# FDA 483 - BeiGene, USA Inc. - November 13, 2023

Source: https://www.keypedia.com/records/483/beigene-usa-inc/0d8dd877-90c5-40b1-aa87-1692e33099a5

> FDA 483 for BeiGene, USA Inc. on November 13, 2023. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: BeiGene, USA Inc.
- Inspection Date: 2023-11-13
- Product Type: Drugs
- Office Name: San Francisco District Office
- Summary: An FDA inspection of BeiGene USA Inc. conducted from October 30 to November 13, 2023, identified significant issues in adverse event reporting and clinical study management. The inspection, which covered both Sponsor and Post-Approval Drug Experience (PADE) activities, resulted in three primary observations.

Firstly, BeiGene USA Inc. failed to report eight serious and unexpected adverse drug experiences to the FDA within the required 15 calendar days. These delays varied significantly, with some reports submitted up to 239 days late. Secondly, the company lacked formal written procedures for surveilling and reporting adverse events identified through social media platforms, including Twitter and LinkedIn.

Lastly, the inspection revealed inadequate monitoring of a clinical study. Numerous safety events with serious outcomes were not promptly reported to Institutional Review Boards/Ethics Committees, and some lacked crucial information regarding their source or investigation. Furthermore, over 2,000 clinical data queries experienced lengthy resolution times, with some taking years to close. The Standard Operating Procedure for query resolution was deemed insufficient due to the absence of specified timelines. These findings indicate a need for BeiGene USA Inc. to enhance its compliance with FDA regulations governing pharmacovigilance and clinical trial oversight by implementing corrective actions.

## Related Documents

- [483 - 2023-11-13](https://www.keypedia.com/records/483/beigene-usa-inc/9c8f2383-af4e-4b58-b663-779863e3ef9c)

## Related Officers

- [Scott N. Lim](https://www.keypedia.com/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)

Company: https://www.keypedia.com/companies/beigene-usa-inc/4aa7a574-c42e-4523-9af7-37a954652780

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df