The U.S. Food and Drug Administration said Friday it has reached an agreement with GE OEC Medical Systems, Inc. to correct manufacturing deficiencies in its X-ray surgical imaging systems at its plants in Salt Lake City, Utah, and Lawrence, Mass.
GE is prohibited to manufacture or distribute those systems until the problem with the FDA’s current good manufacturing practice (CGMP) requirements has been resolved.
An inspection of the Utah facility from 2004 showed infractions of the CGMP requirements and resulted in a warning letter to GE on March 31, 2005. The current action stems from inspections between July 31 and August 29, 2006, in which, according to the FDA, GE had not shown an adequate response to the FDA’s request for corrections.
The X-ray systems are used during diagnostic, surgical and interventional procedures, like orthopedic, cardiac, critical-care and emergency room procedures, among others.
“These devices are used on thousands of patients, and their dependability and accuracy are critical for the successful outcomes of important medical procedures,” said Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Heath. “When FDA’s August 2006 inspection found ongoing CGMP deficiencies at the Utah facility, GE voluntarily stopped distributing devices from that facility and is working with FDA to ensure that necessary corrective actions are fully implemented.”
