Medtronic's Physio-Control external defibrillator unit must clean up wide-ranging quality systems problems under an April 25 consent decree with FDA. The decree, filed in the U.S. District Court for the Western District of Washington, bars Physio-Control from selling its LifePak external defibrillators until certain condition are met. The agreement cites the firm for various violations, including deviations in design control, production and process control, corrective and preventive actions (CAPA), and complaint handling. Among a litany of requirements under consent decree, Physio-Control must hire an outside expert to certify that corrections are made, document steps the firm has taken to identify the root causes of external defibrillator failures that occurred during the two years prior to the decree, and report to FDA within 90 days on the procedures it will follow when recalling devices in the future. Once the company achieves a satisfactory FDA follow-up inspection, the firm must retain an independent auditor to perform facility inspections annually and report to the agency for four years. If the firm fails to comply with any of the decree's provisions or timelines, it will face a fine of $15,000 per business day while it is in violation, up to $20 million per year
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