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Bayer AG — FDA Facility Profile

FEI 3002806462

Bayer AG is an FDA-registered facility (FEI 3002806462) located in Leverkusen, NW, DE. Registered operations: ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK; PARTICLE SIZE REDUCTION. RegDataLab tracks 9 FDA inspections and 1 compliance action at this facility.

Facility Details

Location
Leverkusen, NW (DE)
Registration Expires
December 31, 2026
Operations
ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK; PARTICLE SIZE REDUCTION
Source
decrs

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))
  • 975815 (NAI Fri Jun 03 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 905879 (VAI Fri Nov 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 791785 (VAI Mon Jul 09 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 651524 (VAI Tue Feb 23 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • AEK-7770178-5/30002/1 (Mon Jan 26 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9203188-7/10002/1 (Tue Jan 20 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • F23-9339962-1/110002/1 (Wed Sep 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • F23-9339758-3/110002/1 (Wed Sep 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-7261205-2/32/1 (Wed Jul 23 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 9UA-0323395-6/72/1H (Wed Jul 16 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0333993-2/21/1 (Mon Jan 31 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8421813-7/51/1 (Mon Nov 22 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9373110-4/41/1 (Fri Jul 16 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-2442037-4/11/1 (Tue Jun 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources