FDA 483 - Ventec Life Systems, Inc. - May 12, 2021

Ventec Life Systems, Inc. in Bothell, WA was inspected, revealing significant deficiencies in its medical device reporting (MDR) procedures. The firm failed to ensure timely and effective evaluation of events that may be subject to reporting requirements, including cases involving patient deaths. Additionally, procedures for corrective and preventive action (CAPA) were found to be inadequately established, lacking specific requirements for documenting risk assessments and supporting calculations.