FDA Inspection
Eisai IncEisai Inc – FDA Inspection, Dec 10, 2015
Record Details
This FDA Inspection record concerns Eisai Inc, with an inspection on December 10, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Eisai Inc
- Inspection Date
- December 10, 2015
- Product Type
- Drugs
View Company Profile
ID · 71272b25-dbc7-44fc-be1d-6b441fa11537
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 952360
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.84(d)(2)Component written specification
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Eisai Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 15, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 19, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 18, 2008 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Eisai Inc
- FDA Inspection 849642 - 2013-09-13
- FDA Inspection 749455 - 2011-07-15
- FDA Inspection 700168 - 2010-11-19
- FDA Inspection 569945 - 2008-11-18
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