# FDA 483 - Plus EV Holdings, Inc. - December 12, 2024

Source: https://www.keypedia.com/records/483/plus-ev-holdings-inc/181c18f1-3511-431d-918e-2a93b82031b4

> FDA 483 for Plus EV Holdings, Inc. on December 12, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Plus EV Holdings, Inc.
- Inspection Date: 2024-12-12
- Product Type: device
- Office Name: Kansas City District Office
- Summary: An FDA inspection of Plus EV Holdings, Inc. in North Kansas City, MO, from December 11-12, 2024, revealed a significant lack of established and documented design controls for Class II medical devices. The firm failed to perform and document essential design control activities, including design inputs, reviews, verification, and validation, for distributed vaginal dilators and kegel exercise systems. This indicates a serious deficiency in the firm's quality system regarding product development and release.

## Related Officers

- [Eric C. Fox](https://www.keypedia.com/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)

Company: https://www.keypedia.com/companies/plus-ev-holdings-inc/bc637fde-d1ca-4ac1-bade-45bc8e0140ee

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79