# FDA 483 - Compass Health Brands (Corporate Office) - October 07, 2021

Source: https://www.keypedia.com/records/483/compass-health-brands-corporate-office/f16ce976-19f4-4b7c-add6-5773d10043f2

> FDA 483 for Compass Health Brands (Corporate Office) on October 07, 2021. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Compass Health Brands (Corporate Office)
- Inspection Date: 2021-10-07
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: The FDA inspection of Compass Health Brands (Corporate Office) in Middleburg Heights, OH, identified seven significant violations related to quality system regulations for medical devices. The firm failed to timely report a Class I recall, inadequately documented corrective actions for serious injuries and safety issues, and exhibited deficiencies in risk analysis, design change procedures, and supplier management. These issues indicate a lack of robust controls over product quality and safety across various device types.

## Related Documents

- [483 - 2022-12-19](https://www.keypedia.com/records/483/compass-health-brands-corporate-office/b22625d2-9e10-4ac5-8c38-872c78fccb79)

## Related Officers

- [Investigator ](https://www.keypedia.com/people/benjamin-j-dastoli/688c2ad7-f7ac-47eb-8ca2-4efcd221f636)

Company: https://www.keypedia.com/companies/compass-health-brands-corporate-office/92693a8a-f91c-4fad-80cd-e738ccc48fc0

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22