Overview
- 7 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-11-20.
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 |
|---|---|---|---|
| 25 Sep 2025 – 20 Nov 2025 | Biologics | 483 | View 483 → |
| 7 Nov 2022 – 10 Nov 2022 | Biologics | Clean | |
| 27 Aug 2018 – 28 Aug 2018 | Biologics | Clean | |
| 22 Jan 2015 – 26 Jan 2015 | Biologics | Clean | |
| 10 Dec 2012 | Not recorded | Clean | |
| 19 Jan 2011 | Not recorded | Clean | |
| 11 Jun 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
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 606.170(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.60(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind St Louis Children's Hospital's 1 Form 483
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