Home / Import refusals / AEK-9362796-4/10002/1

FDA Import Refusal AEK-9362796-4/10002/1 — Rottendorf Pharma Gmbh

Rottendorf Pharma Gmbh — FEI 3003732290

The FDA refused shipment AEK-9362796-4/10002/1 from Rottendorf Pharma Gmbh (Germany) on February 10, 2026. 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
February 10, 2026
Country
Germany
Product Category
Drugs and Biologics
Product Code
61PDA73 EMPAGLIFLOZIN (ANTI-DIABETIC)
Charges
75

Recent inspections

  • 1303578 (VAI Thu Mar 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1247046 (VAI Thu May 06 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1083771 (VAI Thu Feb 21 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1005464 (VAI Fri Feb 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 875352 (NAI Fri Mar 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • AEK-0593779-1/10002/9 (Tue May 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-9791643-5/10003/1 (Fri Feb 06 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7887918-4/10002/1 (Tue Nov 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7253524-6/12/1 (Wed Aug 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7320062-6/22/1 (Fri Jul 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources