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Bayer AG — FDA Facility Profile

FEI 3002808084

Bayer AG is an FDA-registered facility (FEI 3002808084) located in Bergkamen, DE. Registered operations: ANALYSIS; API MANUFACTURE. RegDataLab tracks 7 FDA inspections and 1 compliance action at this facility.

Facility Details

Location
Bergkamen (DE)
Registration Expires
December 31, 2026
Operations
ANALYSIS; API MANUFACTURE
Source
decrs

Recent inspections

  • 1282946 (VAI Thu Nov 14 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1126224 (VAI Thu Oct 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1062335 (NAI Fri Jun 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 949853 (NAI Thu Nov 12 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 837370 (VAI Fri May 24 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 651516 (NAI Fri Feb 12 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 573369 (OAI Tue Mar 10 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • SCS-6682973-3/11/1 (Tue Mar 21 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-6858429-2/11/1 (Tue Oct 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-0244565-9/1/1 (Thu Dec 06 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 169-3176522-2/1/1 (Mon Aug 20 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 169-3173435-0/1/1 (Wed Jan 03 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-2897635-5/1/1 (Wed Sep 13 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-2897635-5/1/2 (Wed Sep 13 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-1996091-3/1/1 (Wed Jul 26 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 110-1526324-1/1/1 (Tue Aug 02 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-4604015-8/1/1 (Mon Nov 22 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources