FDA 483 - Hisamitsu Pharmaceutical Co., Inc. - July 04, 2025

Hisamitsu Pharmaceutical Co., Inc., located in Saga, Japan, underwent an FDA inspection from June 30 to July 4, 2025. The inspection revealed significant concerns regarding the company's adherence to good manufacturing practices, specifically in its quality control, production process controls, and laboratory control systems. Key observations included a failure to thoroughly investigate unexplained discrepancies and batch failures. The firm's deviation reports often lacked scientific rationale, root cause analysis supported by data, or proper justification, exemplified by issues with assessing lots using failed APIs and justifying balance calibration without documented rationale. Furthermore, Hisamitsu Pharmaceutical Co., Inc. was cited for inadequate written procedures for production and process controls. Standard operating procedures were found to be unclear, lacking detailed instructions and specific timeframes for investigating and approving trouble and deviation reports, leading to untimely investigations. Finally, the inspection identified deficiencies in laboratory controls. The company failed to adequately monitor its water for injection (WFI) system to ensure it consistently met USP monograph specifications and appropriate microbiological limits. Specifically, existing test methods did not include testing for objectionable microorganisms such as Burkholderia cepacia complex. These observations indicate areas where Hisamitsu Pharmaceutical Co., Inc. must implement robust corrective actions to ensure product quality, purity, and patient safety, as required by FDA regulations.