# FDA 483 - Shionogi Pharma Co., Ltd. - May 30, 2025

Source: https://www.keypedia.com/records/483/shionogi-pharma-co-ltd/833daad8-0cfb-4648-9bda-947515be328d

> FDA 483 for Shionogi Pharma Co., Ltd. on May 30, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shionogi Pharma Co., Ltd.
- Inspection Date: 2025-05-30
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Shionogi Pharma Co. Ltd. in Seitsu, Osaka, Japan, was cited for three observations during an FDA inspection. The firm failed to thoroughly review unexplained discrepancies, particularly regarding foreign matter in drug product batches. Additionally, the written stability program was inadequate, not ensuring drug products are tested in their marketed container-closure systems, and procedures for testing incoming components lacked sufficient detail to prevent foreign matter contamination.

## Related Documents

- [483 - 2025-09-20](https://www.keypedia.com/records/483/shionogi-pharma-co-ltd/98b7e68d-83a4-4954-8f8a-0837f8c42dad)

## Related Officers

- [Lillian S. Wu](https://www.keypedia.com/people/lillian-s-wu/b1f6643c-ac01-43e5-8ce2-e6f4fdba9d35)

Company: https://www.keypedia.com/companies/shionogi-pharma-co-ltd/97a7893d-fd4c-45bc-9237-0e03e7d8af7c

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8