# FDA 483 - CAO Group, Inc. - June 05, 2019

Source: https://www.keypedia.com/records/483/cao-group-inc/4674d127-a78d-42fd-85dd-1bafec62bb37

> FDA 483 for CAO Group, Inc. on June 05, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CAO Group, Inc.
- Inspection Date: 2019-06-05
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of CAO Group, Inc., a medical device manufacturer in West Jordan, UT, revealed significant deficiencies in their quality system. Observations included inadequate procedures for complaint handling, device history record maintenance, corrective and preventive actions, incoming product acceptance, and personnel training documentation. These issues indicate a need for improved adherence to regulatory requirements for medical device manufacturing.

## Related Documents

- [483 - 2018-05-07](https://www.keypedia.com/records/483/cao-group-inc/6ba7b265-86fa-42bb-95bb-4efcdefd07a1)

## Related Officers

- [James R. Montero](https://www.keypedia.com/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

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

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