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

Source: https://www.keypedia.com/records/eir/compass-health-brands-corporate-office/dea1bf8d-d071-440f-af90-21bb85af5e44

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

---

## Details

- Record Type: EIR
- Company Name: Compass Health Brands (Corporate Office)
- Inspection Date: 2021-10-07
- Product Type: devices
- Office Name: Chicago District Office
- Summary: An FDA inspection of Compass Health Brands Corp., a medical device initial importer, complaint handling unit, and distributor, was conducted from September 16 to October 7, 2021. The inspection, initiated as a follow-up to a Class I recall, focused on compliance with medical device regulations (per compliance program 7382.845). At the inspection's conclusion, an FDA-483 was issued to the company's President and CEO, Stuart J. Straus, detailing several significant observations. Main violations included the late reporting of a Class I correction and removal to the FDA (21 CFR 806.10(b)) and inadequate corrective and preventive action (CAPA) activities (21 CFR 820.100(b)). Specifically, the firm's corrective actions for adjustable bath seats involved in serious injuries were found insufficient, and supplier corrective actions for overheating devices were not adequately managed. The inspection also identified incomplete risk analyses (21 CFR 820.30(g)) and a lack of established design change procedures (21 CFR 820.30(i)) for Class II devices where the company holds 510(k)s. Furthermore, inadequate control over supplier changes to specifications (21 CFR 820.50), with approvals occurring after implementation and conflicting documentation, was cited. A verbal observation was also made regarding the incomplete information provided to foreign manufacturers for medical device reporting. All observations were met with a commitment to correct by the CEO.

## Related Documents

- [483 - 2021-10-07](https://www.keypedia.com/records/483/compass-health-brands-corporate-office/f16ce976-19f4-4b7c-add6-5773d10043f2)
- [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/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669