# FDA 483 - Huiqiang Sun Huang - February 14, 2025

Source: https://www.keypedia.com/records/483/huiqiang-sun-huang/e12f0a35-ccdf-4b6b-82ab-1eb5fb398442

> FDA 483 for Huiqiang Sun Huang on February 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Huiqiang Sun Huang
- Inspection Date: 2025-02-14
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Yet-Sen University Cancer Center's clinical research facility in Guangzhou, China, revealed significant deviations from its investigational plan. Deficiencies included inadequate subject file documentation, improper study drug handling and storage, and insufficient staff training in Good Clinical Practice. These findings indicate a systemic failure to adhere to proper clinical trial procedures, potentially impacting subject safety and data integrity.

## Related Documents

- [483 - 2025-02-14](https://www.keypedia.com/records/483/huiqiang-sun-huang/48f74644-7fa9-4738-81e2-0dc8ac5cfe66)

## Related Officers

- [Janete F. Guardia](https://www.keypedia.com/people/janete-f-guardia/2405f83f-7ea9-4056-afbd-7d9c00a6e169)
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Company: https://www.keypedia.com/companies/huiqiang-sun-huang/3c49cc1b-7120-4374-b392-486dbef558db

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