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Hovione LLC

FDA Regulatory Profile

Hovione LLC has 0 FDA recalls, 10 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 11, 2025 · NAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections10Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 11, 2025East Windsor, NJDrugsNo Action Indicated (NAI)3006106736
Jan 20, 2023Ringaskiddy, IrelandDrugsNo Action Indicated (NAI)3008058822
Feb 22, 2022Ringaskiddy, IrelandDrugsVoluntary Action Indicated (VAI)3008058822
Jan 22, 2020East Windsor, NJDrugsVoluntary Action Indicated (VAI)3006106736
Dec 22, 2017Ringaskiddy, IrelandDrugsNo Action Indicated (NAI)3008058822
Dec 16, 2015East Windsor, NJDrugsVoluntary Action Indicated (VAI)3006106736
Jul 25, 2014Ringaskiddy, IrelandDrugsNo Action Indicated (NAI)3008058822
Apr 26, 2013East Windsor, NJDrugsNo Action Indicated (NAI)3006106736
Mar 16, 2012Ringaskiddy, IrelandDrugsVoluntary Action Indicated (VAI)3008058822
May 2, 2011East Windsor, NJDrugsNo Action Indicated (NAI)3006106736

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 3006106736East Windsor, NJ5Jun 11, 2025
FEI 3008058822Ringaskiddy, Ireland5Jan 20, 2023

FDA data resources

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