FDA 483 - Huilai Zhang, MD - February 21, 2025

An FDA Form 483 was issued to Tianjin Medical University Cancer Hospital, a clinical investigator site located in Tianjin, China, following an inspection conducted from July 20-22, 2021. The inspection observed deviations from regulatory expectations, specifically regarding the adherence to the investigational plan and protocol. The primary issue identified was the failure to consistently follow the established study protocol, particularly concerning the reporting and documentation of adverse events. Observations noted that adverse events were not entered into the Electronic Case Report Form (ECRF) in a timely manner or as required by the study protocol for multiple subjects. For instance, adverse events were discovered and subsequently entered into the ECRF with significant delays or were not entered at all, despite being reported. This indicates a lapse in maintaining accurate and complete study records essential for patient safety oversight and data integrity. This document serves as an official communication of inspectional observations, highlighting areas where the clinical investigator did not meet the expected standards for conducting clinical research. While the FDA 483 does not dictate specific corrective actions, the hospital is expected to promptly address these observations by implementing robust corrective and preventive actions to ensure full compliance with the investigational plan and applicable regulations for clinical trials.