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Trace Elements, Inc

FDA Regulatory Profile

Trace Elements, Inc has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 11, 2024 · 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 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 11, 2024Addison, TXFood/CosmeticsVoluntary Action Indicated (VAI)3004674604
Sep 30, 2021Addison, TXFood/CosmeticsVoluntary Action Indicated (VAI)3004674604
Apr 6, 2017Addison, TXFood/CosmeticsNo Action Indicated (NAI)3004674604
Jan 19, 2016Addison, TXFood/CosmeticsOfficial Action Indicated (OAI)3004674604

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 3004674604Addison, TX4Jun 11, 2024

FDA data resources

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