FDA 483 - Zhejiang Shenzhou Pharmaceutical Co., Ltd. - September 12, 2025

Zhejiang Shenzhou Pharmaceutical Co. Ltd, a manufacturer of bulk drug substances in Taizhou, China, was cited for significant quality system deficiencies during an FDA inspection. Observations included inadequate Out of Specification investigations, failure to microbiologically test water used in drug substance production, non-adherence to equipment cleaning procedures, and unestablished accuracy of critical test methods. These issues indicate a lack of robust quality control and potential risks to product quality.