Home / Import refusals / AEK-9331637-8/10002/1

FDA Import Refusal AEK-9331637-8/10002/1 — Gedeon Richter Nyrt.

Gedeon Richter Nyrt. — FEI 3002806761

The FDA refused shipment AEK-9331637-8/10002/1 from Gedeon Richter Nyrt. (Hungary) on February 20, 2026. The refused product falls under Drugs and Biologics — NORETHINDRONE ACETATE (PROGESTIN). Cited charge: 75 This firm has 5 or more other import refusals on record.

Refusal Details

Date
February 20, 2026
Country
Hungary
Product Category
Drugs and Biologics
Product Code
65JDY25 NORETHINDRONE ACETATE (PROGESTIN)
Charges
75

Recent inspections

  • 1301414 (NAI Fri Jul 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1207513 (VAI Fri Jun 03 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1009633 (NAI Fri Mar 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 883062 (VAI Fri May 23 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 738485 (VAI Tue Jul 12 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-9723169-2/12/1 (Tue Aug 05 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-4488756-1/11/1 (Mon May 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-0256152-0/21/1 (Wed Dec 30 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-8004336-6/11/1 (Fri Sep 04 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7493422-2/31/1 (Wed Jun 17 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources