Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2021-11-19.
At a glance
Inspections
6
Form 483s
2
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Nov 2021 – 19 Nov 2021 | Medical Devices & Rad Health | Clean | |
| 31 Aug 2015 – 11 Sep 2015 | Foods & Cosmetics | 483 | View 483 → |
| 15 Oct 2013 – 8 Nov 2013 | Human Drugs | Clean | |
| 30 Nov 2011 | Not recorded | WL | |
| 14 May 2010 | Not recorded | 483 | On file |
| 18 Apr 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Sep 2015
21 CFR 56.108(a)(1)
Initial and continuing reviews
Cited by Jennifer C Adams, Jennifer C Johnson
Investigators
FDA investigators tied to this site in the record.
Jeanne J Thai1 insp.
Yuanyuan Li1 insp.
Colleen E Burke1 insp.
Jennifer C Adams1 insp.
Jennifer C Johnson1 insp.
Marcia A Worley1 insp.
Bradley J Maunder1 insp.
Margaret Torres-Vazquez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 56.108(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.108(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.113 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Advocate Health Care IRB'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