FDA 483 - Zhejiang Jiuzhou Pharmaceutical Co., Ltd. - September 10, 2018
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An FDA inspection of Zhejiang Jiuzhou Pharmaceutical Co., Ltd. in Taizhou, Zhejiang, an API manufacturer, identified a significant deficiency in process validation. The firm's validation report for an active pharmaceutical ingredient failed to address instances where the upper confidence limits for unknown impurities and residual solvents exceeded specification limits in both intermediate and finished batches. This indicates a lack of adequate control over manufacturing processes and product quality.
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