FDA Inspection
GS Medical Co., Ltd.GS Medical Co., Ltd. – FDA Inspection, Nov 17, 2016
Record Details
This FDA Inspection record concerns GS Medical Co., Ltd., with an inspection on November 17, 2016, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
View Company Profile
ID · cd9a4dca-88e2-4e3e-a6a4-1d56b5c44357
Inspection Facts
- Inspection number
- 994657
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Complaints
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 | |
| February 1, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 10, 2017 | VAI | Center for Devices and Radiological Health | 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.