FDA WARNING_LETTER - Luis Javier Pena-Hernandez, M.D., FCCP - January 23, 2023

An FDA inspection conducted from January 9 to January 23, 2023, at Dr. Pena-Hernandez's clinical site revealed objectionable conditions regarding the conduct of clinical investigation Protocol (b)(4) for investigational drug products (b)(4). The inspection, part of FDA’s Bioresearch Monitoring Program, identified failures to adhere to statutory requirements in the FD&C Act and 21 CFR 312. Specifically, Dr. Pena-Hernandez failed to ensure the investigation was conducted according to the investigational plan (21 CFR 312.60), by enrolling a subject who did not meet the required inclusion criterion of being on a specific medication. Additionally, the investigator failed to ensure an Institutional Review Board (IRB) complied with 21 CFR part 56 for continuing review and approval (21 CFR 312.66), as IRB approval for the protocol lapsed from December 3, 2021, to January 27, 2022, during which study procedures were performed. These deficiencies raise significant concerns about subject safety, welfare, and the validity and integrity of the data collected. The FDA noted systemic failures and an inadequate response regarding corrective actions. Dr. Pena-Hernandez is required to notify the FDA in writing within 15 business days of receipt of the letter, detailing actions taken to prevent future violations, including a comprehensive corrective action plan and new policies for oversight and protocol compliance. Failure to adequately address these issues may result in further regulatory action.