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Janssen Biologics B.V. — FDA Facility Profile

FEI 3002806632

Janssen Biologics B.V. is an FDA-registered facility (FEI 3002806632) located in Leiden, NL. Registered operations: ANALYSIS; API MANUFACTURE. RegDataLab tracks 7 FDA inspections at this facility.

Facility Details

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

Recent inspections

  • 1272273 (VAI Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1126291 (VAI Thu Oct 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1076442 (NAI Fri Jun 15 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 975458 (NAI Fri May 27 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 891657 (VAI Fri Jul 11 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 813923 (VAI Fri Sep 28 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 679919 (NAI Tue Jul 06 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • 1FX-0489887-9/10002/1 (Fri Apr 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-0149781-6/10002/1 (Fri Apr 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-7490829-7/10002/1 (Mon Nov 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-5453929-9/11/1 (Wed Jul 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-5453860-6/11/1 (Mon Jul 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-9803723-8/11/1 (Mon Mar 11 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 8NP-0055905-8/11/1 (Mon Apr 19 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 916-4133847-9/11/1 (Fri Feb 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources