FDA 483 - Morishita Jintan Co., Ltd. - May 19, 2023

An FDA inspection of Morishita Jintan Co., Ltd., a homeopathic drug manufacturer in Tsukumi-Gun, Shiga, Japan, revealed significant deficiencies across production, laboratory controls, and stability testing. The firm failed to validate manufacturing processes and an ERP software system, lacked scientifically sound microbial specifications for a drug product, and conducted stability studies using an inappropriate container-closure system. These issues indicate a lack of adequate controls to assure drug product quality and purity.