FDA 483 - Otsuka Pharmaceutical Co., Ltd. - June 17, 2026

During an FDA inspection conducted from June 9-17, 2025, Otsuka Pharmaceutical Co., Ltd., a sterile drug product manufacturer in Naka-Gun, Tokushima, Japan, received a Form FDA 483 outlining four significant observations. The firm was cited for failing to establish adequate written procedures for production and process controls, specifically noting a deficient process performance qualification study that lacked scientific justification for batch sizes. Procedures intended to prevent microbiological contamination of sterile products were deemed insufficient due to inadequate aseptic process validation. This was evidenced by a deficient disinfectant efficacy study, which failed to achieve required log reductions, omitted critical surfaces and USP-recommended organisms, and used methods inconsistent with routine cleaning practices.

Furthermore, deficiencies were identified in the environmental monitoring system for aseptic processing areas, as critical Grade A filling lines lacked necessary surface sampling for microbiological testing after drug product suspension filling. Lastly, laboratory controls were found to be insufficient, particularly concerning growth promotion testing procedures that did not incorporate inhouse isolates for environmental monitoring media. These observations highlight areas of non-adherence to Good Manufacturing Practices (GMP) for sterile drug products. Otsuka Pharmaceutical Co., Ltd. is required to address these findings by developing and implementing comprehensive corrective and preventive actions and submitting a response to the FDA outlining their plan.