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Janssen-Cilag Manufacturing, LLC — FDA Facility Profile

FEI 3006244497

Janssen-Cilag Manufacturing, LLC is an FDA-registered facility (FEI 3006244497) located in Gurabo, PR, US. Registered operations: ANALYSIS; MANUFACTURE; PACK. RegDataLab tracks 10 or more FDA inspections at this facility.

Facility Details

Location
Gurabo, PR (US)
Registration Expires
December 31, 2026
Operations
ANALYSIS; MANUFACTURE; PACK
Source
decrs

Recent inspections

  • 1302416 (VAI Wed Feb 11 2026 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1158642 (VAI Tue Nov 23 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1029739 (VAI Mon Aug 07 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 998481 (NAI Fri Jan 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 872370 (NAI Mon Feb 24 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 854433 (NAI Wed Oct 23 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 770058 (NAI Tue Nov 22 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 714921 (NAI Fri Feb 18 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 638139 (VAI Wed Dec 16 2009 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 634116 (NAI Thu Dec 03 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • 799-6019836-3/31/1 (Tue Nov 16 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-6019836-3/31/2 (Tue Nov 16 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources