# FDA 483 - Kyowa Chemical Industry Co., Ltd. - March 29, 2019

Source: https://www.globalkeysolutions.net/records/483/kyowa-chemical-industry-co-ltd/1175d1fb-a2cc-4b1d-8507-90ba0dc989ef

> FDA 483 for Kyowa Chemical Industry Co., Ltd. on March 29, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kyowa Chemical Industry Co., Ltd.
- Inspection Date: 2019-03-29
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: Kyowa Chemical Industry Co., Ltd. in Sakaide, Japan, an API manufacturer, was cited for significant data integrity and facility control deficiencies during an FDA inspection. Observations included a lack of oversight for QC laboratory systems, inadequate data backup and verification, and unrestricted access to raw material and finished product warehouses and production areas. These issues indicate a serious breakdown in quality control and security protocols.

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/sangeeta-m-khurana/bed4533f-a9aa-47c5-9e0b-f20ad36461aa)

Company: https://www.globalkeysolutions.net/companies/kyowa-chemical-industry-co-ltd/8e467a76-b49f-4a93-b61a-b99aab0ded0e

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4