Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-03-30.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Mar 2023 – 30 Mar 2023 | Human Drugs | 483 | View 483 → |
| 13 Feb 2020 – 21 Feb 2020 | Human Drugs | 483 | On file |
| 13 Feb 2020 – 21 Feb 2020 | Human Drugs | 483 | On file |
| 17 Feb 2020 – 19 Feb 2020 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Mar 2023
21 CFR 211.68(b)
Backup data not assured as exact and complete
Cited by Melanie W Pishnery, Marcellinus D Dordunoo
30 Mar 2023
21 CFR 211.84(b)
Representative Samples
Cited by Melanie W Pishnery, Marcellinus D Dordunoo
Investigators
FDA investigators tied to this site in the record.
Wayne E Seifert2 insp.
Virginia A Carroll2 insp.
Melanie W Pishnery1 insp.
Marcellinus D Dordunoo1 insp.
Stephen R Souza1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind TERUMO YAMAGUCHI CORPORATION's 3 Form 483s
Source PDFs 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