FDA Inspection
GS Medical Co., Ltd.GS Medical Co., Ltd. – FDA Inspection, Feb 1, 2024
Record Details
This FDA Inspection record concerns GS Medical Co., Ltd., with an inspection on February 1, 2024, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 91dbb86d-bdcf-422a-a0e7-bc787f17b69d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1228226
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of GS Medical Co., Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 18, 2026 | Not classified | Office of Inspections and Investigations | |
| August 10, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 17, 2016 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
| December 13, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for GS Medical Co., Ltd.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.