Overview
- 6 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-11.
At a glance
Inspections
6
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Jul 2025 – 11 Jul 2025 | Human Drugs | 483 | On file |
| 28 Jan 2019 – 1 Feb 2019 | Human Drugs | 483 | On file |
| 4 Apr 2016 – 8 Apr 2016 | Human Drugs | 483 | On file |
| 1 Dec 2014 – 5 Dec 2014 | Human Drugs | 483 | On file |
| 25 Jul 2012 | Not recorded | 483 | On file |
| 14 Oct 2011 | Not recorded | 483 | On file |
Investigators
FDA investigators tied to this site in the record.
Marian E Ramirez1 insp.
Zachary L Stamm1 insp.
Saleem A Akhtar1 insp.
Uduak M Inokon1 insp.
Linda L Ng1 insp.
Alice S Tsao1 insp.
Steven M Weinman1 insp.
Luis A Dasta1 insp.
Full site report
Get the verbatim findings behind Otsuka Pharmaceutical Co., Ltd.'s 6 Form 483s
The full inspection record, as Atlas holds it, 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