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Norgine Limited

FDA Regulatory Profile

Norgine Limited has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 20, 2025 · VAI

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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
Inspections2Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 20, 2025Hengoed, United KingdomDrugsVoluntary Action Indicated (VAI)3005202761
Aug 16, 2019Hengoed, United KingdomDrugsVoluntary Action Indicated (VAI)3005202761

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 3005202761Hengoed, United Kingdom2Jun 20, 2025

FDA data resources

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