# FDA 483 - Kyowa Pharma Chemical Co Ltd - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/kyowa-pharma-chemical-co-ltd/6f8ede71-74a8-41b2-b7af-e289bc91d362

> FDA 483 for Kyowa Pharma Chemical Co Ltd on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kyowa Pharma Chemical Co Ltd
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of KYOWA PHARMA CHEMICAL CO, LTD in Toyama, Japan, revealed significant deficiencies across multiple areas of their quality system. The firm failed to adequately follow quality unit responsibilities, conduct complete cleaning validation studies, maintain accurate records, and ensure proper laboratory controls. These findings indicate a need for comprehensive improvements in the firm's manufacturing and quality assurance practices.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/noreen-muniz/0bb20d12-62ad-42aa-8b0a-c44b339d413f)

Company: https://www.globalkeysolutions.net/companies/kyowa-pharma-chemical-co-ltd/abbdeec9-240e-41e0-a8fd-2d49162d244a

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