Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-07-10.
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 |
|---|---|---|---|
| 8 Jul 2024 – 10 Jul 2024 | Biologics | Clean | |
| 29 Jul 2019 – 2 Aug 2019 | Biologics | Clean | |
| 30 Jan 2017 – 14 Feb 2017 | Biologics | 483 | View 483 → |
| 10 Sep 2014 – 26 Sep 2014 | Biologics | 483 | View 483 → |
| 28 Jul 2010 | Not recorded | Clean | |
| 1 Feb 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Sep 2014
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Alice C Silva, Melinda K Plaisier
26 Sep 2014
21 CFR 606.100(c)
Record review prior to release
Cited by Alice C Silva, Melinda K Plaisier
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 606.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 600.14(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind The Children's Hospital Corporation's 2 Form 483s
Source PDFs, 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