Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-13.
At a glance
Inspections
7
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Feb 2026 – 13 Feb 2026 | Human Drugs | 483 | On file |
| 9 Sep 2019 – 13 Sep 2019 | Human Drugs | 483 | On file |
| 12 Mar 2018 – 16 Mar 2018 | Human Drugs | 483 | View 483 → |
| 13 Jun 2016 – 17 Jun 2016 | Human Drugs | 483 | On file |
| 21 Dec 2012 | Not recorded | 483 | On file |
| 7 Oct 2009 | Not recorded | 483 | On file |
| 1 Feb 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Mar 2018
21 CFR 211.166(a)(3)
Valid stability test methods
Cited by Jason R Caballero, Vioela J Caze
Investigators
FDA investigators tied to this site in the record.
Jose R Hernandez2 insp.
Tamil Arasu1 insp.
Cheryl A Clausen1 insp.
Jason R Caballero1 insp.
Vioela J Caze1 insp.
Sandra A Hughes1 insp.
Javier O Vega1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.166(a)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind MicroBiopharm Japan Co., Ltd.'s 6 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