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Sovereign Pharmaceuticals, LLC

FDA Regulatory Profile

Sovereign Pharmaceuticals, LLC has 0 FDA recalls, 14 inspections, 0 510(k) clearances and 2 compliance actions on record.

Latest inspection
May 12, 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
Inspections14Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions2Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
May 12, 2025Fort Worth, TXDrugsVoluntary Action Indicated (VAI)3003229412
Aug 2, 2023Fort Worth, TXDrugsOfficial Action Indicated (OAI)3003229412
Apr 22, 2022Fort Worth, TXDrugsOfficial Action Indicated (OAI)3003229412
Sep 1, 2021Fort Worth, TXDrugsVoluntary Action Indicated (VAI)3003229412
Dec 12, 2019Fort Worth, TXDrugsVoluntary Action Indicated (VAI)3003229412
Dec 19, 2018Fort Worth, TXDrugsNo Action Indicated (NAI)3003229412
Jan 12, 2018Fort Worth, TXDrugsVoluntary Action Indicated (VAI)3003229412
Nov 10, 2016Fort Worth, TXDrugsVoluntary Action Indicated (VAI)3003229412
Jan 8, 2016Fort Worth, TXDrugsVoluntary Action Indicated (VAI)3003229412
Aug 21, 2015Fort Worth, TXDrugsVoluntary Action Indicated (VAI)3003229412
Jun 21, 2013Fort Worth, TXDrugsNo Action Indicated (NAI)3003229412
Feb 2, 2012Fort Worth, TXDrugsOfficial Action Indicated (OAI)3003229412
May 24, 2010Fort Worth, TXDrugsVoluntary Action Indicated (VAI)3003229412
Jun 17, 2009Fort Worth, TXDrugsVoluntary Action Indicated (VAI)3003229412

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 3003229412Fort Worth, TX14May 12, 2025

FDA data resources

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