FDA 483 - Otsuka Pharmaceutical Co., Ltd. - February 28, 2019

An FDA inspection of Otsuka Pharmaceutical Co., Ltd., a drug substance manufacturer in Omagari, Japan, identified two significant issues. The firm failed to thoroughly investigate and document unexpected discrepancies, including inadequate root cause analysis and delayed corrective actions. Additionally, the inspection found insufficient control over warehouse temperatures for raw materials and finished API, with validation failing to establish proper air conditioning settings.