FDA WARNING_LETTER - Ignacio J. Rodriguez, MD - September 29, 2020

An FDA inspection conducted between August 18 and September 29, 2020, at Dr. Rodriguez's clinical site revealed objectionable conditions regarding the conduct of a clinical investigation (b)(4). The inspection, part of the Bioresearch Monitoring Program, found that the site failed to adhere to applicable statutory requirements and FDA regulations for clinical investigations and human subject protection. Specifically, Dr. Rodriguez failed to ensure the investigation was conducted according to the investigational plan, as required by 21 CFR 312.60. This included failures to exclude ineligible subjects based on protocol-defined conditions, ensure subjects met randomization criteria before randomization, and complete required study activities, such as obtaining necessary (b)(4) or confirmation from the Central Reader before study drug administration. While some corrective actions, like a Clinical Quality Management Plan and staff re-education, were deemed potentially adequate for certain violations, the response regarding ineligible subjects lacked sufficient detail on preventing future protocol violations and ensuring adequate personal oversight. These deficiencies jeopardized subject safety and welfare, raising concerns about data validity. The FDA requires a written response within 15 days detailing actions taken to prevent future violations, warning that failure to adequately address these issues may lead to regulatory action.