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Aurorium LLC

FDA Regulatory Profile

Aurorium LLC has 0 FDA recalls, 15 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Mar 6, 2026 · 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
Inspections15Nov 10, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 6, 2026Midlothian, TXDrugsVoluntary Action Indicated (VAI)1628757
Jul 31, 2025Zeeland, MIDrugsVoluntary Action Indicated (VAI)1824624
May 11, 2023Zeeland, MIFood/CosmeticsNo Action Indicated (NAI)1824624
Apr 9, 2019Zeeland, MIDrugsVoluntary Action Indicated (VAI)1824624
May 14, 2018Midlothian, TXDrugsVoluntary Action Indicated (VAI)1628757
Feb 28, 2017Zeeland, MIFood/CosmeticsNo Action Indicated (NAI)1824624
Aug 5, 2016Midlothian, TXVeterinaryVoluntary Action Indicated (VAI)1628757
Jul 11, 2014Zeeland, MIDrugsVoluntary Action Indicated (VAI)1824624
Dec 20, 2012Midlothian, TXDrugsNo Action Indicated (NAI)1628757
Nov 21, 2012Greensboro, NCFood/CosmeticsNo Action Indicated (NAI)3002906664
Oct 29, 2012Zeeland, MIFood/CosmeticsNo Action Indicated (NAI)1824624
Jun 15, 2012Zeeland, MIDrugsVoluntary Action Indicated (VAI)1824624
Jun 21, 2011Zeeland, MIDrugsVoluntary Action Indicated (VAI)1824624
Aug 27, 2010Zeeland, MIDrugsVoluntary Action Indicated (VAI)1824624
Jun 7, 2010Midlothian, TXDrugsNo Action Indicated (NAI)1628757

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 1628757Midlothian, TX5Mar 6, 2026
FEI 1824624Zeeland, MI9Jul 31, 2025
FEI 3002906664Greensboro, NC1Nov 21, 2012

FDA data resources

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