FDA 483 - Shanghai Desano Bio-Pharmaceutical Co., Ltd. - August 02, 2019

Shanghai Desano Bio-Pharmaceutical Co., Ltd. in Shanghai, China, was inspected and cited for several significant deficiencies in its drug product manufacturing operations. Observations included inadequate control procedures for product uniformity, insufficient computer system controls leading to data integrity concerns, deficient equipment cleaning validation, and a lack of written procedures for the quality control unit, specifically for Field Alert Reports. These issues indicate a need for improved quality management and adherence to GMP regulations.