Overview
- 14 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-29.
At a glance
Inspections
14
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Apr 2026 – 29 Apr 2026 | Biologics | 483 | View 483 → |
| 11 Jan 2024 – 16 Jan 2024 | Biologics | 483 | View 483 → |
| 19 Nov 2018 – 28 Nov 2018 | Biologics | Clean | |
| 14 Oct 2016 – 24 Oct 2016 | Biologics | Clean | |
| 20 Jan 2016 – 27 Jan 2016 | Biologics | Clean | |
| 3 Dec 2013 – 13 Dec 2013 | Biologics | Clean | |
| 24 Jan 2013 – 20 Feb 2013 | Human Drugs | 483 | On file |
| 30 Jul 2012 | Not recorded | Clean | |
| 15 Jul 2010 | Not recorded | Clean | |
| 7 Jun 2006 | Not recorded | Clean | |
| 12 Feb 2004 | Not recorded | Clean | |
| 5 Sep 2002 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Jan 2024
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Creighton T Tuzon, Eric Zhu
Investigators
FDA investigators tied to this site in the record.
Yvonne C Wilkes4 insp.
Maurine Fadlalla1 insp.
Creighton T Tuzon1 insp.
Eric Zhu1 insp.
Michael D Garcia1 insp.
Ana Djurdjevic1 insp.
Laverne Kimble1 insp.
Lawrence H Howell1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.10(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.10(g)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Children's Hospital of Orange County's 3 Form 483s
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