Overview
- 10 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-26.
At a glance
Inspections
10
Form 483s
5
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Sep 2025 – 26 Sep 2025 | Biologics | Clean | |
| 12 Apr 2023 – 18 Apr 2023 | Biologics | Clean | |
| 12 Dec 2019 – 18 Dec 2019 | Biologics | Clean | |
| 6 Jan 2017 – 20 Jan 2017 | Biologics | 483 | View 483 → |
| 22 Sep 2014 – 1 Oct 2014 | Biologics | Clean | |
| 22 Sep 2014 – 30 Sep 2014 | Biologics | Clean | |
| 17 Oct 2012 | Not recorded | 483 | View 483 → |
| 23 Nov 2011 | Not recorded | 483 | View 483 → |
| 23 Oct 2009 | Not recorded | 483 | View 483 → |
| 28 Feb 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Jan 2017
21 CFR 630.10(g)(2)(ii)
Donor's Acknowledgment - Exculpatory language
Cited by Nikisha M Bolden
Investigators
FDA investigators tied to this site in the record.
Kish Bolden2 insp.
Nikisha M Bolden2 insp.
Erika M Wilkerson2 insp.
Linda M Hoover2 insp.
Gayle S Lawson2 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 606.171 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 630.10(g)(2)(ii) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 606.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 610.47 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.10(e)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.10(g)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 630.40(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Thomas Jefferson University Hospital's 5 Form 483s
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