Utah Medical Products Inc. continues to fight allegations of a problematic manufacturing process and that its medical devices are somehow defective or unsafe.
On Tuesday, the Midvale-based company again issued a news release saying that it continues to manufacture and distribute all of its products worldwide, without any regulatory restriction.
"Unfortunately, UTMD's competitors," a company statement said, "have tried to take advantage of the situation through innuendo to customers that UTMD may be imminently shut down. This is false."
In August, the U.S. Food and Drug Administration filed a request for a permanent injunction against the company from manufacturing and distributing medical devices.
The FDA's action was the result of an inspection of the company earlier this year in which the agency determined that the methods and controls Utah Medical used in the manufacturing, packing and storing of medical devices were "not in compliance with good manufacturing practice."
A pretrial conference has been set for May 2005 in U.S. District Court to address the government's allegations. A trial could be held as early as June.
"Interestingly, the FDA has not sought a preliminary injunction against UTMD, which would be in the public interest if there were a device quality issue," the company said. "The FDA appears to be in no hurry to have their claims adjudicated."
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