FDA 483 - Zhejiang Jiuzhou Pharmaceutical Co., Ltd. - September 13, 2018

Zhejiang Jiuzhou Pharmaceutical Co., Ltd. received an FDA Form 483 following an inspection conducted from September 10-13, 2018. The inspection, carried out at their API manufacturing facility in Taizhou, Zhejiang, PRC, identified a significant observation related to process validation. The primary issue noted was that the process validation for a specific active pharmaceutical ingredient (API) did not adequately address instances where critical quality attributes exceeded established limits. Specifically, the validation report failed to discuss that the upper confidence limit for an unknown impurity in certain intermediate batches exceeded its specification limit. Furthermore, the report also overlooked that the upper confidence limit for a residual solvent in finished batches surpassed its specified acceptable level. These observations indicate potential non-compliance with good manufacturing practices, which mandate thorough and scientifically sound process validation to ensure product quality, safety, and efficacy. The firm is now required to address these deficiencies, investigate the root causes, and implement appropriate corrective and preventive actions. A comprehensive response to the FDA detailing their proposed actions is expected to resolve the noted issues and bring their manufacturing processes into full compliance.