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Drug & Device News
FDA Takes X-Ray Manufacturer to Task
GE OEC Medical Systems Inc. in January signed a consent decree of permanent injunction prohibiting it from manufacturing or distributing X-ray machines from its Salt Lake City and Lawrence, MA, facilities. The X-ray systems previously manufactured at these locations were used during diagnostic, surgical, and interventional procedures, such as orthopedic, cardiac, critical-care and emergency room procedures.
The FDA issued its initial Warning Letter to the company in March 2005 following an inspection that revealed violations of the FDA's current good manufacturing practice (CGMP) requirements as set forth in the Quality System (QS) regulation for devices. When a second inspection in 2006 showed the previously-reported problems continued ' including failure to establish and maintain adequate procedures for validating the device design and failure to establish and maintain adequate procedures for implementing corrective and preventive actions ' the FDA imposed this more stringent enforcement action. The decree will require GE OEC Medical Systems to hire an independent expert to conduct inspections of the affected facilities and to certify to the FDA that corrections have been made before manufacturing and distribution may resume.
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