FDA 483 - Kai Huang - May 16, 2025

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.