# FDA 483 - Daito Pharmaceutical Co., Ltd. - January 31, 2020

Source: https://www.globalkeysolutions.net/records/483/daito-pharmaceutical-co-ltd/0e05b2e7-d007-44b8-82a3-763fe0ec6565

> FDA 483 for Daito Pharmaceutical Co., Ltd. on January 31, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Daito Pharmaceutical Co., Ltd.
- Inspection Date: 2020-01-31
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: The FDA inspection of Daito Pharmaceutical Co., Ltd. in Toyama, Japan, revealed significant deficiencies across laboratory controls, data integrity, equipment management, and quality systems. Repeated observations from a previous inspection indicate persistent issues with computerized system controls, supplier evaluation, and GMP documentation. The findings suggest a systemic lack of control over critical manufacturing processes and data.

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## Related Officers

- [Cheryl A. Clausen](https://www.globalkeysolutions.net/people/cheryl-a-clausen/2306b2bc-8f01-4f77-ba2d-1a3186d6f6fc)

Company: https://www.globalkeysolutions.net/companies/daito-pharmaceutical-co-ltd/3a27bbaf-60c1-44b3-acf3-48f8935483e8

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