FDA Inspection
Eisai IncEisai Inc – FDA Inspection, Nov 18, 2008
Record Details
This FDA Inspection record concerns Eisai Inc, with an inspection on November 18, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Eisai Inc
- Inspection Date
- November 18, 2008
- Product Type
- Drugs
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ID · 369daf86-5868-4da8-a6ea-9993f9415db7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 569945
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.84(d)(3)Certificates of Testing (Containers, Closures)
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.115(b)Reprocessing/quality control unit
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Eisai Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 10, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 |
Other documents for Eisai Inc
- FDA Inspection 952360 - 2015-12-10
- FDA Inspection 849642 - 2013-09-13
- FDA Inspection 749455 - 2011-07-15
- FDA Inspection 700168 - 2010-11-19
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