FDA WARNING_LETTER - Evelyn Lopez-Brignoni, M.D. - June 23, 2020

The FDA conducted an inspection at Dr. Lopez-Brignoni's clinical site from June 8 to June 23, 2020, as part of its Bioresearch Monitoring Program, reviewing clinical investigations for Protocols (b)(4) and (b)(4). The inspection revealed objectionable conditions, leading to a Form FDA 483. Following a review of the site's July 7, 2020, response, the FDA concluded that the clinical investigator failed to adhere to applicable statutory requirements and FDA regulations governing clinical investigations. The primary violation identified was the failure to ensure the investigation was conducted according to the investigational plan, as required by 21 CFR 312.60. Specifically, subjects in both Protocols (b)(4) and (b)(4) received less than the required dose of study medication. This inadequate dosing, attributed by the site to unclear protocol language and insufficient training, raises significant concerns about the validity and integrity of the collected data and the rights, safety, and welfare of the vulnerable pediatric subjects. While the FDA acknowledged the site's implemented corrective actions, including enhanced staff training, documentation of sponsor communications, and quality control oversight, it requested that Dr. Lopez-Brignoni, as the clinical investigator, provide specific corrective actions taken to prevent similar violations. A written response detailing these actions is required within fifteen working days to avoid potential regulatory action. The letter emphasizes the ongoing responsibility to ensure compliance with FDA regulations for all current and future studies.