FDA Inspection
GS Medical Co., Ltd.GS Medical Co., Ltd. – FDA Inspection, Aug 10, 2017
Record Details
This FDA Inspection record concerns GS Medical Co., Ltd., with an inspection on August 10, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- GS Medical Co., Ltd.
- Inspection Date
- August 10, 2017
- Product Type
- Devices
View Company Profile
ID · a47176a7-3fbf-480b-9c42-8e32661c8595
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1023134
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
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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 |
| 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 |
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