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Janssen Ortho LLC — FDA Facility Profile

FEI 3002942061

Janssen Ortho LLC is an FDA-registered facility (FEI 3002942061) located in Gurabo, PR, US. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 6 FDA inspections at this facility.

Facility Details

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

Recent inspections

  • 1200973 (VAI Tue Mar 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1063744 (VAI Tue Aug 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1012089 (VAI Fri May 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 930456 (VAI Fri May 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 819622 (VAI Fri Feb 22 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 729698 (VAI Mon Jun 13 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • 799-5056653-8/41/1 (Mon Oct 25 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-5576956-2/1/1 (Fri May 27 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 799-4271132-1/2/1 (Tue Mar 15 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-9667034-6/1/1 (Fri Nov 19 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9622023-7/1/1 (Tue Aug 31 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources