# FDA 483 - Lixin Zhang, M.D. - December 19, 2025

Source: https://www.keypedia.com/records/483/lixin-zhang-md/0c6a9901-9968-4924-ae1a-aa298c7b1c09

> FDA 483 for Lixin Zhang, M.D. on December 19, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lixin Zhang, M.D.
- Inspection Date: 2025-12-19
- Product Type: drugs
- Office Name: New York District Office
- Summary: An FDA inspection of Dent Neurosciences Research Center, a clinical investigator in Amherst, NY, revealed significant issues with the conduct of an investigation. The firm failed to follow the investigational plan, specifically regarding data integrity in an eCOA system where a common password allowed a subject to access staff accounts and enter data. Additionally, the site dispensed an incorrect dose formulation of investigational product to a subject.

## Related Officers

- [investigator](https://www.keypedia.com/people/benton-m-ketron/34d763d8-4374-4c8b-8dd6-dce1a83dcd01)

Company: https://www.keypedia.com/companies/lixin-zhang-md/26431f1a-9655-46af-b366-759e679af56c

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d