# FDA 483 - Reliance Medical Systems LLC - November 17, 2022

Source: https://www.keypedia.com/records/483/reliance-medical-systems-llc/34b798f4-ddae-46d0-bcc9-ae161460182b

> FDA 483 for Reliance Medical Systems LLC on November 17, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reliance Medical Systems LLC
- Inspection Date: 2022-11-17
- Product Type: device
- Office Name: Denver District Office
- Summary: Reliance Medical Systems LLC, a medical device manufacturer in Bountiful, UT, received a Form FDA 483 with three observations following an inspection. The firm was cited for significant deficiencies including inadequate maintenance of device history records, insufficient documentation and verification of corrective and preventive actions, and a lack of independence for quality audit personnel. These findings indicate a need for substantial improvements in their quality management system.

## Related Officers

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

Company: https://www.keypedia.com/companies/reliance-medical-systems-llc/49453aa4-c12e-4752-9b66-cd5df3c01bc6

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