# FDA 483 - Kai Huang - May 16, 2025

Source: https://www.globalkeysolutions.net/records/483/kai-huang/f11045d7-21b0-4e55-9c7a-15b82057df9f

> FDA 483 for Kai Huang on May 16, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kai Huang
- Inspection Date: 2025-05-16
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Kai Huang, a Clinical Investigator in Wuxi, China, was cited for two significant observations during an FDA inspection. The inspection revealed failures in performing a clinical study according to good clinical practices, including unauthorized extended subject housing during COVID-19 lockdowns and inadequate documentation. Additionally, the firm failed to meet general informed consent requirements, notably involving a subject's partner being pressured to terminate a pregnancy.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/jennifer-c-adams/85608566-bd13-41d8-b86e-cc9111c7dfe5)

Company: https://www.globalkeysolutions.net/companies/kai-huang/41ce4c2a-9a21-4f39-88e6-9df60e110c04

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