FDA 483 - Zhejiang Chinese Medical University - November 13, 2024

An FDA inspection of Zhejiang Chinese Medical University, a contract testing laboratory in Hangzhou, China, revealed significant deficiencies in its quality control unit and computer system controls. The quality control unit failed to oversee critical records and approve procedures, while the computerized pyrogen testing system lacked appropriate controls, allowing the Technical Manager to delete samples and test records. These issues indicate a lack of robust quality management and potential data integrity risks.