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Sirtex Wilmington LLC

FDA Regulatory Profile

Sirtex Wilmington LLC has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 10, 2025 · VAI

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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
Inspections4Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 10, 2025Wilmington, MADevicesVoluntary Action Indicated (VAI)3005579300
Jul 12, 2013Wilmington, MADevicesVoluntary Action Indicated (VAI)3005579300
May 10, 2011Wilmington, MADevicesNo Action Indicated (NAI)3005579300
Jan 30, 2009Wilmington, MADevicesVoluntary Action Indicated (VAI)3005579300

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 3005579300Wilmington, MA4Jul 10, 2025

FDA data resources

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