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FDA Inspection 1285382 — Ardena U.S. LLC

Ardena U.S. LLC — FEI 3003563645

The FDA completed an inspection of Ardena U.S. LLC on November 21, 2025 in Somerset, NJ. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). Product area: Drugs.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
November 21, 2025
Fiscal Year
2026
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Somerset, NJ (United States)

Facility

Other inspections at this facility

  • 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))

FDA data resources