# FDA 483 - Eisai Company Ltd. - November 02, 2022

Source: https://www.keypedia.com/records/483/eisai-company-ltd/aee28d15-0eba-4c4b-8cde-14e1369a692c

> FDA 483 for Eisai Company Ltd. on November 02, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eisai Company Ltd.
- Inspection Date: 2022-11-02
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection identified significant quality control issues at Eisai Company Ltd., a bulk finished drug manufacturer and contract testing laboratory located in Kakamigahara, Gifu, Japan. The inspection concluded with a Form FDA 483 issued on November 2, 2022, highlighting deficiencies in the firm's laboratory system.

The primary observations concerned inadequate laboratory controls and data integrity practices. Specifically, the FDA noted that the MI system used for critical testing procedures was not adequately secured. It lacked protection against unauthorized user modifications, such as renaming or deleting electronic data, and its Windows-based operating system permitted similar vulnerabilities. Crucially, the system did not possess audit trail capabilities, meaning that reviews could not verify data integrity or changes over time.

Furthermore, the inspection revealed that original raw electronic data from the Karl Fischer equipment, utilized for testing active pharmaceutical ingredients, was not properly retained. The system appeared to overwrite previous data, leading to a loss of original records. Similar to the MI system, this equipment also lacked essential audit trail functionalities, preventing comprehensive data audits.

These observations indicate that the company's laboratory controls did not establish scientifically sound and appropriate specifications, standards, and test procedures necessary to ensure the identity, strength, quality, and purity of in-process materials and drug products. Eisai Company Ltd. is expected to promptly address these serious deviations from current Good Manufacturing Practices by implementing robust corrective actions to resolve the identified data integrity and control weaknesses.

## Related Documents

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## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)

Company: https://www.keypedia.com/companies/eisai-company-ltd/3b8d9042-088d-4b84-9382-fcdcfd5ef360

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