FDA 483 - Joinn Laboratories Co. Ltd. - September 16, 2013

An FDA inspection conducted at Joinn Laboratories Co., Ltd. in Beijing, China, from September 16-20, 2013, identified significant observations regarding compliance with Good Laboratory Practice (GLP) standards. The report, issued to Facility Manager Dr. Yunxia Sun, highlighted critical failures in quality assurance and study management. Key issues included the Quality Assurance Unit's failure to ensure final study reports accurately reflected raw data, specifically noting discrepancies in animal body weight changes and toxicokinetic assay dates. Furthermore, the study director did not consistently ensure adherence to approved protocols, as evidenced by the absence of documented deviations for delayed toxicokinetic report receipt and the failure to retain reserve control samples. The inspection also found that the study director failed to ensure the proper archiving of all study records, including essential external and internal correspondences. A notable observation was the inaccurate recording of experimental data, with a dosing record indicating treatment for an animal that had already died. These observations suggest a need for Joinn Laboratories Co., Ltd. to implement comprehensive corrective actions to address the identified deficiencies in their GLP systems and ensure data integrity and protocol compliance.