Overview
- 9 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-24.
At a glance
Inspections
9
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Jun 2026 – 24 Jun 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Jun 2021 – 10 Jun 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Jan 2017 – 26 Jan 2017 | Human Drugs | Clean | |
| 11 Jan 2016 – 14 Jan 2016 | Medical Devices & Rad Health | Clean | |
| 17 Dec 2013 – 20 Dec 2013 | Medical Devices & Rad Health | Clean | |
| 7 Sep 2012 | Not recorded | Clean | |
| 2 Dec 2010 | Not recorded | 483 | View 483 → |
| 8 Apr 2009 | Not recorded | Clean | |
| 26 Oct 1999 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Jun 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Wendy M Stone
2 Dec 2010
21 CFR 820.75(c)
Process changes - review, evaluation and revalidation
Cited by Catherine M Beer
Investigators
FDA investigators tied to this site in the record.
Chad N Thompson2 insp.
Wendy M Stone1 insp.
Jacqueline S Warner1 insp.
Rajiv R Srivastava1 insp.
Juan R Jimenez Garcia1 insp.
Nicholas C Mendiola1 insp.
Satheesh Thomas1 insp.
Catherine M Beer1 insp.
Paul E Stein1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sterigenics U.S., LLC's 3 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