# FDA 483 - Diamond Orthopedic - April 05, 2019

Source: https://www.keypedia.com/records/483/diamond-orthopedic/d7fb6055-5d3d-4e6a-bdc8-a6e65f187549

> FDA 483 for Diamond Orthopedic on April 05, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Diamond Orthopedic
- Inspection Date: 2019-04-05
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Diamond Orthopedic in Charlotte, NC, a medical device manufacturer, revealed 11 significant quality system deficiencies. The firm failed to adequately manage complaints, control nonconforming products, establish proper CAPA procedures, and maintain accurate device history records. These issues indicate systemic problems in ensuring product quality and regulatory compliance.

## Related Officers

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

Company: https://www.keypedia.com/companies/diamond-orthopedic/e28b03bc-db63-466d-8b13-325955b11544

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