FDA Inspection
GEO Medical Co., Ltd.GEO Medical Co., Ltd. – FDA Inspection, Jan 31, 2013
Record Details
This FDA Inspection record concerns GEO Medical Co., Ltd., with an inspection on January 31, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- GEO Medical Co., Ltd.
- Inspection Date
- January 31, 2013
- Product Type
- Devices
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ID · c4a60609-d443-4994-aa87-783aae9c7098
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 817938
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of GEO Medical Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 13, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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