# FDA 483 - Shionogi Pharma Co., Ltd. - March 15, 2019

Source: https://www.globalkeysolutions.net/records/483/shionogi-pharma-co-ltd/c4c8272e-ec4e-4289-b741-2c8a3e43d3d1

> FDA 483 for Shionogi Pharma Co., Ltd. on March 15, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shionogi Pharma Co., Ltd.
- Inspection Date: 2019-03-15
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Shionogi & Co., Ltd. in Isawa-gun, Iwate, Japan, an API and sterile drug product manufacturer, revealed significant deficiencies. Observations included inadequate facility cleaning procedures lacking full details and production batch records that failed to consistently identify equipment and location information.

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## Related Officers

- [Jiao Yang, Ph.D., Chemist](https://www.globalkeysolutions.net/people/jiao-yang-phd-chemist/c9329d2a-2745-4d4f-b16b-dedc126999d5)
- [Stephanie A. Slater, M.S., Drug Specialist](https://www.globalkeysolutions.net/people/stephanie-a-slater-ms-drug-specialist/65afcdb8-0bac-4f50-b0d5-10a54c85eded)

Company: https://www.globalkeysolutions.net/companies/shionogi-pharma-co-ltd/bb3e5dcd-52f9-4971-9747-4c04b63ba0fa

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