# FDA 483 - Medfaxx, Inc. - July 10, 2019

Source: https://www.keypedia.com/records/483/medfaxx-inc/29cd3a23-db0a-41d9-b0f7-18b4e57750c6

> FDA 483 for Medfaxx, Inc. on July 10, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medfaxx, Inc.
- Inspection Date: 2019-07-10
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of MedXXX, Inc. in Wake Forest, NC, revealed significant deficiencies in their quality system. The firm failed to establish critical procedures for design control, medical device reporting, corrective and preventive actions, and complaint handling. Additionally, management did not adequately review the quality system's suitability and effectiveness, indicating a broad lack of foundational quality system controls.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/david-e-lowe/1a2492c2-4a81-4486-b3af-37f6b7b5216a)
- [Christopher B. May](https://www.keypedia.com/people/christopher-b-may/b2173a59-d37b-41f1-aa39-eefd854722b8)

Company: https://www.keypedia.com/companies/medfaxx-inc/616e39ee-9a45-474d-8de5-d421a9f77d66

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