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

Fujimoto Chemicals Co., Ltd. (Senboku Plant), an Active Pharmaceutical Ingredient (API) manufacturer in Izumiotsu, Osaka, was cited for deficiencies in establishing the reliability of component suppliers. The inspection revealed issues with verifying certificates of analyses for raw ingredients and a lack of current supplier audits for critical suppliers, with unverified corrective actions for major findings.