FDA 483 - Zennova Pharmaceuticals (chengdu) Co.,ltd. - March 21, 2025

Zennova Pharmaceuticals (Chengdu) Co.,Ltd., a drug manufacturer, was cited for failing to establish adequate written procedures for production and process controls. This deficiency led to out-of-specification impurity levels in drug products following a packaging configuration change, with the root cause attributed to the container closure system. The firm did not adequately assess the impact of this change on product quality.