Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-07-02.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Jun 2025 – 2 Jul 2025 | Medical Devices & Rad Health | Clean | |
| 13 Mar 2017 – 23 Mar 2017 | Medical Devices & Rad Health | Clean | |
| 22 Oct 2013 – 5 Nov 2013 | Human Drugs | 483 | View 483 → |
| 9 Jun 2008 | Not recorded | 483 | On file |
| 9 Sep 2002 | 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.
Jay B Shah1 insp.
Shirley S Wen1 insp.
Byungja E Marciante1 insp.
Krystal O Ogunremi1 insp.
Peter R Lenahan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 56.108(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 56.108(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Newark Beth Israel Med Ctr IRB's 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