Company
Korea (the Republic of)GS Medical Co., Ltd., Cheongju, Korea (the Republic of) – FDA Inspections
Inspection records and compliance data for GS Medical Co., Ltd. in Cheongju. 5 FDA inspections on record, 3 Form 483s, last inspected June 18, 2026.
Company Profile
This profile covers GS Medical Co., Ltd. based in Cheongju, Korea (the Republic of).
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 3
- Warning letters
- 0
First inspected December 13, 2012. Last inspected June 18, 2026.
Most cited issue areas
- Individual Report of Malfunction2 inspections
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Complaints1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 18, 2026 | Not classified | Medical Devices & Rad Health | 1323448 |
| February 1, 2024 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1228226 |
| August 10, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1023134 |
| November 17, 2016 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 994657 |
| December 13, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 811881 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
GS Medical Co., Ltd.
FEI Number
3005596514
Address
Osong-Eup, Heungdeok, 90 Osongsaengmyeong4-Ro; Heungdeok, Cheongju, Korea (the Republic of)
Country
Korea (the Republic of)
ID: 9b9a353c-0fce-496d-83f0-79b79032cb40