Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-05-02.
At a glance
Inspections
4
Form 483s
2
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Apr 2025 – 2 May 2025 | Human Drugs | Clean | |
| 30 Jan 2023 – 9 Feb 2023 | Human Drugs | Clean | |
| 18 Jan 2018 – 16 Feb 2018 | Human Drugs | 483 | View 483 → |
| 4 Dec 2015 – 9 Dec 2015 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Feb 2018
21 CFR 312.50
Ensuring compliance with plan and protocol
Cited by Nina Yang, Peter R Lenahan, Jean M Mulinde, Lauren C Iacono-Connors
16 Feb 2018
21 CFR 312.50
Ensuring compliance with plan and protocol
Cited by Nina Yang, Peter R Lenahan, Jean M Mulinde, Lauren C Iacono-Connors
16 Feb 2018
21 CFR 312.50
Ensuring compliance with plan and protocol
Cited by Nina Yang, Peter R Lenahan, Jean M Mulinde, Lauren C Iacono-Connors
9 Dec 2015
21 CFR 312.50
General responsibilities of sponsors
Cited by Peter R Lenahan, Jean M Mulinde, Lauren C Iacono-Connors
Investigators
FDA investigators tied to this site in the record.
Peter R Lenahan2 insp.
Jean M Mulinde2 insp.
Lauren C Iacono-Connors2 insp.
Mayar M Mussa1 insp.
Michael Serrano1 insp.
Nina Yang1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 312.50 | Cited across public-safe Form 483 observations | 4x |
Full site report
Get the verbatim findings behind Eisai, Inc.'s 2 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