FDA 483 - Joel Solis, MD - September 08, 2023

An FDA inspection of Joel L. Solis, MD, Clinical Investigator in McAllen, TX, revealed a significant deviation from clinical investigation protocols. The firm failed to conduct an investigation in accordance with the signed statement of investigator and investigational plan. This was evidenced by 55 subject records showing missed safety calls, in-person visits, and eDiary entries as required by the study protocol.