Overview
- 11 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-12-13.
At a glance
Inspections
11
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Dec 2024 – 13 Dec 2024 | Biologics | Clean | |
| 26 Jun 2019 – 2 Jul 2019 | Biologics | 483 | View 483 → |
| 2 Mar 2018 – 8 Mar 2018 | Biologics | 483 | On file |
| 17 Feb 2016 – 18 Feb 2016 | Biologics | Clean | |
| 9 Jan 2014 – 15 Jan 2014 | Biologics | 483 | View 483 → |
| 26 Jan 2012 | Not recorded | Clean | |
| 1 Sep 2010 | Not recorded | 483 | View 483 → |
| 27 Jan 2009 | Not recorded | Clean | |
| 10 Mar 2005 | Not recorded | Clean | |
| 11 May 2001 | Not recorded | Clean | |
| 14 Feb 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.
Alice C Silva3 insp.
Sherry M Nisson2 insp.
Jonah S Ufferfilge1 insp.
Alan R Condon1 insp.
Kent A Conforti1 insp.
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 606.100(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 640.3(a)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind North Shore Medical Center's 4 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