on November 19, 2010. The refused product falls under Drugs and Biologics — TOPIRAMATE (ANTI-CONVULSANT). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
November 19, 2010
Country
United States
Product Category
Drugs and Biologics
Product Code
61MCA40 TOPIRAMATE (ANTI-CONVULSANT)
Charges
75

Recent inspections

  • 1200973 (VAI Tue Mar 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1063744 (VAI Tue Aug 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1012089 (VAI Fri May 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 930456 (VAI Fri May 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 819622 (VAI Fri Feb 22 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-5056653-8/41/1 (Mon Oct 25 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 916-4055433-2/11/1 (Tue Nov 12 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-5576956-2/1/1 (Fri May 27 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-4271132-1/2/1 (Tue Mar 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9622023-7/1/1 (Tue Aug 31 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources