FDA 483 - Hebei Jingye Medical Technology Corp., LTD. - June 28, 2024

Hebei Jingye Medical Technology Co., Ltd. in Cangzhou, China, an API manufacturer, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included failures in change control management, supplier qualification, equipment maintenance, and timely record-keeping. These issues indicate a lack of adherence to established procedures and a potential impact on API quality.