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FDA Import Refusal 799-8098524-4/11/1 — Takeda GmbH, Plant Oranienburg

Takeda GmbH, Plant Oranienburg — FEI 3002807809

The FDA refused shipment 799-8098524-4/11/1 from Takeda GmbH, Plant Oranienburg (Germany) on August 12, 2020. The refused product falls under Drugs and Biologics — EMTRICITABINE; TENOFOVIR DISOPROXIL FUMERATE (ANTI-VIRAL). Cited charge: 118 This firm has 5 or more other import refusals on record.

Refusal Details

Date
August 12, 2020
Country
Germany
Product Category
Drugs and Biologics
Product Code
62VDA77 EMTRICITABINE; TENOFOVIR DISOPROXIL FUMERATE (ANTI-VIRAL)
Charges
118

Recent inspections

  • 1309958 (VAI Fri Nov 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1156027 (VAI Fri Oct 30 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1047651 (VAI Fri Mar 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 969059 (VAI Fri Mar 11 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 869665 (VAI Fri Nov 15 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • F23-9339758-3/130002/1 (Wed Sep 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-1834016-4/21/1 (Fri Oct 07 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-6808919-2/21/1 (Tue Feb 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-7085949-1/1/1 (Wed Oct 17 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-7085949-1/1/2 (Wed Oct 17 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources