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BeOne Medicines USA, Inc.

FDA Regulatory Profile

BeOne Medicines USA, Inc. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 17, 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 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 17, 2026Pennington, NJDrugsVoluntary Action Indicated (VAI)3028672933
Nov 6, 2025Pennington, NJDrugsNo Action Indicated (NAI)3028672933
Nov 13, 2023San Carlos, CADrugsVoluntary Action Indicated (VAI)3022883614

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 3028672933Pennington, NJ2Feb 17, 2026
FEI 3022883614San Carlos, CA1Nov 13, 2023

FDA data resources

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