FDA 483 - Sumitomo Dainippon Pharma Co., Ltd. - August 07, 2025

During an inspection conducted from August 3 to August 7, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Sumitomo Pharma Co., Ltd."s Suzuka Plant in Japan. This document details significant observations regarding the firm"s adherence to manufacturing quality standards for drug products. The FDA noted three primary issues. Firstly, the company"s raw material sampling procedures were found to be inadequate, as only one container per lot was sampled regardless of the total quantity received, lacking scientific justification and failing to ensure representativeness. Secondly, procedures to prevent objectionable microorganisms in non-sterile drug products were not established or followed, specifically regarding the water system. There was no documented microbial risk assessment for the water used in manufacturing and equipment cleaning, raising concerns about potential contamination. Lastly, the inspection revealed a failure to maintain complete backup files of electronic data generated by the visual inspection instrument, which is critical for detecting product defects. The system was not configured to save or transfer this essential data to retrievable storage, posing a risk to data integrity and auditability. These observations highlight deviations from Good Manufacturing Practices. Sumitomo Pharma Co., Ltd. is expected to address these findings by implementing comprehensive corrective actions to ensure product quality, safety, and regulatory compliance.