# FDA 483 - CSI Medical, INC dba Boyd Corporation - November 18, 2022

Source: https://www.globalkeysolutions.net/records/483/csi-medical-inc-dba-boyd-corporation/3826400f-5c26-4bb8-8bae-4630897bdd37

> FDA 483 for CSI Medical, INC dba Boyd Corporation on November 18, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSI Medical, INC dba Boyd Corporation
- Inspection Date: 2022-11-18
- Product Type: device
- Office Name: New Orleans District Office
- Summary: An FDA inspection of CSI Medical, INC dba Boyd Corporation in Gallatin, TN, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately control nonconforming products, lacking proper documentation for evaluation, disposition, and justification for use. Additionally, procedures for corrective and preventive actions were not adequately established or verified for effectiveness, indicating a systemic breakdown in quality assurance processes.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/csi-medical-inc-dba-boyd-corporation/605c6b00-30da-40f9-8b38-dfc90bc7cfdf

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea