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Westlake IVF, LLC

FDA Regulatory Profile

Westlake IVF, LLC has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Dec 11, 2023 · 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
Inspections5Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 11, 2023Austin, TXBiologicsVoluntary Action Indicated (VAI)3009085684
Apr 1, 2021Austin, TXBiologicsVoluntary Action Indicated (VAI)3009085684
May 31, 2019Austin, TXBiologicsOfficial Action Indicated (OAI)3009085684
Mar 31, 2015Austin, TXBiologicsVoluntary Action Indicated (VAI)3009085684
Jul 5, 2012Austin, TXBiologicsVoluntary Action Indicated (VAI)3009085684

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 3009085684Austin, TX5Dec 11, 2023

FDA data resources

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