FDA 483 - Lily C. Chao, M.D. - September 25, 2025

The FDA issued a Form 483 to Lily C. Chao, M.D., a clinical investigator in Los Angeles, CA, following an inspection. Observations included failures to conduct an investigation in accordance with the investigational plan, specifically regarding updated informed consent and documented physician reviews. Additionally, the firm failed to maintain adequate and accurate case histories by not reporting adverse events and concomitant medications to the Sponsor.