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Akorn Operating Company LLC

FDA Regulatory Profile

Akorn Operating Company LLC has 0 FDA recalls, 12 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
May 17, 2022 · OAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections12Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 17, 2022Somerset, NJVeterinaryOfficial Action Indicated (OAI)2246848
Nov 16, 2018Cranbury, NJDrugsNo Action Indicated (NAI)3013036275
May 23, 2017Cranbury, NJDrugsNo Action Indicated (NAI)3013036275
May 12, 2017Somerset, NJDrugsNo Action Indicated (NAI)2246848
Apr 4, 2016Somerset, NJDrugsVoluntary Action Indicated (VAI)2246848
Jun 5, 2015Somerset, NJDrugsVoluntary Action Indicated (VAI)2246848
May 29, 2014Somerset, NJDrugsVoluntary Action Indicated (VAI)2246848
Feb 1, 2013Somerset, NJVeterinaryVoluntary Action Indicated (VAI)2246848
May 11, 2012Somerset, NJDrugsVoluntary Action Indicated (VAI)2246848
May 19, 2011Somerset, NJDrugsVoluntary Action Indicated (VAI)2246848
Oct 6, 2009Somerset, NJDrugsNo Action Indicated (NAI)2246848
Jun 12, 2009Somerset, NJDrugsNo Action Indicated (NAI)2246848

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 2246848Somerset, NJ10May 17, 2022
FEI 3013036275Cranbury, NJ2Nov 16, 2018

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.