# FDA 483 - CAO Group, Inc. - May 07, 2018

Source: https://www.globalkeysolutions.net/records/483/cao-group-inc/6ba7b265-86fa-42bb-95bb-4efcdefd07a1

> FDA 483 for CAO Group, Inc. on May 07, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CAO Group, Inc.
- Inspection Date: 2018-05-07
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of CAO Group, Inc. in West Jordan, UT, revealed severe deficiencies in the conduct and oversight of an investigational device study. The firm initiated a clinical trial without required FDA and IRB approvals, failed to select qualified investigators, and neglected to maintain essential study records. These observations highlight a significant lack of adherence to regulatory requirements for medical device clinical investigations.

## Related Documents

- [483 - 2019-06-05](https://www.globalkeysolutions.net/records/483/cao-group-inc/4674d127-a78d-42fd-85dd-1bafec62bb37)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/vickie-j-kanion/4ec38844-d90f-490e-bdfb-7bcee20fcc90)
- [investigator](https://www.globalkeysolutions.net/people/stephen-t-hansen/7ae1f1df-7f68-4264-bd87-ea21c8d879bb)

Company: https://www.globalkeysolutions.net/companies/cao-group-inc/a9c7ff91-7508-42e6-86aa-d63860b29c2c

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face