# FDA 483 - Keranetics Inc. - February 06, 2025

Source: https://www.keypedia.com/records/483/keranetics-inc/49e209af-8b2c-4b46-9eac-a08246b26055

> FDA 483 for Keranetics Inc. on February 06, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Keranetics Inc.
- Inspection Date: 2025-02-06
- Product Type: other
- Office Name: Atlanta District Office
- Summary: Keranetics Inc. in Winston Salem, NC, a specification developer, was inspected by the FDA from February 5-6, 2025. The inspection revealed significant deficiencies in the firm's quality system, including a lack of written Medical Device Reporting (MDR) procedures, inadequate complaint handling, failure to conduct management reviews, and absence of quality audits. These findings indicate a broad failure to maintain essential quality system controls.

## Related Officers

- [Christopher B. May](https://www.keypedia.com/people/christopher-b-may/b2173a59-d37b-41f1-aa39-eefd854722b8)

Company: https://www.keypedia.com/companies/keranetics-inc/e81a83f4-9b6e-4578-86db-b1271860314d

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