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FDA Inspection 976869 — Akorn Operating Company LLC

Akorn Operating Company LLC — FEI 2246848

The FDA completed an inspection of Akorn Operating Company LLC on April 4, 2016 in Somerset, 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
April 4, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Somerset, NJ (United States)

Facility

Other inspections at this facility

  • 1169676 (OAI Tue May 17 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1012024 (NAI Fri May 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 929221 (VAI Fri Jun 05 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 884894 (VAI Thu May 29 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 814789 (VAI Fri Feb 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources