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

Hisamitsu Pharmaceutical Co., Inc. in Tosu, Saga, Japan, received a Form 483 from the FDA following an inspection from June 30 to July 4, 2025. The inspection revealed significant deficiencies in quality control, including inadequate investigations into unexplained discrepancies and a failure to establish and follow robust production and process control procedures. Additionally, the firm demonstrated insufficient laboratory controls for water system monitoring and microbial testing, indicating a lack of assurance regarding drug product quality and purity.