Home / Import refusals / F23-9339758-3/110002/1

FDA Import Refusal F23-9339758-3/110002/1 — Bayer AG

Bayer AG — FEI 3002806462

The FDA refused shipment F23-9339758-3/110002/1 from Bayer AG (Germany) on September 3, 2025. The refused product falls under Drugs and Biologics — RIVAROXABAN. Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
September 3, 2025
Country
Germany
Product Category
Drugs and Biologics
Product Code
61LCA42 RIVAROXABAN
Charges
75

Recent inspections

  • 1247034 (VAI Thu Sep 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1209999 (NAI Fri May 13 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1125538 (VAI Mon Jul 27 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1084360 (OAI Fri Mar 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1004195 (OAI Fri Jan 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 1FX-3328450-6/10002/1 (Tue Jul 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-3328450-6/20002/1 (Tue Jul 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-3328450-6/30002/1 (Tue Jul 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0551263-6/20002/1 (Fri Jun 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-0817933-5/30002/1A (Mon Jun 08 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources