FDA 483 - Shlomo Pascal, M.D. - July 06, 2021

Shlomo Pascal, M.D. in Miami, FL, was issued a Form 483 with two observations following an FDA inspection. The firm failed to maintain adequate and accurate case histories, including the destruction of original paper source records for clinical trial subjects. Additionally, the investigation was not conducted in accordance with the investigational plan, with failures in completing study procedures and ensuring subject safety through proper re-consent.