Nanjing Chengong Pharmaceutical Co., Ltd. – FDA 483, Sep 11, 2026

Nanjing Chengong Pharmaceutical Co. Ltd., an API manufacturer in Nanjing, China, was cited for significant deficiencies related to the accuracy and traceability of Certificates of Analysis (CoAs) for distributed Active Pharmaceutical Ingredients. The firm failed to adequately test, review, and approve CoAs for third-party manufactured APIs, and lacked an effective quality management system to ensure the authenticity and traceability of these products. Furthermore, the company did not maintain transparency regarding the original manufacturers of APIs distributed to the United States market.