Overview
- 12 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-01.
At a glance
Inspections
12
Form 483s
2
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Jul 2025 – 1 Aug 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 27 Jul 2021 | Medical Devices & Rad Health | Clean | |
| 21 Sep 2017 – 22 Sep 2017 | Medical Devices & Rad Health | Clean | |
| 6 Apr 2017 – 12 Apr 2017 | Biologics | Clean | |
| 22 Jun 2015 – 23 Jun 2015 | Biologics | Clean | |
| 15 Jan 2014 | Medical Devices & Rad Health | Clean | |
| 28 Aug 2013 – 13 Sep 2013 | Biologics | 483 | View 483 → |
| 25 Jun 2012 | Not recorded | Clean | |
| 6 Dec 2011 | Not recorded | Clean | |
| 22 Sep 2011 | Not recorded | Clean | |
| 17 Mar 2011 | Not recorded | Clean | |
| 25 Mar 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Aug 2025
21 CFR 820.80(d)
Lack of or inadequate final acceptance procedures
Cited by Tyler R Courtney
1 Aug 2025
21 CFR 820.80(d)
Lack of or inadequate final acceptance procedures
Cited by Tyler R Courtney
13 Sep 2013
21 CFR 1271.160(b)(1)
Ensuring appropriate core requirements followed
Cited by Kellie L Thommes
Investigators
FDA investigators tied to this site in the record.
Marissa S Steinhagen2 insp.
Melissa D Kalik2 insp.
Kellie L Thommes2 insp.
Tyler R Courtney1 insp.
Benjamin W Anderson1 insp.
Joseph D Gong1 insp.
Marissa S Henning1 insp.
Aaron L Dunbar1 insp.
Sandra Sejdinovic1 insp.
James A Beaulieu1 insp.
Timothy R Marrs1 insp.
Ivan E Reyes1 insp.
Yehualashe A Gessesse1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 1271.160(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.160(b)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.200(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 1271.230(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind STERIS Laboratories, 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