FDA 483 - Joinn Laboratories Co., Ltd. - September 20, 2013

An FDA inspection conducted at Joinn Laboratories Co., Ltd. in Beijing, China, from September 16-20, 2013, identified significant observations regarding the firm's adherence to Good Laboratory Practice (GLP) regulations. The inspection, focusing on their GLP facility, revealed multiple deficiencies impacting data integrity and study oversight. Key issues included the Quality Assurance Unit's failure to verify that final study reports accurately reflected raw data, citing discrepancies in animal body weight changes and toxicokinetic assay dates. Furthermore, the study director did not consistently ensure that approved protocols were followed, as evidenced by the lack of documented deviations for delayed report receipt and un-retained reserve samples. Critical study records, such as external and internal correspondences, were also not consistently transferred to archives at the study's conclusion. A particularly concerning observation highlighted inaccurate experimental data recording, where a dosing record indicated treatment for an animal that had already deceased. These observations underscore a need for improved quality systems and stricter adherence to GLP principles to ensure the reliability and integrity of non-clinical laboratory studies. While an FDA Form 483 lists observations and not final determinations, the firm is expected to address these findings and implement comprehensive corrective actions to resolve the identified compliance issues.