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Bayer HealthCare, LLC — FDA Facility Profile

FEI 2243252

Bayer HealthCare, LLC is an FDA-registered facility (FEI 2243252) located in Morristown, NJ, US. RegDataLab tracks 10 or more FDA inspections at this facility.

Facility Details

Location
Morristown, NJ (US)
Registration Expires
N/A
Operations
Source
device

Recent inspections

  • 1286004 (NAI Mon Oct 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1277153 (NAI Fri Aug 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1251837 (NAI Tue Dec 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1196111 (NAI Wed Feb 08 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1153395 (NAI Wed Sep 15 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1067092 (NAI Thu Aug 09 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1017417 (NAI Tue Jun 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 918283 (NAI Wed Mar 18 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 849853 (NAI Tue Sep 24 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 673859 (NAI Fri Jul 30 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • 799-6429231-1/11/1 (Mon Jan 03 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-0256520-8/11/1 (Thu Jan 07 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-0475966-0/11/4 (Fri Jun 19 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-6264407-2/11/1 (Mon Sep 16 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-2900582-1/11/1 (Fri Feb 10 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-8849362-4/1/1 (Wed May 30 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-8021688-6/1/1 (Wed Dec 23 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-5660799-8/2/1 (Thu Nov 05 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SG5-0417413-0/1/1 (Wed Apr 30 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources