FDA Inspection
Eisai Company Ltd.Eisai Company Ltd. – FDA Inspection, Oct 27, 2023
Record Details
This FDA Inspection record concerns Eisai Company Ltd., with an inspection on October 27, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 257889a2-89ea-440f-899b-b9b142ba43fb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1223670
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Eisai Company Ltd.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 5, 2026 | Not classified | Office of Inspections and Investigations | |
| June 28, 2019 | Not classified | Office of Inspections and Investigations | |
| December 21, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 19, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 26, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Eisai Company Ltd.
- FDA Inspection 1323778 - 2026-06-05
- FDA Inspection 1098772 - 2019-06-28
- FDA Inspection 1075048 - 2018-12-21
- FDA Inspection 961572 - 2016-02-19
- FDA Inspection 781766 - 2012-04-26
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