# FDA 483 - Guard Medical Inc - December 19, 2022

Source: https://www.globalkeysolutions.net/records/483/guard-medical-inc/9dae22d1-9441-4dde-af6f-b0aff01b4e81

> FDA 483 for Guard Medical Inc on December 19, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Guard Medical Inc
- Inspection Date: 2022-12-19
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Guard Medical Inc in Miami, FL, a specification developer, identified an issue with their complaint handling procedures. The firm's complaint procedure, SOP-0019, Rev A, was found to be inadequate as it did not ensure timely investigation of complaints generated by the firm. This indicates a deficiency in the established processes for receiving, reviewing, and evaluating complaints.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

Company: https://www.globalkeysolutions.net/companies/guard-medical-inc/5fabf9e8-ac55-4899-8f27-d1bcd1bcba12

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6