FDA 483 - Hisamitsu Pharmaceutical Co., Inc. - July 11, 2025

An FDA Form 483 was issued to the manufacturing facility managed by Norifumi Tanida following an inspection conducted from July 7-11, 2025. The observations highlight significant deficiencies in the firm's quality control and manufacturing processes for drug products. Key violations include a pervasive failure to thoroughly investigate unexplained discrepancies and batch failures. This was evident in inadequate investigations for a foreign matter incident involving metal fragments and multiple customer complaints concerning product defects and adverse events. The firm also failed to establish scientifically sound specifications and test procedures, specifically lacking impurity testing and specifications for drug products with active ingredients known to contain impurities. Furthermore, the stability program was deemed inadequate, as stability testing methods did not include known or unknown impurities, and there was no data demonstrating that assay testing methods were stability-indicating. Additional issues included incomplete laboratory records, with the use of unqualified secondary reference standards, and cleaning validation studies that failed to assess microbial contamination risk for equipment. These observations indicate non-compliance with Current Good Manufacturing Practices (CGMP) for drug products. The facility is required to respond to these findings by developing and implementing comprehensive corrective and preventive actions to ensure product quality, safety, and regulatory adherence.