# FDA 483 - Eisai, Inc. - April 09, 2024

Source: https://www.globalkeysolutions.net/records/483/eisai-inc/830bab14-5657-481b-8edc-c439a9854f7d

> FDA 483 for Eisai, Inc. on April 09, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eisai, Inc.
- Inspection Date: 2024-04-09
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: Eisai, Inc. in Baltimore, MD, was cited for significant deficiencies in its quality control and equipment management systems. The inspection revealed failures in calibrating critical manufacturing equipment, inadequate investigations into environmental monitoring excursions, and a lack of timely Out-Of-Specification (OOS) investigations. These issues indicate a moderate level of non-compliance with good manufacturing practices.

## Related Officers

- [Yaharn Su](https://www.globalkeysolutions.net/people/yaharn-su/75b7f7fd-d853-436e-b538-386a8c6df3cb)
- [Azzerat M Lawal](https://www.globalkeysolutions.net/people/azzerat-m-lawal/750d803e-1fc1-40f8-b623-4ed7744e7bb1)
- [issuing_officer](https://www.globalkeysolutions.net/people/catherine-o-lamptey/9ddfa564-70b7-4a8b-9209-9d21205ebf60)
- [Investigator](https://www.globalkeysolutions.net/people/pushpa-s-jayasekara/cfd7d22f-b4c2-4002-ae18-b5435815d27d)

Company: https://www.globalkeysolutions.net/companies/eisai-inc/1e0d6af4-f962-4ac0-826f-90ce5f71a0a3

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64