Company
JapanEisai Company Ltd., Kakamigahara, Japan – FDA Inspections
Inspection records and compliance data for Eisai Company Ltd. in Kakamigahara. 7 FDA inspections on record, 4 Form 483s, last inspected June 05, 2026.
Company Profile
This profile covers Eisai Company Ltd. based in Kakamigahara, Japan.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Unclassified
- 2
- Form 483s
- 4
- Warning letters
- 0
First inspected September 11, 2009. Last inspected June 5, 2026.
Most cited issue areas
- Calibration/Inspection/Checking not done1 inspection
- Cleaning / Sanitizing / Maintenance1 inspection
- Establishment of time limitations1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 5, 2026 | Not classified | Human Drugs | 1323778 |
| October 27, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1223670 |
| June 28, 2019 | Not classified | Human Drugs | 1098772 |
| December 21, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1075048 |
| February 19, 2016 | NAI | Human Drugs · Drug Quality Assurance | 961572 |
| April 26, 2012 | NAI | Human Drugs · Drug Quality Assurance | 781766 |
| September 11, 2009 | NAI | Human Drugs · Drug Quality Assurance | 615164 |
FDA documents
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Company Information
Name
Eisai Company Ltd.
FEI Number
3004967045
Address
Kawashimatakehaya-Machi 1, Kawashimatakehaya-Machi, Kakamigahara, Japan
Country
Japan
ID: 3b8d9042-088d-4b84-9382-fcdcfd5ef360