FDA 483 - Javier Sosa Faria, M.D. - October 31, 2025

An FDA inspection of Javier Sosa Faria, M.D. in Ponce, PR, revealed significant deficiencies in the conduct of clinical investigations. The firm failed to adhere to its investigational plan, properly follow up on adverse events, and ensure adequate staff training. Additionally, issues were noted regarding the obtaining of legally effective informed consent and the provision of consent form copies to subjects.