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

Source: https://www.keypedia.com/records/483/kyowa-pharma-chemical-co-ltd/c3ada0ad-dd7f-4c43-b6d8-acc1891d4de5

> 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 Partnerships
- Summary: KYOWA PHARMA CHEMICAL CO, LTD in Toyama, Japan, a manufacturer of Active Pharmaceutical Ingredients, was cited for significant deficiencies across its quality system, facilities, equipment, production controls, and laboratory controls. Issues include inadequate complaint handling, product quality reviews, investigation justifications, cleaning validation, record-keeping, environmental monitoring, and general lab practices. These observations indicate a broad lack of adherence to good manufacturing practices.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/kyowa-pharma-chemical-co-ltd/6f8ede71-74a8-41b2-b7af-e289bc91d362)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3