FDA 483 - Asanuma Corporation - Sagamihara Factory - February 28, 2025

An FDA inspection of Assnuma Corporation - Sagamihara Factory, an OTC pharmaceutical manufacturer, revealed significant deficiencies in quality control. Observations included a failure to conduct specific identification tests on components, inadequate analytical method validation for detecting API residues during cleaning validation, and issues with control procedures for manufacturing process validation. These findings indicate a lack of scientifically sound procedures to ensure product identity, strength, quality, and purity.