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Janssen Biotech, Inc. — FDA Facility Profile

FEI 3001610451

Janssen Biotech, Inc. is an FDA-registered facility (FEI 3001610451) located in Malvern, PA, US. Registered operations: ANALYSIS; API MANUFACTURE; MANUFACTURE. RegDataLab tracks 10 or more FDA inspections at this facility.

Facility Details

Location
Malvern, PA (US)
Registration Expires
December 31, 2026
Operations
ANALYSIS; API MANUFACTURE; MANUFACTURE
Source
decrs

Recent inspections

  • 1276933 (VAI Tue Jul 29 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1265723 (NAI Mon Mar 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1077487 (NAI Fri Nov 30 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1046499 (VAI Mon Mar 05 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031776 (VAI Tue Nov 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1007329 (NAI Mon Feb 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 939172 (NAI Wed Aug 19 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 897031 (VAI Wed Sep 24 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 801737 (NAI Tue Sep 25 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 789675 (VAI Fri Jun 15 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • NUV-3855286-8/80002/1 (Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • NUV-3849644-7/30002/1 (Mon Nov 03 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources