FDA WARNING_LETTER - Angela M. Stupi, M.D. - September 29, 2022

An FDA inspection conducted from September 1 to September 29, 2022, at Dr. Stupi's clinical site, revealed objectionable conditions regarding the conduct of clinical investigations for (b)(4). The inspection, part of FDA’s Bioresearch Monitoring Program, found that Dr. Stupi failed to adhere to applicable statutory requirements in the FD&C Act and 21 CFR 312, governing clinical investigations and human subject protection. Key violations included failure to ensure the investigation was conducted according to the investigational plan [21 CFR 312.60]. Specifically, for Protocol (b)(4), a subject was enrolled without meeting the required stimulated whole salivary flow rate. For Protocol (b)(4), two subjects were enrolled without documented radiologic evidence fulfilling Modified New York criteria. Additionally, for Protocol (b)(4), study drug was administered in forearms instead of protocol-specified locations. The FDA deemed Dr. Stupi's October 4, 2022, response inadequate, lacking sufficient details on corrective actions, policies, procedures, and staff training. These failures raise significant concerns about subject safety and data integrity. Dr. Stupi is required to notify the FDA in writing within 15 business days of receipt of the letter, detailing actions taken to prevent similar violations, or face potential regulatory action.