# FDA 483 - Organ Eco Tech - February 27, 2020

Source: https://www.globalkeysolutions.net/records/483/organ-eco-tech/749e3647-4f0e-45eb-8acb-6489c0ad8276

> FDA 483 for Organ Eco Tech on February 27, 2020. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Organ Eco Tech
- Inspection Date: 2020-02-27
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Nuvexel Co. Ltd., a manufacturer of Class 2 spinal fixation systems in Seongnam-si, Korea, was inspected by the FDA and received a Form 483 with four observations. The inspection revealed significant deficiencies in their quality system, including inadequate procedures for corrective and preventive actions, calibration, design review, and document control. These issues indicate a lack of robust controls over critical manufacturing and quality processes.

## Related Officers

- [Stephen R. Souza](https://www.globalkeysolutions.net/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)

Company: https://www.globalkeysolutions.net/companies/organ-eco-tech/5b1b3243-3a2a-4938-8563-cd0a935529da

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