FDA 483 - Zhuhai Rundu Pharmaceutical Co Ltd - February 17, 2025

Zhuhai Rundu Pharmaceutical Co., Ltd., an API manufacturer in Zhuhai, China, was cited for significant quality control deficiencies. Observations included inadequate cleaning and maintenance of equipment, poor record-keeping practices, insufficient investigation of out-of-specification results, and a failure to conduct microbiological testing for distributed APIs. These issues indicate a lack of robust quality systems and potential risks to product quality.