Company
United StatesEisai, Inc. - Inspection Records
Inspection records and compliance data for Eisai, Inc. in Nutley, New Jersey. 7 FDA inspections on record, last inspected May 02, 2025.
Company Profile
This profile covers Eisai, Inc. based in Nutley, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 3
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected September 27, 2010. Last inspected May 2, 2025.
Most cited issue areas
- Changes to Procedures Not Reviewed, Approved1 inspection
- Ensuring compliance with plan and protocol1 inspection
- General responsibilities of sponsors1 inspection
Most recent inspections
| Date | Classification | Office | Project area |
|---|---|---|---|
| May 2, 2025 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 9, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 16, 2018 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 9, 2015 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| April 20, 2015 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Documents (9)
FDA Inspection 1271039 - Eisai, Inc. - 2025-05-02
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FDA Inspection 1271039 - Eisai, Inc. - 2025-05-02
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FDA Inspection 1198163 - Eisai, Inc. - 2023-02-09
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483 - Eisai, Inc. - 2018-02-16
483
FDA Inspection 1041308 - Eisai, Inc. - 2018-02-16
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FDA Inspection 965277 - Eisai, Inc. - 2015-12-09
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FDA Inspection 922940 - Eisai, Inc. - 2015-04-20
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FDA Inspection 813538 - Eisai, Inc. - 2013-01-17
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FDA Inspection 683663 - Eisai, Inc. - 2010-09-27
fda_inspection
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Search nearby companiesCompany Information
Name
Eisai, Inc.
FEI Number
3009413786
State
New Jersey
City
Nutley
ID: 081df088-ce18-4702-a2b3-cb4e48ebe3e4