Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-10-10.
At a glance
Inspections
7
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Oct 2025 – 10 Oct 2025 | Human Drugs | Clean | |
| 11 Feb 2019 – 15 Feb 2019 | Human Drugs | 483 | View 483 → |
| 18 Jul 2016 – 22 Jul 2016 | Human Drugs | 483 | View 483 → |
| 17 Mar 2014 – 20 Mar 2014 | Human Drugs | 483 | View 483 → |
| 21 Oct 2011 | Not recorded | 483 | View 483 → |
| 4 Mar 2008 | Not recorded | 483 | On file |
| 19 Apr 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Feb 2019
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Jose A Cruz Gonzalez
22 Jul 2016
21 CFR 211.125(a)
Strict control not exercised over labeling issued
Cited by Cheryl A Clausen
Investigators
FDA investigators tied to this site in the record.
Kham Phommachanh1 insp.
Jose A Cruz Gonzalez1 insp.
Cheryl A Clausen1 insp.
Vlada Matusovsky1 insp.
Sina Shojaee1 insp.
Luis A Dasta1 insp.
Margaret M Annes1 insp.
Katherine Szestypalow1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.130(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.204 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.86 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Otsuka Pharmaceutical Co., Ltd.'s 5 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