Home / Import refusals / AEK-7679375-9/20002/1

FDA Import Refusal AEK-7679375-9/20002/1 — Boehringer Ingelheim Pharma GmbH & Co. KG

Boehringer Ingelheim Pharma GmbH & Co. KG — FEI 3002806556

The FDA refused shipment AEK-7679375-9/20002/1 from Boehringer Ingelheim Pharma GmbH & Co. KG (Germany) on October 21, 2025. The refused product falls under Drugs and Biologics — EMPAGLIFLOZIN (ANTI-DIABETIC). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
October 21, 2025
Country
Germany
Product Category
Drugs and Biologics
Product Code
61PCY73 EMPAGLIFLOZIN (ANTI-DIABETIC)
Charges
75

Recent inspections

  • 1315938 (VAI Thu May 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1208521 (VAI Thu Oct 07 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1053519 (VAI Fri May 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 962108 (VAI Tue Mar 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 921540 (NAI Fri Jan 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 1FX-9193352-2/10002/1 (Wed Jun 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 1FX-3564313-8/10002/1 (Wed May 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9152797-6/10002/1 (Sun Jan 18 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7894740-3/10002/1 (Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-8221344-1/10002/1 (Fri Nov 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources