Overview
- 11 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2024-08-02.
At a glance
Inspections
11
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 Jul 2024 – 2 Aug 2024 | Biologics | Clean | |
| 10 Jan 2020 – 16 Jan 2020 | Biologics | Clean | |
| 6 Feb 2018 – 12 Feb 2018 | Biologics | Clean | |
| 22 Jan 2016 – 27 Jan 2016 | Biologics | Clean | |
| 29 Jan 2014 – 6 Feb 2014 | Biologics | Clean | |
| 19 Sep 2012 | Not recorded | Clean | |
| 14 Apr 2011 | Not recorded | 483 | View 483 → |
| 17 Oct 2008 | Not recorded | Clean | |
| 14 Nov 2002 | Not recorded | Clean | |
| 24 Aug 2001 | Not recorded | Clean | |
| 10 Jan 2000 | 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.
Jennifer L Custodio2 insp.
Sarah M Forney2 insp.
Jannet M Peroti1 insp.
Jennifer A Bazergui1 insp.
Jennifer Macmillan1 insp.
Christina N Maurino1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 606.100(b)(14) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 606.171 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Robert Wood Johnson University Hospital Somerset'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