In what is likely to be one of this decade's most closely watched trials in the medtech industry, Utah Medical Products Inc. (UTMD; Midville, UT) and FDA will meet in the U.S. District Court in Salt Lake City at the end of this month to settle a long-standing dispute over the company's compliance with the agency's quality system regulation (QSR).
Following a number of inspections of UTMD's Midville plant dating back to 2002, FDA cited UTMD as having demonstrated a pattern of consistent disregard for the QSR. The agency reported finding "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." Several warning letters were issued.
