# FDA 483 - Nexus CMF, LLC - September 25, 2019

Source: https://www.keypedia.com/records/483/nexus-cmf-llc/ed69c3a7-6c68-458b-8527-6f4fa5f7e381

> FDA 483 for Nexus CMF, LLC on September 25, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nexus CMF, LLC
- Inspection Date: 2019-09-25
- Product Type: device
- Office Name: Denver District Office
- Summary: Nexus CMF, LLC, a medical device specification developer in Cottonwood Heights, UT, was cited with five observations during an FDA inspection. The firm demonstrated significant deficiencies in its quality system, including inadequate procedures and documentation for complaint handling, corrective and preventive actions, nonconforming product control, personnel training, and supplier evaluation. These issues indicate a systemic failure to adhere to established quality system requirements.

## Related Officers

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

Company: https://www.keypedia.com/companies/nexus-cmf-llc/55768276-0646-4b4a-aab0-8faf00a15af6

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