The Food and Drug Administration is seeking a permanent injunction against Utah Medical Products, Midvale, barring the company from continuing to manufacture its devices used in urology, obstetrics and gynecology, neonatal intensive care, electrosurgery, and blood-pressure monitoring. The FDA said Utah Medical repeatedly failed to comply with good manufacturing practices over the past three years, despite a series of inspections and a warning letter. At the most recent inspection between Feb. 3 and March 3, the FDA said investigators found a variety of problems, including failure to ensure adequate control of manufacturing processes and failure to have a system to detect and correct problems. Utah Medical said it had not yet been served with the complaint but strongly denied the charges, which it said did not pertain to the safety or effectiveness of its devices. The company "welcomes the opportunity to seek the discovery it has been denied for over three years," Utah Medical officials said in a news release. -- by Cinda Becker
FDA seeks to block Utah firm from making devices
Send us a letter
Have an opinion about this story? Click here to submit a Letter to the Editor, and we may publish it in print.