# FDA 483 - Shionogi Pharma Co. Ltd. - August 05, 2016

Source: https://www.keypedia.com/records/483/shionogi-pharma-co-ltd/2d8d6826-370e-44cb-80ab-c00149046066

> FDA 483 for Shionogi Pharma Co. Ltd. on August 05, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shionogi Pharma Co. Ltd.
- Inspection Date: 2016-08-05
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Shionogi Pharma Chemicals Co., Ltd. in Tokushima, Japan, revealed significant deficiencies across quality control, computerized systems, quality assurance, and manufacturing processes. The observations indicate a lack of robust data integrity controls, inadequate quality management system implementation, and insufficient process validation and documentation practices. These issues collectively suggest a moderate to severe level of non-compliance with cGMP regulations.

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## Related Officers

- [Cheryl A. Clausen](https://www.keypedia.com/people/cheryl-a-clausen/2306b2bc-8f01-4f77-ba2d-1a3186d6f6fc)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd