# FDA 483 - Kyowa Hakko Bio Co., Ltd. - April 11, 2022

Source: https://www.globalkeysolutions.net/records/483/kyowa-hakko-bio-co-ltd/911e3418-d0c9-42ad-a767-662ef0cf7b3d

> FDA 483 for Kyowa Hakko Bio Co., Ltd. on April 11, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kyowa Hakko Bio Co., Ltd.
- Inspection Date: 2022-04-11
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Kyowa Hakko Bio Co., Ltd. in Hofu-city, Japan, an API manufacturer, received a Form 483 with five observations. The inspection revealed significant deficiencies in the quality control unit's adherence to procedures, inadequate evaluation of change control impacts on API quality, insufficient water monitoring specifications, and inadequate laboratory and production system controls. These issues indicate a systemic lack of robust quality management and control.

## Related Documents

- [483 - 2019-11-08](https://www.globalkeysolutions.net/records/483/kyowa-hakko-bio-co-ltd/2b59b559-fc24-4243-abb8-b6ee8265f928)
- [483 - 2022-04-15](https://www.globalkeysolutions.net/records/483/kyowa-hakko-bio-co-ltd/7b12c58e-9ab6-4010-a7a1-ec3c5a80793b)

## Related Officers

- [Teresa I. Navas](https://www.globalkeysolutions.net/people/teresa-i-navas/43f747c0-18c2-4630-bab9-936204aa93aa)

Company: https://www.globalkeysolutions.net/companies/kyowa-hakko-bio-co-ltd/4ab0756a-78b6-4060-8087-809db6e7941b

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