FDA 483 - Vivify Health, Inc. - February 23, 2024

Vivify Health, Inc. in Richardson, TX, a software manufacturer/developer, was cited with two observations during an FDA inspection from 2/21/2024-2/23/2024. The inspection revealed significant deficiencies in the firm's risk analysis processes, particularly concerning software design interfaces and accessory devices, leading to numerous complaints about inaccurate readings. Additionally, the firm's device software validation was found to be inadequate and incomplete, with substituted test cases and undocumented results, impacting the assurance of device conformity to user needs.