The Food and Drug Administration asked a federal court Aug. 10 to prevent injection molder Utah Medical Products Inc. from making or selling devices until the company fixes manufacturing problems.
The agency took the unusual step because it said the Midvale, Utah-based company has ignored repeated warnings to fix ``significant deviations'' in its manufacturing processes. FDA said the company does not have a system in place to identify and correct manufacturing problems, and does not have adequate quality control.
UM said it will fight the charges and continue making its products, and said it is up to the FDA to prove its case in court. The company said in a lengthy statement that FDA inspectors misrepresented practices in the company's Midvale facility.
``[Utah Medical] has offered to make any reasonable changes in our quality system that the FDA could identify, but they have refused to identify any changes or engage in any dialogue,'' said UM Chairman and Chief Executive Officer Kevin Cornwell.
There were no indications in the FDA statement that it found any safety problems with UM devices.
In February, the company first took the dispute public when it issued a statement calling the FDA investigation ``wasteful'' and inviting Congress to use it as a case study to investigate the agency.
The suit, filed in U.S. District Court in Salt Lake City, also names as defendants Cornwell and Ben Shirley, quality manager and vice president of engineering.
The agency said the company was not following Good Manufacturing Practices, requirements for firms that manufacture medical devices. UM molds proprietary devices for obstetrics, gynecology, neonatal intensive-care and other areas.
FDA said its inspectors have noticed problems at UM for three years. Previously, FDA had blocked the company from exporting to South Korea and Ecuador, prompting UM last year to sue for export licenses.
UM said the dispute stems from a 2001 decision by the company not to hire an outside quality systems consultant, despite being urged to by agency inspectors.