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Formulife, LLC

FDA Regulatory Profile

Formulife, LLC has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 3 compliance actions on record.

Latest inspection
Aug 12, 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
Inspections9Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions3Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 12, 2025Mckinney, TXFood/CosmeticsNo Action Indicated (NAI)3025065421
Dec 9, 2024Allen, TXFood/CosmeticsVoluntary Action Indicated (VAI)3007844828
Jan 30, 2023Allen, TXFood/CosmeticsVoluntary Action Indicated (VAI)3007844828
Dec 1, 2017Allen, TXFood/CosmeticsVoluntary Action Indicated (VAI)3007844828
Jul 22, 2016Allen, TXFood/CosmeticsOfficial Action Indicated (OAI)3007844828
Jul 23, 2015Allen, TXFood/CosmeticsVoluntary Action Indicated (VAI)3007844828
Feb 7, 2014Allen, TXFood/CosmeticsOfficial Action Indicated (OAI)3007844828
Sep 11, 2012Allen, TXFood/CosmeticsOfficial Action Indicated (OAI)3007844828
May 19, 2011Allen, TXFood/CosmeticsOfficial Action Indicated (OAI)3007844828

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 3025065421Mckinney, TX1Aug 12, 2025
FEI 3007844828Allen, TX8Dec 9, 2024

FDA data resources

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