FDA 483 - Wanzhu Hou, CMD, MD (CN) - March 17, 2022

Wanzhu Hou, CMD, MD (CN) in Rockville, MD, a sponsor-investigator, was cited for significant non-compliance during an inspection of their clinical studies. The firm failed to submit an IND, ensure IRB review and approval, obtain informed consent, maintain adequate case histories, and keep proper investigational drug disposition records. These issues indicate a broad failure to adhere to regulations governing clinical investigations.