# FDA 483 - Shionogi Pharma Co. Ltd. - October 20, 2023

Source: https://www.globalkeysolutions.net/records/483/shionogi-pharma-co-ltd/7fdd5d6a-6207-489b-af21-6817f9d78a7a

> FDA 483 for Shionogi Pharma Co. Ltd. on October 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shionogi Pharma Co. Ltd.
- Inspection Date: 2023-10-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Shionogi Pharma Co., Ltd. in Tokushima, Japan, was cited for significant deficiencies across its quality control and manufacturing processes. Observations included inadequate Out-of-Specification investigations, unvalidated analytical and cleaning methods, and insufficient laboratory controls. Additionally, the firm's water sampling practices were found to be unrepresentative, and microbial risk assessments were lacking.

## Related Documents

- [483 - 2016-08-05](https://www.globalkeysolutions.net/records/483/shionogi-pharma-co-ltd/2d8d6826-370e-44cb-80ab-c00149046066)

## Related Officers

- [Lata C. Mathew](https://www.globalkeysolutions.net/people/lata-c-mathew/0610a0ef-dcc5-43e7-ab74-2ac54d758beb)

Company: https://www.globalkeysolutions.net/companies/shionogi-pharma-co-ltd/d403b7f0-ba88-4145-a303-36fd7f698ff2

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