# FDA 483 - BeOne Medicines USA, Inc. - February 17, 2026

Source: https://www.keypedia.com/records/483/beone-medicines-usa-inc/a09a8566-d36b-488c-bae3-e404c80e4662

> FDA 483 for BeOne Medicines USA, Inc. on February 17, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BeOne Medicines USA, Inc.
- Inspection Date: 2026-02-17
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of BeOne Medicines USA, Inc. in Pennington, NJ, revealed a significant failure to adhere to clinical study protocols. The firm enrolled a subject into a study without required hepatitis C screening and failed to obtain necessary consent for a tumor biopsy, leading to the biopsy not being shipped for pathology confirmation. These issues highlight critical deviations in the conduct of clinical trials and subject protection.

## Related Officers

- [Investigator](https://www.keypedia.com/people/jay-b-shah/c437fff9-807e-4dea-80c0-8f77850db6f8)

Company: https://www.keypedia.com/companies/beone-medicines-usa-inc/c0db89d5-6a53-40bc-8d3f-3c603e17a11d

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248