FDA 483 - Alvin C. Silva, MD - December 05, 2025

Alvin C. Silva, MD, a clinical investigator in Phoenix, AZ, received a Form 483 citing three observations during an FDA inspection. The firm failed to conduct an investigation in accordance with the investigational plan, specifically regarding the delayed reporting of a serious adverse event. Additionally, issues were found with maintaining adequate and accurate case histories, including data discrepancies and unclear adverse event reporting, and informed consent was not properly documented.