FDA 483 - Xiamen Kang Zhongyuan Biotechnology Co., Ltd. - August 12, 2025

Xiamen Kang Zhongyuan Biotechnology Co. Ltd. in Xiamen, China, was inspected by the FDA, revealing severe deficiencies in its manufacturing and quality control processes for OTC drug products. The inspection uncovered fraudulent active ingredient testing reports, a lack of a proper stability program, inadequate process controls, and significant issues with component testing and quality unit responsibilities. These findings indicate a systemic failure to ensure the identity, strength, purity, and quality of drug products.