FDA 483 - Fujimoto Chemicals Co., Ltd. - May 12, 2023

An FDA inspection of Fujimoto Chemicals Co., Ltd.'s Senboku Plant, an Active Pharmaceutical Ingredient (API) manufacturer in Izumiotsu, Osaka, revealed significant deficiencies in their supplier management program. The firm failed to adequately validate supplier reports of analyses for raw ingredients and did not perform required audits for critical suppliers, leaving major findings unverified. These issues indicate a lack of robust quality control over incoming materials.