Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2015-12-10.
At a glance
Inspections
6
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Dec 2015 – 10 Dec 2015 | Human Drugs | 483 | View 483 → |
| 9 Sep 2013 – 13 Sep 2013 | Human Drugs | 483 | View 483 → |
| 15 Jul 2011 | Not recorded | 483 | View 483 → |
| 19 Nov 2010 | Not recorded | Clean | |
| 18 Nov 2008 | Not recorded | 483 | View 483 → |
| 29 Apr 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Dec 2015
21 CFR 211.142
Written warehousing procedures established/followed
Cited by Adam R Cooke, Seneca D Toms, Sonya M Edmonds, Christopher S Keating
10 Dec 2015
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Adam R Cooke, Seneca D Toms, Sonya M Edmonds, Christopher S Keating
10 Dec 2015
21 CFR 211.42(c)(10)(iii)
Air Supply
Cited by Adam R Cooke, Seneca D Toms, Sonya M Edmonds, Christopher S Keating
10 Dec 2015
21 CFR 211.84(d)(2)
Component written specification
Cited by Adam R Cooke, Seneca D Toms, Sonya M Edmonds, Christopher S Keating
Investigators
FDA investigators tied to this site in the record.
Bonita S Chester2 insp.
Adam R Cooke1 insp.
Seneca D Toms1 insp.
Sonya M Edmonds1 insp.
Christopher S Keating1 insp.
Jason F Chancey1 insp.
Hai Lien T Phung1 insp.
Thomas R Berry1 insp.
Penny H Mccarver1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.115(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.142(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c)(10)(iii) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Eisai Inc's 4 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat