FDA Inspection
GEO Medical Co., Ltd.GEO Medical Co., Ltd. – FDA Inspection, Aug 20, 2026
Record Details
This FDA Inspection record concerns GEO Medical Co., Ltd., with an inspection on August 20, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 2363a1f1-3f4b-41aa-aecc-15273367a39e
Inspection Facts
- Inspection number
- 1331744
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 4.1.4Changes to the QMS not adequately controlled or evaluated
- ISO 13485:2016 Clause 6.4.1Work environment requirements and procedures not documented
- ISO 13485:2016 Clause 8.3.1Records of nonconforming product and actions taken not maintained
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Other FDA inspections of GEO Medical Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 13, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 31, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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