Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-05-19.
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 |
|---|---|---|---|
| 18 May 2023 – 19 May 2023 | Medical Devices & Rad Health | Clean | |
| 15 May 2018 | Medical Devices & Rad Health | 483 | On file |
| 19 Apr 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Jul 2012 | Not recorded | Clean | |
| 25 Mar 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Apr 2016
21 CFR 1030.10(c)(3)(i)
tests--errors and uncertainties accounted for
Cited by Michael P Sweeney, Joseph C Teixeira
Investigators
FDA investigators tied to this site in the record.
Andre S Lamontagne2 insp.
Joseph C Teixeira2 insp.
Gregory M Bessette1 insp.
Nassim Ben Makhlouf1 insp.
Michael P Sweeney1 insp.
Emir Galevi1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 1030.10(c)(3)(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Samsung Electronics' 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