FDA 483 - JIANGSU GRAND XIANLE PHARMACEUTICAL CO., LTD

An FDA inspection of JIANGSU GRAND XIANLE PHARMACEUTICAL CO., LTD identified a significant deficiency related to the lack of adequate stability data for a critical intermediate material. The firm failed to provide sufficient data to support the retest date, with initial stability studies failing specifications and subsequent studies being unrepresentative or conducted prior to analytical method validation. This indicates a serious lapse in quality control and data integrity practices.