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SEAGEN INC.

FDA Regulatory Profile

SEAGEN INC. has 0 FDA recalls, 11 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 13, 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
Inspections11Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 13, 2025Bothell, WADrugsVoluntary Action Indicated (VAI)3002781621
Nov 1, 2024Bothell, WADrugsNo Action Indicated (NAI)3002781621
May 2, 2024Bothell, WADrugsNo Action Indicated (NAI)3002781621
Jan 24, 2020Bothell, WADrugsNo Action Indicated (NAI)3002781621
Oct 4, 2019Bothell, WADrugsNo Action Indicated (NAI)3002781621
Jan 5, 2018Bothell, WADrugsNo Action Indicated (NAI)3002781621
May 1, 2017Bothell, WADrugsVoluntary Action Indicated (VAI)3002781621
Jun 9, 2015Bothell, WADrugsVoluntary Action Indicated (VAI)3002781621
Mar 20, 2013Bothell, WADrugsVoluntary Action Indicated (VAI)3002781621
Jul 19, 2011Bothell, WADrugsVoluntary Action Indicated (VAI)3002781621
May 19, 2011Bothell, WADrugsVoluntary Action Indicated (VAI)3002781621

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.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3002781621Bothell, WA11May 13, 2025

FDA data resources

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