Company
United StatesEisai Inc, Research Triangle Park, NC – FDA Inspections
Inspection records and compliance data for Eisai Inc in Research Triangle Park, North Carolina. 5 FDA inspections on record, last inspected December 10, 2015.
Company Profile
This profile covers Eisai Inc based in Research Triangle Park, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 4
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected November 18, 2008. Last inspected December 10, 2015.
Most cited issue areas
- Procedures not in writing, fully followed2 inspections
- Air Supply1 inspection
- Authority lacking to review records, investigate errors1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 10, 2015 | VAI | Human Drugs · Drug Quality Assurance | 952360 |
| September 13, 2013 | VAI | Human Drugs · Drug Quality Assurance | 849642 |
| July 15, 2011 | VAI | Human Drugs · Drug Quality Assurance | 749455 |
| November 19, 2010 | NAI | Human Drugs · Drug Quality Assurance | 700168 |
| November 18, 2008 | VAI | Human Drugs · Drug Quality Assurance | 569945 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Eisai Inc
FEI Number
3001753294
Address
900 Davis Dr, Research Triangle Park, North Carolina 27709, United States
Country
United States
ID: 2b3d502f-3252-4131-844e-9b0c6e0e8c6b