Overview
- 11 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-24.
At a glance
Inspections
11
Form 483s
2
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Feb 2026 | Foods & Cosmetics | Clean | |
| 8 Dec 2025 – 11 Dec 2025 | Medical Devices & Rad Health | Clean | |
| 16 Aug 2023 – 17 Aug 2023 | Medical Devices & Rad Health | Clean | |
| 17 Aug 2022 – 23 Aug 2022 | Human Drugs | 483 | View 483 → |
| 4 Jun 2018 | Foods & Cosmetics | Clean | |
| 6 Dec 2016 – 7 Dec 2016 | Medical Devices & Rad Health | Clean | |
| 2 Dec 2015 – 4 Dec 2015 | Human Drugs | Clean | |
| 18 Mar 2014 – 20 Mar 2014 | Medical Devices & Rad Health | Clean | |
| 13 Apr 2010 | Not recorded | 483 | View 483 → |
| 15 Nov 2007 | Not recorded | Clean | |
| 13 Dec 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
23 Aug 2022
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Patty P Kaewussdangkul, Charles D Brown, Timothy H Vo, Brittny C Cargo
23 Aug 2022
21 CFR 211.198(a)
Procedures to be written and followed
Cited by Patty P Kaewussdangkul, Charles D Brown, Timothy H Vo, Brittny C Cargo
23 Aug 2022
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Patty P Kaewussdangkul, Charles D Brown, Timothy H Vo, Brittny C Cargo
13 Apr 2010
21 CFR 820.100(a)(3)
Identification of actions needed
Cited by Charles D Brown, Trina K Vick
Investigators
FDA investigators tied to this site in the record.
Katlin N Stubbs2 insp.
Patty P Kaewussdangkul2 insp.
Charles D Brown2 insp.
Adam C Hipko1 insp.
Elizabeth A Krolczyk1 insp.
Timothy H Vo1 insp.
Brittny C Cargo1 insp.
State Agency1 insp.
Elizabeth D Connell1 insp.
Roy Baby1 insp.
Trina K Vick1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(3) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sterigenics US, 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