FDA Inspection
GS Medical Co., Ltd.GS Medical Co., Ltd. – FDA Inspection, Dec 13, 2012
Record Details
This FDA Inspection record concerns GS Medical Co., Ltd., with an inspection on December 13, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- GS Medical Co., Ltd.
- Inspection Date
- December 13, 2012
- Product Type
- Devices
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ID · cda15c48-5f31-496c-8847-e9e8a72090b0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 811881
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.30(g)Design validation - documentation
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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 |
| August 10, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 17, 2016 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
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