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FDA Inspection 1283944 — Unette Corp

Unette Corp — FEI 2210679

The FDA completed an inspection of Unette Corp on September 11, 2025 in Randolph, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 11, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Randolph, NJ (United States)

Citations

IDCFRDescription
202721 CFR 211.192Investigations of discrepancies, failures

Facility

Other inspections at this facility

  • 1174882 (NAI Wed Jun 22 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 995374 (NAI Wed Dec 28 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 887795 (NAI Wed Jul 16 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 766946 (VAI Wed Feb 15 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 632621 (VAI Wed Dec 30 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources