# FDA 483 - Shionogi Pharma Co., Ltd. - July 01, 2025

Source: https://www.globalkeysolutions.net/records/483/shionogi-pharma-co-ltd/856fc985-e4e1-44a9-afc6-0a86a40aaf4a

> FDA 483 for Shionogi Pharma Co., Ltd. on July 01, 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: 2025-07-01
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Shionogi Pharma Co., Ltd. in Isawa-Gun, Japan, a sterile drug manufacturer, received a Form 483 citing significant deficiencies in its aseptic processing and contamination control. Observations included inadequate procedures for preventing microbiological contamination during interventions, deficiencies in cleaning and disinfection systems, and insufficient validation of aseptic processes through airflow visualization studies. Additionally, the firm lacked adequate controls to prevent cross-contamination of highly potent pharmaceutical products, with multiple instances of contamination detected.

## Related Documents

- [483 - 2019-03-15](https://www.globalkeysolutions.net/records/483/shionogi-pharma-co-ltd/c4c8272e-ec4e-4289-b741-2c8a3e43d3d1)

## Related Officers

- [Consumer Safety Officer ](https://www.globalkeysolutions.net/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)
- [Drug Investigator](https://www.globalkeysolutions.net/people/jessica-s-estriplet/b7152ec3-6e1b-45aa-840e-7147f357aea2)

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

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