Overview
- 14 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-07-14.
At a glance
Inspections
14
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 Jul 2021 – 14 Jul 2021 | Medical Devices & Rad Health | Clean | |
| 2 Oct 2019 – 11 Oct 2019 | Medical Devices & Rad Health | Clean | |
| 20 Sep 2017 – 3 Oct 2017 | Medical Devices & Rad Health | Clean | |
| 1 Dec 2016 – 7 Dec 2016 | Medical Devices & Rad Health | Clean | |
| 4 May 2016 – 13 May 2016 | Medical Devices & Rad Health | Clean | |
| 22 Jan 2015 – 30 Jan 2015 | Medical Devices & Rad Health | Clean | |
| 13 Jan 2014 – 17 Feb 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Jul 2013 – 19 Jul 2013 | Medical Devices & Rad Health | Clean | |
| 28 Sep 2012 | Not recorded | 483 | On file |
| 29 Mar 2010 | Not recorded | 483 | View 483 → |
| 11 Aug 2008 | Not recorded | 483 | On file |
| 9 Dec 2005 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
Purchasing controls, Lack of or inadequate procedures
Cited by Sargum C Sood, Thomas A Peter, Kimberly Lewandowski-Walker
Lack of or inadequate process validation
Cited by Sargum C Sood, Thomas A Peter, Kimberly Lewandowski-Walker
Lack of or inadequate procedures
Cited by Sargum C Sood, Thomas A Peter, Kimberly Lewandowski-Walker
Records of complaint investigation
Cited by Sargum C Sood, Thomas A Peter, Kimberly Lewandowski-Walker
Report of Death or Serious Injury
Cited by Kimberly Lewandowski-Walker, Gary D Urbiel Goldner, Charles M Spyr, Ryan J Benedict
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.52(b)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.56 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Terumo Cardiovascular Systems Corporation's 4 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