# FDA 483 - Daito Pharmaceutical Co., Ltd. - December 19, 2023

Source: https://www.globalkeysolutions.net/records/483/daito-pharmaceutical-co-ltd/cf452e09-1736-4778-8b0b-99a60c8c3188

> FDA 483 for Daito Pharmaceutical Co., Ltd. on December 19, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Daito Pharmaceutical Co., Ltd.
- Inspection Date: 2023-12-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Daito Pharmaceutical Co., Ltd. in Toyama-City, Japan, revealed significant deficiencies in manufacturing controls and quality assurance. The firm lacked adequate written procedures for equipment cleaning and cross-contamination monitoring, and failed to qualify non-pharmacopeia standards used for raw material testing against USP reference standards. These issues indicate a lack of robust controls to ensure drug product quality and purity.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/truong-x-nguyen/8f3aed17-0507-4272-a3b8-9188d761faed)

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