Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2017-03-22.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Mar 2017 – 22 Mar 2017 | Medical Devices & Rad Health | 483 | On file |
| 21 Apr 2016 – 22 Apr 2016 | Medical Devices & Rad Health | 483 | On file |
| 17 Sep 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Sep 2012
21 CFR 820.70(a)
Process control procedures, Lack of or inadequate procedures
Cited by Christine M Parmentier
17 Sep 2012
21 CFR 820.80(b)
Lack of or inadequate receiving acceptance procedures
Cited by Christine M Parmentier
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SIEMENS LTD SEOUL's 3 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