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FDA Import Refusal U59-2022326-5/11/1 — Evonik Operations GmbH

Evonik Operations GmbH — FEI 3002806792

The FDA refused shipment U59-2022326-5/11/1 from Evonik Operations GmbH (Germany) on April 10, 2025. The refused product falls under Drugs and Biologics — AZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC). Cited charge: 3280 This firm has 4 other import refusals on record.

Refusal Details

Date
April 10, 2025
Country
Germany
Product Category
Drugs and Biologics
Product Code
61XDS50 AZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC)
Charges
3280

Recent inspections

  • 1323502 (VAI Thu Oct 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1233622 (VAI Thu Oct 29 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1030819 (VAI Fri Sep 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 870086 (VAI Fri Mar 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 737851 (VAI Fri Jul 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-8712945-3/1/1 (Tue Apr 21 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 916-2681216-7/1/1 (Tue Jul 08 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-7842534-7/1/1 (Fri Jan 06 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-7364361-9/1/1 (Tue Jul 26 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources