FDA 483 - Diagnostic Automation/Cortez Diagnostics Inc - July 15, 2021

Diagnostic Automation/Cortez Diagnostics Inc. in Irvine, CA, underwent an FDA inspection from July 13-15, 2021, which revealed a significant deficiency in their process control procedures. The firm failed to adequately establish procedures for recording in-process non-conformities during the relabeling/repacking of Class II IVD kits. This indicates a moderate severity issue related to quality system compliance.