483
Zennova Pharmaceuticals (chengdu) Co.,ltd.Zennova Pharmaceuticals (chengdu) Co.,ltd. – FDA 483, Mar 21, 2025
Record Details
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.
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