FDA 483 - Accriva Diagnostics, Inc. - January 18, 2019

An FDA inspection of Accriva Diagnostics, Inc. in San Diego revealed significant deficiencies in their quality system for the Signature Elite Microcoagulation System. The firm failed to adequately investigate numerous complaints, including those linked to serious patient injuries, and lacked proper procedures for finished device acceptance and process validation. Additionally, issues were identified with design verification not meeting input requirements and inadequate documentation of design inputs, particularly regarding critical temperature controls.