Morishita Jintan Co., Ltd. – FDA 483, 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.
ID · 8acbeca2-3bfe-4a51-8be2-98ba099698f6
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