Overview
- 9 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-04.
At a glance
Inspections
9
Form 483s
2
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Jun 2026 – 4 Jun 2026 | Medical Devices & Rad Health | Clean | |
| 15 Aug 2023 – 16 Aug 2023 | Medical Devices & Rad Health | Clean | |
| 24 Feb 2020 – 25 Feb 2020 | Medical Devices & Rad Health | Clean | |
| 13 Mar 2017 – 17 Mar 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Dec 2013 – 6 Dec 2013 | Medical Devices & Rad Health | Clean | |
| 4 Sep 2012 | Not recorded | 483 | On file |
| 7 Dec 2011 | Not recorded | Clean | |
| 27 Jan 2010 | Not recorded | Clean | |
| 9 Jan 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Mar 2017
21 CFR 820.50(a)(3)
Acceptable supplier records, inadequate records
Cited by Jesse A Vazquez
17 Mar 2017
21 CFR 820.50(a)(3)
Acceptable supplier records, inadequate records
Cited by Jesse A Vazquez
Investigators
FDA investigators tied to this site in the record.
Jesse A Vazquez2 insp.
Chad E Schmear1 insp.
Natasha R Johnson1 insp.
Nicholas Z Lu1 insp.
Christopher D Leach1 insp.
Bruce H Mccullough1 insp.
Joseph A Morkunas1 insp.
Debra I Love1 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 820.50(a)(3) | Cited across public-safe Form 483 observations | 3x |
Full site report
Get the verbatim findings behind Sterigenics U.S., LLC'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