# FDA 483 - Ev Rider, LLC - March 05, 2019

Source: https://www.keypedia.com/records/483/ev-rider-llc/f5300e52-714a-471a-866b-83f4503a5193

> FDA 483 for Ev Rider, LLC on March 05, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ev Rider, LLC
- Inspection Date: 2019-03-05
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Ev Rider, LLC in Fort Myers, FL, an initial importer and own label distributor of motorized mobility vehicles, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures for receiving, reviewing, and evaluating complaints, and also lacked written Medical Device Reporting (MDR) procedures. These issues indicate a failure to ensure proper handling of complaints and timely reporting of adverse events for their medical devices.

## Related Officers

- [investigator](https://www.keypedia.com/people/stanley-b-eugene/4708f43e-0592-4c24-b276-d9f9092788a3)

Company: https://www.keypedia.com/companies/ev-rider-llc/dec851d1-49bb-4b40-9847-20b87a42be7b

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