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Richter Gedeon Nyrt. — FDA Facility Profile

FEI 3002806761

Richter Gedeon Nyrt. is an FDA-registered facility (FEI 3002806761) located in Hungary (HUN). Registered operations: ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK. RegDataLab tracks 5 FDA inspections at this facility.

Facility Details

Location
Hungary (HUN)
Registration Expires
December 31, 2026
Operations
ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK
Source
decrs

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))

Import refusals

  • AEK-9331637-8/10002/1 (Fri Feb 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 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)
  • AEK-7457232-9/11/1 (Mon Jun 08 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-6243563-8/11/1 (Mon Oct 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-1417300-8/11/2 (Wed May 29 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-5240906-5/21/1 (Wed Apr 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources