# FDA 483 - Daito Pharmaceutical Co., Ltd. - September 16, 2022

Source: https://www.globalkeysolutions.net/records/483/daito-pharmaceutical-co-ltd/43e3bd6c-533d-44a9-8a0a-25124a4a7827

> FDA 483 for Daito Pharmaceutical Co., Ltd. on September 16, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Daito Pharmaceutical Co., Ltd.
- Inspection Date: 2022-09-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Daito Pharmaceutical Co., Ltd. in Toyama City, Japan, was inspected by the FDA from September 12-16, 2022. The inspection revealed two significant issues related to quality control unit procedures and the handling of investigations into unexplained discrepancies. These observations indicate deficiencies in the firm's quality management system.

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## Related Officers

- [https://www.fda.gov/media/120628/download](https://www.globalkeysolutions.net/people/santiago-gallardo-johnson/f5086b0c-c8fc-44dd-8d12-6506b9dd313f)

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