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

Source: https://www.globalkeysolutions.net/records/483/shiratori-pharmaceutical-co-ltd/a3c880f1-4ec0-40ef-a783-17d8bb22b3d9

> FDA 483 for Shiratori Pharmaceutical Co. Ltd. on October 18, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shiratori Pharmaceutical Co. Ltd.
- Inspection Date: 2019-10-18
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Officers

- [Shuh B. Rhee](https://www.globalkeysolutions.net/people/shuh-b-rhee/babd79c1-f438-4991-8840-3b78db3d1317)

Company: https://www.globalkeysolutions.net/companies/shiratori-pharmaceutical-co-ltd/b0f2766e-fda1-48c1-92ff-70efc88645b0

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1