# FDA 483 - SmartGuard Rx, Inc. - December 12, 2018

Source: https://www.globalkeysolutions.net/records/483/smartguard-rx-inc/40191bef-43f6-4937-93c7-47ba46311909

> FDA 483 for SmartGuard Rx, Inc. on December 12, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SmartGuard Rx, Inc.
- Inspection Date: 2018-12-12
- Product Type: device
- Office Name: Denver District Office
- Summary: SmartGuard Rx, Inc. in Layton, UT, a medical device specification developer, was inspected by the FDA from December 10-12, 2018. The inspection revealed significant deficiencies across multiple quality system areas, including a complete lack of established procedures for MDRs, complaint handling, supplier evaluation, design control, document control, nonconforming product, quality audits, and management review. These findings indicate a fundamental absence of a robust quality system for the SmartGuard Elite device.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/smartguard-rx-inc/586e005d-e99c-471e-bc81-c5accb464a26

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