United Laboratories Manufacturing, LLC

FDA Regulatory Profile

United Laboratories Manufacturing, LLC has 0 FDA recalls, 11 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 15, 2025 · 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
Inspections11Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 15, 2025Carrollton, TXDrugsVoluntary Action Indicated (VAI)3006056935
Mar 7, 2025Carrollton, TXFood/CosmeticsNo Action Indicated (NAI)3006056935
May 9, 2023Carrollton, TXFood/CosmeticsNo Action Indicated (NAI)3006056935
Aug 31, 2018Dallas, TXFood/CosmeticsNo Action Indicated (NAI)1000220470
Apr 9, 2018Carrollton, TXDrugsVoluntary Action Indicated (VAI)3006056935
Dec 14, 2017Dallas, TXDrugsVoluntary Action Indicated (VAI)1000220470
Aug 26, 2016Carrollton, TXDrugsVoluntary Action Indicated (VAI)3006056935
Apr 22, 2013Dallas, TXDrugsVoluntary Action Indicated (VAI)1000220470
Aug 16, 2012Carrollton, TXFood/CosmeticsVoluntary Action Indicated (VAI)3006056935
Jul 17, 2012Dallas, TXDrugsVoluntary Action Indicated (VAI)1000220470
Aug 12, 2010Carrollton, TXDrugsVoluntary Action Indicated (VAI)3006056935

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 3006056935Carrollton, TX7Aug 15, 2025
FEI 1000220470Dallas, TX4Aug 31, 2018

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