Overview
- 9 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-04-15.
At a glance
Inspections
9
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Apr 2025 – 15 Apr 2025 | Biologics | Clean | |
| 13 Feb 2020 – 18 Feb 2020 | Biologics | Clean | |
| 29 Nov 2017 – 1 Dec 2017 | Biologics | Clean | |
| 7 Jan 2016 – 12 Jan 2016 | Biologics | Clean | |
| 24 Feb 2014 – 27 Feb 2014 | Biologics | Clean | |
| 11 Sep 2012 | Not recorded | 483 | View 483 → |
| 9 Jul 2010 | Not recorded | Clean | |
| 18 Jun 2010 | Not recorded | 483 | View 483 → |
| 4 Jun 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Sep 2012
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Michele M Falchek
18 Jun 2010
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Nikisha M Bolden, Julianne C Mccullough
18 Jun 2010
21 CFR 606.100(b)
Establish, maintain and follow manufacturing SOPs
Cited by Nikisha M Bolden, Julianne C Mccullough
18 Jun 2010
21 CFR 606.160(a)(1)
Person performing, test results, interpretation
Cited by Nikisha M Bolden, Julianne C Mccullough
18 Jun 2010
21 CFR 606.170(a)
Adverse reaction - Maintenance of Reports
Cited by Nikisha M Bolden, Julianne C Mccullough
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 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.160(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.170(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Temple University Hospital - Jeanes Campus' 2 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