The U.S. Food and Drug Administration has announced that it is asking Utah Medical Products, to stop manufacturing and distributing medical devices until the firm has demonstrated that it has corrected deviations from Current Good Manufacturing Practice, as set forth in the Quality System regulation.
The Quality System regulation establishes requirements for the methods, facilities, and controls used in the production of medical devices. Utah Medical manufactures a variety of medical devices used in obstetrics, gynecology, neonatal intensive care, urology, electro-surgery, and blood pressure monitoring.
Failure to comply with the Quality System regulation does not necessarily mean that a particular device will be defective, but a firm's failure to comply with the regulation decreases the level of assurance that its products are safe and effective. "FDA will not tolerate manufacturing practices that can potentially put patients at risk," said FDA Acting Commissioner Dr. Lester M. Crawford. "Patients have a right to expect that the medical devices used to treat them are safe and effective."
The government's complaint was filed by the United States Department of Justice in the U.S. District Court for the District of Utah. In addition to Utah Medical, the complaint names as defendants Kevin L. Cornwell, the Chairman and Chief Executive Officer, and Ben D. Shirley, the Quality Manager and Vice President of Engineering.
The government took this action after a series of FDA inspections over the past three years revealed a pattern of significant deviations from the Quality System regulation at Utah Medical's Midvale facility. During the most recent inspection, conducted between February 3 and March 3, 2004 , FDA investigators found a variety of problems, including the failure to establish that manufacturing processes were adequately controlled, and the failure to have an effective system to identify and correct manufacturing problems.
Despite repeated warnings from the FDA, including a Warning Letter following one of the inspections, Utah Medical has consistently failed to ensure that its products are manufactured in accordance with the Quality System regulation.