Overview
- 5 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-18.
At a glance
Inspections
5
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Jun 2026 – 18 Jun 2026 | Medical Devices & Rad Health | 483 | On file |
| 29 Jan 2024 – 1 Feb 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Aug 2017 – 10 Aug 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Nov 2016 – 17 Nov 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Dec 2012 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
1 Feb 2024
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by David J Gasparovich
1 Feb 2024
21 CFR 820.70(c)
Environmental control Lack of or inadequate procedures
Cited by David J Gasparovich
Investigators
FDA investigators tied to this site in the record.
Lashawn M Elam1 insp.
David J Gasparovich1 insp.
Shafiq Ahadi1 insp.
Akbar J Zaidi1 insp.
Frank J Marciniak1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind GS Medical Co., Ltd.'s 5 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