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Chemolee Lab Corporation

FDA Regulatory Profile

Chemolee Lab Corporation has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
May 30, 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
Inspections7Nov 11, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 30, 2025Irving, TXDrugsVoluntary Action Indicated (VAI)1642813
Feb 10, 2020Irving, TXDrugsNo Action Indicated (NAI)1642813
May 18, 2017Irving, TXDrugsVoluntary Action Indicated (VAI)1642813
Feb 13, 2015Irving, TXDrugsOfficial Action Indicated (OAI)1642813
Jul 18, 2013Irving, TXDrugsVoluntary Action Indicated (VAI)1642813
Sep 1, 2011Irving, TXDrugsOfficial Action Indicated (OAI)1642813
Dec 21, 2009Irving, TXDrugsVoluntary Action Indicated (VAI)1642813

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 1642813Irving, TX7May 30, 2025

FDA data resources

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