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Ascension Seton

FDA Regulatory Profile

Ascension Seton has 0 FDA recalls, 15 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jul 25, 2025 · NAI

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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
Inspections15Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jul 25, 2025Austin, TXBiologicsNo Action Indicated (NAI)3006775936
Jul 22, 2025Austin, TXBiologicsNo Action Indicated (NAI)1000059490
Jul 27, 2022Austin, TXBiologicsNo Action Indicated (NAI)1000059490
Mar 11, 2022Austin, TXBiologicsNo Action Indicated (NAI)3006775936
Jun 15, 2018Austin, TXBiologicsNo Action Indicated (NAI)1000059490
Jun 8, 2018Austin, TXBiologicsNo Action Indicated (NAI)3006775936
Mar 21, 2016Austin, TXBiologicsNo Action Indicated (NAI)1000059490
Jan 20, 2016Austin, TXBiologicsNo Action Indicated (NAI)3006775936
Jul 23, 2014Austin, TXBiologicsNo Action Indicated (NAI)3006775936
Jan 30, 2014Austin, TXBiologicsNo Action Indicated (NAI)1000059490
Oct 11, 2012Austin, TXBiologicsNo Action Indicated (NAI)3006775936
Feb 1, 2012Austin, TXBiologicsNo Action Indicated (NAI)1000059490
Dec 6, 2010Austin, TXBiologicsNo Action Indicated (NAI)3006775936
Jan 12, 2010Austin, TXBiologicsNo Action Indicated (NAI)1000059490
Feb 5, 2009Austin, TXBiologicsNo Action Indicated (NAI)3006775936

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 3006775936Austin, TX8Jul 25, 2025
FEI 1000059490Austin, TX7Jul 22, 2025

FDA data resources

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