# FDA 483 - SurGenTec, LLC - April 18, 2019

Source: https://www.globalkeysolutions.net/records/483/surgentec-llc/c008e4c5-e8bd-4515-9db2-c9e97d753984

> FDA 483 for SurGenTec, LLC on April 18, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SurGenTec, LLC
- Inspection Date: 2019-04-18
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Surgentec, LLC, a medical device manufacturer in Boca Raton, FL, was inspected by the FDA, revealing significant deficiencies. The inspection identified inadequate procedures for design validation, particularly concerning packaging changes for the Graftgun Universal Graft Delivery System. Additionally, the firm's Medical Device Reporting (MDR) procedures lacked proper documentation and recordkeeping, and corrective and preventive action (CAPA) processes were not adequately established or fully implemented.

## Related Officers

- [Joshua J. Silvestri](https://www.globalkeysolutions.net/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)
- [David M. Wilkinson](https://www.globalkeysolutions.net/people/david-m-wilkinson/5e81ba03-7602-46d6-b675-26efc77d28db)

Company: https://www.globalkeysolutions.net/companies/surgentec-llc/75555d07-66bb-43c4-9fc8-e3dc25aac38a

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6