# FDA 483 - Cancer Diagnostics Inc. - April 04, 2025

Source: https://www.globalkeysolutions.net/records/483/cancer-diagnostics-inc/8f25d2e3-25ec-44ce-84a5-f73f838fd26e

> FDA 483 for Cancer Diagnostics Inc. on April 04, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cancer Diagnostics Inc.
- Inspection Date: 2025-04-04
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Cancer Diagnostics Inc. in Durham, NC, was inspected by the FDA from April 2-4, 2025, and received six observations, many of which were repeat findings from a 2019 inspection. The firm demonstrated significant deficiencies across its Quality Management System, including failures in CAPA, design control, purchasing control, complaint handling, internal audits, and management review. These issues indicate a systemic lack of implementation for critical quality procedures for their Class II medical devices.

## Related Documents

- [483 - 2019-08-14](https://www.globalkeysolutions.net/records/483/cancer-diagnostics-inc/56307f8f-4ec3-4097-a650-696502f192b5)

## Related Officers

- [Jamie P. Webb](https://www.globalkeysolutions.net/people/jamie-p-webb/9e052469-54f7-4d56-b977-27babbdac09b)

Company: https://www.globalkeysolutions.net/companies/cancer-diagnostics-inc/ef947024-368f-4873-9a27-4932f8c85eb7

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