FDA 483 - Shiratori Pharmaceutical Co. Ltd. - October 18, 2019

An FDA inspection of Shiratori Pharmaceutical Co. Ltd. in Chiba, Japan, an Active Pharmaceutical Ingredient Manufacturer, revealed a significant quality control issue. The firm's quality unit failed to ensure that critical deviations, specifically non-conforming Out of Specification (OOS) results for long-term stability turbidity, were properly investigated and resolved. This indicates a breakdown in the company's quality management system regarding deviation handling.