# FDA 483 - Geodong Medical Co - May 03, 2018

Source: https://www.keypedia.com/records/483/geodong-medical-co/f285089b-c4dc-4f40-be8d-3f8a36f893c1

> FDA 483 for Geodong Medical Co on May 03, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Geodong Medical Co
- Inspection Date: 2018-05-03
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Geodong Medical Co in Busan, Korea, from April 30 to May 3, 2018, revealed multiple significant deficiencies in its quality system. The firm failed to adequately document design inputs, establish acceptance criteria for validation, and conduct thorough risk analyses. Additionally, there were critical shortcomings in complaint handling, Medical Device Reporting (MDR) procedures, corrective and preventive actions, nonconforming product control, and labeling activities, indicating a broad lack of compliance with regulatory requirements.

## Related Officers

- [Mary A. Millner](https://www.keypedia.com/people/mary-a-millner/bd8911cf-849d-41d2-ae12-dd4bad66e798)

Company: https://www.keypedia.com/companies/geodong-medical-co/3bc44364-bef9-4e54-9ec0-0b15b65c619c

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