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Benuvia Operations, LLC

FDA Regulatory Profile

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

Latest inspection
Jan 23, 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
Inspections3Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 23, 2026Round Rock, TXDrugsVoluntary Action Indicated (VAI)3011419064
Sep 20, 2021Round Rock, TXDrugsNo Action Indicated (NAI)3011419064
Sep 12, 2017Round Rock, TXDrugsVoluntary Action Indicated (VAI)3011419064

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 3011419064Round Rock, TX3Jan 23, 2026

FDA data resources

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