Overview
- 15 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-09-26.
At a glance
Inspections
15
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Sep 2024 – 26 Sep 2024 | Biologics | Clean | |
| 14 Feb 2022 – 16 Feb 2022 | Medical Devices & Rad Health | Clean | |
| 27 Oct 2021 – 3 Nov 2021 | Human Drugs | Clean | |
| 9 Apr 2018 – 10 Apr 2018 | Medical Devices & Rad Health | Clean | |
| 18 Apr 2017 | Medical Devices & Rad Health | Clean | |
| 11 Jan 2016 – 14 Jan 2016 | Human Drugs | 483 | On file |
| 10 Jun 2015 | Medical Devices & Rad Health | Clean | |
| 12 Mar 2013 – 13 Mar 2013 | Medical Devices & Rad Health | Clean | |
| 17 Apr 2012 | Not recorded | Clean | |
| 8 Jul 2010 | Not recorded | Clean | |
| 16 Nov 2009 | Not recorded | 483 | On file |
| 19 Nov 2008 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
14 Jan 2016
21 CFR 211.68(b)
Backup file not maintained
Cited by Liming Zhang, Yasamin Ameri, Darren S Brown
14 Jan 2016
21 CFR 211.68(b)
Backup file not maintained
Cited by Liming Zhang, Yasamin Ameri, Darren S Brown
Investigators
FDA investigators tied to this site in the record.
Sonya L Karsik3 insp.
Jocelyn E Massey2 insp.
John A Gonzalez2 insp.
Creighton T Tuzon1 insp.
Maurine Fadlalla1 insp.
Kevin N Tran1 insp.
Bryan A Galvez1 insp.
Hung H Do1 insp.
Liming Zhang1 insp.
Yasamin Ameri1 insp.
Darren S Brown1 insp.
Linda Thai1 insp.
Lanita F Kelley1 insp.
Cntrctmntr Kelley1 insp.
Steven E Porter1 insp.
Carla J Lundi1 insp.
Jinnie Kokiatkulkij1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Sterigenics U.S., LLC's 2 Form 483s
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