FDA 483 - Otsuka Pharmaceutical Co., Ltd. - July 07, 2025

An FDA inspection of Otsuka Pharmaceutical Co., Ltd. in Kanzaki-Gun, Saga, Japan, revealed significant deficiencies in their API manufacturing processes. The firm failed to ensure that test methods and specifications for a critical (b)(4) API reference standard were scientifically sound and appropriately validated. This included a lack of validation for the in-house reference standard and insufficient quality oversight during its manufacturing.