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FDA Inspection 725155 — Akorn Operating Company LLC

Akorn Operating Company LLC — FEI 2246848

The FDA completed an inspection of Akorn Operating Company LLC on May 19, 2011 in Somerset, 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
May 19, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Somerset, NJ (United States)

Citations

IDCFRDescription
188321 CFR 211.165(a)Testing and release for distribution

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))
  • 976869 (NAI Mon Apr 04 2016 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))

Recent compliance actions

FDA data resources