Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-01.
At a glance
Inspections
8
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Apr 2026 – 1 May 2026 | Medical Devices & Rad Health | Clean | |
| 24 Oct 2022 – 28 Oct 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Jun 2019 – 20 Jun 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Jan 2017 – 13 Jan 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Oct 2015 – 23 Oct 2015 | Medical Devices & Rad Health | WL | On file |
| 4 Sep 2013 – 12 Sep 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 Sep 2009 | Not recorded | Clean | |
| 26 Jul 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Oct 2022
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by Jude C Dike, Lindsey L Kirsh
28 Oct 2022
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by Jude C Dike, Lindsey L Kirsh
28 Oct 2022
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by Jude C Dike, Lindsey L Kirsh
28 Oct 2022
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by Jude C Dike, Lindsey L Kirsh
28 Oct 2022
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by Jude C Dike, Lindsey L Kirsh
Investigators
FDA investigators tied to this site in the record.
Marc S Neubauer2 insp.
Brittany L Carpenter1 insp.
Jude C Dike1 insp.
Lindsey L Kirsh1 insp.
Daniel T Lee1 insp.
Jacob M Dyer1 insp.
Marcus A Ray1 insp.
Joseph A Morkunas1 insp.
Cynthia A Harris1 insp.
Merideth K Rose1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Terumo Medical Corporation'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