FDA 483 - Joinn Laboratories Co., Ltd.

An FDA inspection of Joinn Laboratories Co., Ltd. in Beijing, China, a Good Laboratory Practice facility, revealed significant deficiencies in quality assurance, study protocol adherence, and data management. Observations included failures to accurately reflect raw data in final reports, ensure protocol approval and follow-through, and properly archive study records. These issues indicate a lack of robust controls over the integrity and reliability of study data.