Wisconsin Diagnostic Laboratories, LLC

FDA Regulatory Profile

Wisconsin Diagnostic Laboratories, LLC has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 25, 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
Inspections8Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 25, 2025Milwaukee, WIBiologicsVoluntary Action Indicated (VAI)2171821
Aug 18, 2022Milwaukee, WIBiologicsNo Action Indicated (NAI)2171821
May 18, 2017Milwaukee, WIBiologicsNo Action Indicated (NAI)2171821
Jan 13, 2017Milwaukee, WIBiologicsNo Action Indicated (NAI)2171821
Jan 29, 2015Milwaukee, WIBiologicsVoluntary Action Indicated (VAI)2171821
Dec 26, 2012Milwaukee, WIBiologicsNo Action Indicated (NAI)2171821
Dec 22, 2010Milwaukee, WIBiologicsVoluntary Action Indicated (VAI)2171821
May 13, 2009Milwaukee, WIBiologicsNo Action Indicated (NAI)2171821

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 2171821Milwaukee, WI8Jun 25, 2025

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