FDA 483 - Pedro A. Velasquez-Mieyer, M.D. - September 13, 2024

During an inspection conducted from September 9-13, 2024, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Pedro A. Velasquez-Mieyer, M.D. The inspection, which focused on a clinical research study titled (b)(4), identified a significant observation: the investigation was not conducted in accordance with the established investigational plan. Specifically, the firm failed to adequately assess critical enrollment criteria for multiple subjects. For two of the seven enrolled subjects, there was insufficient documentation to verify fasting (b)(4) measurements, an essential component of exclusion criterion #3. This meant these subjects were randomized and received investigational product without proper eligibility confirmation. Furthermore, two other enrolled subjects met exclusion criterion #17, which prohibits current use of anticonvulsant medication. Despite this, these subjects were also randomized and treated with the investigational product. These findings indicate a deviation from regulatory expectations for clinical trial conduct. The company is required to review these observations and implement appropriate corrective actions to ensure future compliance with study protocols and FDA regulations.