# FDA 483 - REACT Innovations - February 17, 2023

Source: https://www.keypedia.com/records/483/react-innovations/37eed089-9ac8-4b94-8c9c-f451a2e206da

> FDA 483 for REACT Innovations on February 17, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: REACT Innovations
- Inspection Date: 2023-02-17
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Magic Race, LLC, a manufacturer in Charlotte, NC, revealed significant deficiencies in its quality system. The firm failed to establish numerous essential procedures, including those for Medical Device Reporting, complaint handling, purchasing controls, corrective and preventive actions, installation, supplier evaluation, quality audits, and management review. These observations indicate a fundamental lack of a documented and implemented quality system.

## Related Officers

- [Gamal A. Norton](https://www.keypedia.com/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

Company: https://www.keypedia.com/companies/react-innovations/69a8229f-d77b-4e4f-bce6-cabeaf2047ad

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7