Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-18.
At a glance
Inspections
3
Form 483s
2
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Sep 2025 – 18 Sep 2025 | Human Drugs | Clean | |
| 12 Oct 2021 – 15 Oct 2021 | Human Drugs | 483 | View 483 → |
| 6 Nov 2013 – 4 Dec 2013 | Human Drugs | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Oct 2021
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Michael Serrano, Tyanna N Hadley
15 Oct 2021
21 CFR 314.80(c)(2)
Late submission of quarterly safety reports
Cited by Michael Serrano, Tyanna N Hadley
Investigators
FDA investigators tied to this site in the record.
Gene R Gunn1 insp.
Ashley J Burns1 insp.
Michael Serrano1 insp.
Tyanna N Hadley1 insp.
Christina N Maurino1 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 | 1x |
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Mitsubishi Tanabe Pharma America, 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