# FDA 483 - Hoveround Corporation - June 14, 2019

Source: https://www.keypedia.com/records/483/hoveround-corporation/5e5e5333-69de-462e-bd1e-6f07b93a7fac

> FDA 483 for Hoveround Corporation on June 14, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hoveround Corporation
- Inspection Date: 2019-06-14
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Hoveround Corporation, a medical device manufacturer in Sarasota, FL, was cited for significant deficiencies in its quality system. The inspection revealed inadequate procedures for corrective and preventive actions, including failures to update risk analyses for serious complaints, and a lack of standardized medical device reporting processes and documentation. Additionally, the firm's device history records were found to be incomplete.

## Related Documents

- [483 - 2025-03-07](https://www.keypedia.com/records/483/hoveround-corporation/3d8d341e-abfa-45e4-b6f3-c78703de55d8)

## Related Officers

- [Joshua J. Silvestri](https://www.keypedia.com/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.keypedia.com/companies/hoveround-corporation/41403658-0145-4eab-a588-575bdbcab7f1

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