FDA 483 - Taiho Pharmaceutical Co., Ltd. - January 26, 2024

An FDA inspection of Taiho Pharmaceutical Co., Ltd., a bulk drug manufacturer in Itano-Gun, Tokushima, Japan, revealed significant deficiencies in equipment maintenance and laboratory controls. Inspectors observed that corroded equipment was used for an extended period without proper investigation or justification, impacting tablet manufacturing. Additionally, the firm failed to perform adequate growth promotion testing for microbial media used in product testing.