# FDA 483 - Cancer Diagnostics Inc. - August 14, 2019

Source: https://www.globalkeysolutions.net/records/483/cancer-diagnostics-inc/56307f8f-4ec3-4097-a650-696502f192b5

> FDA 483 for Cancer Diagnostics Inc. on August 14, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cancer Diagnostics Inc.
- Inspection Date: 2019-08-14
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Carver Diagnostics Inc. in Durham, NC, a medical device specification developer and repacker/relabeler, revealed six significant deficiencies in its quality system. The firm failed to establish or adequately implement procedures for critical areas such as design control, purchasing, medical device reporting, statistical techniques, quality audits, and management review, indicating a broad lack of compliance with regulatory requirements.

## Related Documents

- [483 - 2025-04-04](https://www.globalkeysolutions.net/records/483/cancer-diagnostics-inc/8f25d2e3-25ec-44ce-84a5-f73f838fd26e)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/david-e-lowe/1a2492c2-4a81-4486-b3af-37f6b7b5216a)
- [Melanie W. Pishnery](https://www.globalkeysolutions.net/people/melanie-w-pishnery/ff4846b0-ffe1-4df0-9116-4bb238866b3a)

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