# FDA 483 - SLOPE.IO, INC. - April 18, 2024

Source: https://www.keypedia.com/records/483/slopeio-inc/2e168e88-ef95-4fb3-b0cd-71f91e4d78a7

> FDA 483 for SLOPE.IO, INC. on April 18, 2024. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: SLOPE.IO, INC.
- Inspection Date: 2024-04-18
- Product Type: device
- Office Name: Office of Regulatory Affairs
- Summary: SLOPE.IO, INC. in Glen Allen, VA, a medical device manufacturer, received an FDA Form 483 following an inspection from April 15-18, 2024. The inspection revealed significant and systemic deficiencies in the firm's quality system, primarily due to a lack of established and documented procedures across multiple critical areas. These issues indicate a fundamental failure to implement basic quality management practices, with many procedures not established since 2021.

## Related Documents

- [483 - 2024-04-18](https://www.keypedia.com/records/483/slopeio-inc/a289878c-48d7-471c-8291-a2e6026e7c57)

## Related Officers

- [Tiki Dixon](https://www.keypedia.com/people/tiki-dixon/b3160a2c-ef16-4fa2-b9b9-4c3a0ed17c5b)

Company: https://www.keypedia.com/companies/slopeio-inc/ac8c3afb-159b-454f-adb1-0eeaa1ed5c23

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64