483
Shiratori Pharmaceutical Co. Ltd.Shiratori Pharmaceutical Co. Ltd. – FDA 483, Oct 18, 2019
Record Details
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.
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ID · a3c880f1-4ec0-40ef-a783-17d8bb22b3d9
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