John J. Wrenn, M.D. – FDA 483, Apr 15, 2024

During an FDA inspection conducted from April 3 to April 15, 2024, at John J. Wrenn, M.D., a clinical investigator facility, several significant observations were noted regarding the conduct of clinical research studies. The inspection revealed that investigations were not consistently managed according to signed investigator statements and investigational plans, indicating a lack of proper oversight. Specifically, for one protocol, the master accountability log for investigational product was incomplete, failing to account for drug receipt, dispensing, or returns over a substantial period (January 2019 to October 2020). Furthermore, the facility was unable to provide essential regulatory documents, study data, and relevant correspondence for another protocol during the inspection, violating requirements for direct access to source data. A second major observation concerned inadequate investigational drug disposition records. Individual subject accountability logs for an investigational product were either missing or contained incomplete information regarding dispensed and returned medication bottles across multiple subjects. These omissions prevent proper verification of treatment compliance and drug usage. These observations highlight deficiencies in adherence to study protocols and regulatory expectations for clinical investigators. John J. Wrenn, M.D., is required to address these issues by implementing corrective actions to ensure proper oversight, comprehensive record-keeping, and accurate accountability for investigational products in future and ongoing studies. The FDA 483 serves as a formal notification of these conditions, necessitating a response and resolution from the firm.