BeOne Medicines USA, Inc.February 17, 2026

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

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Record Details

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.

Company: BeOne Medicines USA, Inc.
Inspection Date: February 17, 2026
Product Type: Drugs
Office: New Jersey District Office
Person: Jay B. Shah (Investigator)

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ID · a09a8566-d36b-488c-bae3-e404c80e4662