# FDA 483 - GEO Medical Co., Ltd. - April 13, 2023

Source: https://www.globalkeysolutions.net/records/483/geo-medical-co-ltd/84d57ec4-da5d-4754-9213-951e56ad42b1

> FDA 483 for GEO Medical Co., Ltd. on April 13, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GEO Medical Co., Ltd.
- Inspection Date: 2023-04-13
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of GEO Medical Co., Ltd. in Gwangju, Korea, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately validate processes after facility relocation, establish proper procedures for handling customer complaints, conduct thorough corrective and preventive actions, and maintain adequate design review records for their contact lenses. These observations indicate systemic issues in their quality management.

## Related Officers

- [Jude C. Dike](https://www.globalkeysolutions.net/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.globalkeysolutions.net/companies/geo-medical-co-ltd/22bd135e-206f-48aa-b91f-784475bb262c

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd