# FDA 483 - NeuroVention, LLC - May 31, 2023

Source: https://www.globalkeysolutions.net/records/483/neurovention-llc/85ae6c5e-1f20-4a14-b066-60f54ba926ad

> FDA 483 for NeuroVention, LLC on May 31, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NeuroVention, LLC
- Inspection Date: 2023-05-31
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of NeuroVention, LLC in Daytona Beach, FL, a manufacturer of the Neurovention Cranial Fixation System (Class II), revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, lacking requirements for data analysis and complete CAPA documentation. Additionally, procedures for internal quality audits were not properly established or followed, with audits not being performed as required and conducted by individuals with direct responsibility for the audited matters.

## Related Officers

- [Monica C. Burgos Garcia](https://www.globalkeysolutions.net/people/monica-c-burgos-garcia/d73d6ad6-4158-4c12-a0bf-6f5721db3400)

Company: https://www.globalkeysolutions.net/companies/neurovention-llc/557599ec-5ae1-4290-bfab-ebf182abaa73

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