Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-03-30.
At a glance
Inspections
6
Form 483s
3
EIRs
4
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Mar 2016 – 30 Mar 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Aug 2015 – 1 Sep 2015 | Medical Devices & Rad Health | Clean | |
| 19 Mar 2013 – 26 Mar 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Jul 2009 | Not recorded | Clean | |
| 25 Jul 2008 | Not recorded | 483 | On file |
| 23 Mar 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Mar 2016
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Matthew M Vernon, Amanda S Zorn
Investigators
FDA investigators tied to this site in the record.
Amanda S Zorn3 insp.
Thai T Duong2 insp.
Matthew M Vernon1 insp.
Janet Pulver1 insp.
Bryan J Love1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sorin Group USA, Inc.'s 3 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