FDA Inspection
Eisai Company Ltd.Eisai Company Ltd. – FDA Inspection, Dec 21, 2018
Record Details
This FDA Inspection record concerns Eisai Company Ltd., with an inspection on December 21, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e4025b48-26aa-4c29-9ec6-457e3a738bb4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1075048
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.67(b)Written procedures fail to include
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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 | |
| October 27, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 28, 2019 | Not classified | Office of Inspections and Investigations | |
| 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 1223670 - 2023-10-27
- FDA Inspection 1098772 - 2019-06-28
- FDA Inspection 961572 - 2016-02-19
- FDA Inspection 781766 - 2012-04-26
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