FDA Inspection 1303410 — BeOne Medicines USA, Inc.

BeOne Medicines USA, Inc. — FEI 3028672933

The FDA completed an inspection of BeOne Medicines USA, Inc. on February 17, 2026 in Pennington, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 17, 2026
Fiscal Year
2026
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Pennington, NJ (United States)

Additional Details

Sponsor, Contract Research Organization

Citations

IDCFRDescription
748221 CFR 312.50General responsibilities of sponsors