Overview
- 13 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-12-03.
At a glance
Inspections
13
Form 483s
1
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Dec 2025 – 3 Dec 2025 | Human Drugs | Clean | |
| 7 Apr 2025 – 8 Apr 2025 | Biologics | Clean | |
| 24 Oct 2022 – 25 Oct 2022 | Medical Devices & Rad Health | Clean | |
| 3 Mar 2021 – 4 Mar 2021 | Medical Devices & Rad Health | Clean | |
| 16 Oct 2019 – 21 Oct 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Aug 2019 – 26 Aug 2019 | Human Drugs | Clean | |
| 10 Jul 2017 – 11 Jul 2017 | Biologics | Clean | |
| 17 May 2017 – 19 May 2017 | Medical Devices & Rad Health | Clean | |
| 12 Jun 2014 | Human Drugs | Clean | |
| 6 Nov 2013 – 8 Nov 2013 | Medical Devices & Rad Health | Clean | |
| 12 Aug 2011 | Not recorded | Clean | |
| 19 Aug 2009 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Gamal A Norton5 insp.
Jose F Velez1 insp.
David E Lowe1 insp.
June P Page1 insp.
Brentley S Collins1 insp.
Dawn M Braswell1 insp.
Eileen J Bannerman1 insp.
Perry H Gambrell1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Sterigenics US, LLC's 1 Form 483
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