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FDA Import Refusal AEK-7885543-2/10002/1 — Fareva Unterach GmbH

Fareva Unterach GmbH — FEI 3002829723

The FDA refused shipment AEK-7885543-2/10002/1 from Fareva Unterach GmbH (Austria) on December 1, 2025. The refused product falls under Drugs and Biologics — METHOTREXATE (ANTI-NEOPLASTIC). Cited charges: 118,3280,75 This firm has 2 other import refusals on record.

Refusal Details

Date
December 1, 2025
Country
Austria
Product Category
Drugs and Biologics
Product Code
62IDA31 METHOTREXATE (ANTI-NEOPLASTIC)
Charges
118,3280,75

Recent inspections

  • 1234631 (VAI Thu Jun 02 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1133019 (VAI Wed Jul 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1088868 (VAI Wed May 08 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 911762 (NAI Thu Dec 18 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 803791 (OAI Tue Oct 23 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 799-6494410-7/1/1 (Thu Jul 28 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 147-0106353-0/2/1 (Tue Dec 15 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources