FDA 483 - Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. - July 11, 2025

An FDA inspection conducted on July 11, 2025, at Otsuka Pharmaceutical Co., Ltd.'s Saga Factory in Japan, an Active Pharmaceutical Ingredient (API) manufacturer, resulted in a Form FDA 483 outlining significant observations. The primary issue identified was the company's failure to ensure that all specifications and test procedures are scientifically sound and appropriate to guarantee the quality and purity of its APIs. Specifically, the inspection noted that the test method used for the reference standard, critical for assessing ys API and PN products, had not been adequately validated to confirm its suitability for intended use. Furthermore, Otsuka Pharmaceutical failed to demonstrate that its in-house reference standard and test methods were equivalent to, or superior to, the established United States Pharmacopeia (USP) compendial methods. The observations also highlighted a lack of adequate quality oversight for the manufacturing process and associated records of reference standards produced within the company's Research and Development Laboratory. These observations, issued under the regulatory framework of the FDA, require Otsuka Pharmaceutical Co., Ltd. to address the identified deficiencies promptly. The company is expected to provide a comprehensive response detailing the corrective and preventive actions implemented to ensure compliance with quality standards for pharmaceutical manufacturing.