Overview
- 7 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2023-08-15.
At a glance
Inspections
7
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Aug 2023 – 15 Aug 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 Mar 2020 | Animal Drugs & Feeds | Clean | |
| 29 Oct 2018 – 31 Oct 2018 | Medical Devices & Rad Health | Clean | |
| 11 May 2016 – 13 May 2016 | Human Drugs | Clean | |
| 14 Dec 2012 | Not recorded | Clean | |
| 20 Nov 2009 | Not recorded | Clean | |
| 7 Jul 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Aug 2023
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Colin E Tack
15 Aug 2023
21 CFR 820.72(a)
Calibration, Inspection, etc. Procedures Lack of or Inadequ
Cited by Colin E Tack
Investigators
FDA investigators tied to this site in the record.
Michael R Klapal2 insp.
Colin E Tack1 insp.
Joshua C Schafer1 insp.
Cary Greene1 insp.
Melissa B Libby1 insp.
Phares O Okelo1 insp.
Li Li1 insp.
Tonia F Bernard1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Sterigenics U.S., LLC's 1 Form 483
Source PDFs 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