Overview
- 6 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2019-03-11.
At a glance
Inspections
6
Form 483s
1
EIRs
2
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Mar 2019 – 11 Mar 2019 | Biologics | Clean | |
| 22 May 2017 – 26 May 2017 | Biologics | Clean | |
| 25 Jan 2013 | Not recorded | 483 | View 483 → |
| 13 Aug 2010 | Not recorded | Clean | |
| 24 Apr 2008 | Not recorded | Clean | |
| 2 Jun 2004 | 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.
Geoffrey K Kilili2 insp.
Yvette M Lacour-Davis1 insp.
Jennifer L Jager1 insp.
Dell S Moller1 insp.
Hugh M Mcclure1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 50.52 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.115(a)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Nationwide Children's Hospital 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