# FDA 483 - CDB Corporation - September 12, 2019

Source: https://www.keypedia.com/records/483/cdb-corporation/8d600cac-a65f-4e05-af8f-c630abb5c827

> FDA 483 for CDB Corporation on September 12, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CDB Corporation
- Inspection Date: 2019-09-12
- Product Type: device
- Office Name: Atlanta District Office
- Summary: CDB Corporation, a manufacturer of dental brackets in Leland, NC, was cited with six observations during an FDA inspection. The inspection revealed significant deficiencies in their quality system, particularly concerning documentation in Device History Records, process validation, and complaint handling. These issues indicate a lack of control over manufacturing processes and product quality.

## Related Officers

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

Company: https://www.keypedia.com/companies/cdb-corporation/6c64b75e-1be4-4237-aed1-c4ccfebf8258

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