FDA seeks injunction against Utah Medical Products

Manufacturing News, Source : TheManufacturer.com
Published : 16 Aug 2004 15:55

The US Food and Drug Administration announced that it is seeking an injunction to stop Utah Medical Products from manufacturing and distributing medical devices until the firm has demonstrated that it has corrected deviations from FDA manufacturing regulations.

The action was taken 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 Products' facility in Midvale, UT. 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.

The Quality System regulation establishes requirements for the methods, facilities, and controls used in the production of medical devices. 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 in a statement.

The government's complaint was filed by the US Department of Justice in the US District Court for the District of Utah. Utah Medical Products manufactures a variety of medical devices used in obstetrics, gynecology, neonatal intensive care, urology, electrosurgery, and blood pressure monitoring.

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