FDA 483 - Sunsho Pharmaceutical Co., Ltd. - April 17, 2025

Sunsho Pharmaceutical Co., Ltd. in Fuji-shi, Shizuoka, Japan, was inspected regarding its dietary supplement manufacturing operations. The inspection revealed significant deficiencies in establishing and following specifications for components and finished products, as well as issues with record-keeping and process control. These observations indicate a lack of robust quality control and adherence to manufacturing regulations.