FDA 483 - Unetixs Vascular, Inc. - October 29, 2019

Unetixs Vascular, Inc. received a Form 483 with nine observations detailing significant deficiencies across its quality system. The inspection revealed a systemic lack of adherence to regulations concerning design controls, process controls, corrective and preventive actions, document control, acceptance activities, purchasing controls, training, complaint handling, and quality audits, particularly for its MultiLab® Series ROODRA and LHS vascular diagnostic devices. These issues indicate potential risks to device performance and patient safety due to inadequate manufacturing and quality management practices.