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Seqirus Inc

FDA Regulatory Profile

Seqirus Inc has 0 FDA recalls, 10 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Jun 5, 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
Inspections10Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 5, 2025Holly Springs, NCBiologicsVoluntary Action Indicated (VAI)3007867647
Jun 9, 2022Holly Springs, NCBiologicsVoluntary Action Indicated (VAI)3007867647
Jun 18, 2018Holly Springs, NCBiologicsVoluntary Action Indicated (VAI)3007867647
Aug 16, 2016Parkville, AustraliaBiologicsVoluntary Action Indicated (VAI)3002806753
May 17, 2016Holly Springs, NCBiologicsVoluntary Action Indicated (VAI)3007867647
Jun 13, 2014Parkville, AustraliaBiologicsVoluntary Action Indicated (VAI)3002806753
Nov 21, 2013Holly Springs, NCDrugsNo Action Indicated (NAI)3007867647
Apr 24, 2012Parkville, AustraliaBiologicsVoluntary Action Indicated (VAI)3002806753
Apr 28, 2010Parkville, AustraliaBiologicsVoluntary Action Indicated (VAI)3002806753
Apr 23, 2009Parkville, AustraliaBiologicsVoluntary Action Indicated (VAI)3002806753

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 3007867647Holly Springs, NC5Jun 5, 2025
FEI 3002806753Parkville, Australia5Aug 16, 2016

FDA data resources

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