# FDA 483 - Qun Xia - February 20, 2025

Source: https://www.keypedia.com/records/483/qun-xia/1fd209e9-6006-4789-9b65-5b2088b965a1

> FDA 483 for Qun Xia on February 20, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Qun Xia
- Inspection Date: 2025-02-20
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Qun Xia, Chief Physician, identified a significant failure in protecting human subjects during a clinical investigation. The site failed to obtain proper informed consent from four subjects who continued participation in a study, including receiving study-related procedures and assessments, despite refusing to sign an amended consent form. This lapse indicates a serious disregard for subject rights and safety.

## Related Officers

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

Company: https://www.keypedia.com/companies/qun-xia/7ab7005f-2825-40c2-905b-cb6fb375e91a

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8