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Ardena U.S. LLC — FDA Facility Profile

FEI 3003563645

Ardena U.S. LLC is an FDA-registered facility (FEI 3003563645) located in Somerset, NJ, US. Registered operations: ANALYSIS; MANUFACTURE. RegDataLab tracks 10 or more FDA inspections at this facility.

Facility Details

Location
Somerset, NJ (US)
Registration Expires
December 31, 2026
Operations
ANALYSIS; MANUFACTURE
Source
decrs

Recent inspections

  • 1285382 (NAI Fri Nov 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1199635 (NAI Wed Feb 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1063006 (NAI Fri Jul 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1039238 (NAI Fri Jan 19 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 989308 (NAI Mon Oct 24 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 915355 (NAI Tue Feb 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 871530 (NAI Thu Apr 03 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 812939 (NAI Wed Dec 19 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 769326 (NAI Fri Feb 17 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 710053 (VAI Fri Feb 18 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • 112-0111611-3/1/2 (Tue Mar 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-0111611-3/1/1 (Tue Mar 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-9837194-3/1/1 (Fri Jun 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-0193504-1/1/1 (Fri Jun 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-0168724-6/1/1 (Thu May 31 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-0168724-6/1/2 (Thu May 31 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-9239828-0/1/2 (Wed May 30 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-9239828-0/1/1 (Wed May 30 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-8271065-0/1/1 (Fri Apr 06 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-8537872-9/1/2 (Mon Oct 03 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources