Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2019-04-18.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Apr 2019 – 18 Apr 2019 | Medical Devices & Rad Health | Clean | |
| 18 Mar 2013 – 27 Mar 2013 | Biologics | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Mar 2013
21 CFR 56.108(a)(1)
Initial and continuing reviews
Cited by Lauren E Swantko, Dianna D Wardlow-Dotter
27 Mar 2013
21 CFR 56.115(a)(2)
Minutes of IRB meetings
Cited by Lauren E Swantko, Dianna D Wardlow-Dotter
27 Mar 2013
21 CFR 56.115(a)(6)
Written procedures per 56.108(a) and (b)
Cited by Lauren E Swantko, Dianna D Wardlow-Dotter
Investigators
FDA investigators tied to this site in the record.
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 56.110(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.115(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.115(a)(5) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.115(a)(6) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind St Lukes Health System IRB's 1 Form 483
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