FDA 483 - Joinn Laboratories Co. Ltd. - May 21, 2024

An FDA inspection of Joinn Laboratories Co. Ltd., a nonclinical laboratory in Beijing, China, was conducted from May 13 to May 21, 2024. The inspection resulted in a Form FDA 483, identifying two significant observations regarding quality system compliance. The first observation indicated that equipment used for data generation and assessment was not adequately tested, calibrated, or standardized. Specifically, a BD Cytometric Bead Array Cytokine Assay used for analyzing cynomolgus monkey serum in study P23-169-RD had not been validated, raising concerns about data reliability. The second observation highlighted the quality assurance unit's failure to identify unauthorized or undocumented deviations from approved study protocols. An instance cited was the omission of an external examination during the gross necropsy of a control animal in study P23-228-RD, despite protocol requirements. These observations underscore critical areas where Joinn Laboratories Co. Ltd. must implement corrective actions to ensure the integrity of its nonclinical studies and adhere to regulatory expectations. The company is required to provide a formal response to the FDA addressing these findings.