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

Sunsho Pharmaceutical Co., Ltd. in Fuji-shi, Shizuoka, Japan, a dietary supplement manufacturer, received a Form 483 with five observations. The inspection revealed significant deficiencies in establishing specifications for components and finished products, using scientifically valid testing methods, and maintaining complete batch and master manufacturing records. These issues indicate a lack of adequate controls to ensure the quality and identity of dietary supplements for the U.S. market.