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FDA Inspection 1269549 — Elite Laboratories Inc.

Elite Laboratories Inc. — FEI 3002644678

The FDA completed an inspection of Elite Laboratories Inc. on August 1, 2025 in Northvale, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 1, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Northvale, NJ (United States)

Facility

Other inspections at this facility

  • 1120647 (VAI Fri Mar 13 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1119158 (NAI Tue Jan 21 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1042332 (NAI Fri Feb 02 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1038658 (NAI Mon Dec 04 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1014880 (VAI Mon Apr 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources