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This article was originally published in The Gray Sheet

Executive Summary

MITSUBISHI ELECTRIC JAPANESE LINEAR ACCELERATOR FACILITY will be reinspected by FDA on May 24 to determine whether an agency ban on the import of equipment manufactured at the site should be lifted. The inspection of the facility in Amagasaki City, Hyogo, Japan will assess the firm's corrections of good manufacturing practices deficiencies that were observed by FDA during a July inspection and that led to the import alert for all the facility's products ("The Gray Sheet" Nov. 30, p. 11). Although FDA will wait to lift the ban until it reviews the results of the May inspection, the agency recently allowed U.S. imports of certain components of Mitsubishi's linear accelerators. The components are being used to retrofit 55 linear accelerators in the field under a corrective action plan (CAP). The company says that FDA allowed the firm to begin shipping the parts and making field corrections in February even though the agency has not officially approved the CAP. According to Mitsubishi, the components modify the linear accelerator's beam "interlock system." The company maintains that the device has not presented any risks to patients, and it has been informing customers on a monthly basis to operate their linear accelerators according to directions outlined in the operator's manual. The firm expects that FDA will deem the field correction a Class II recall. Mitsubishi has received three warning letters related to the linear accelerator facility. After a hospital in Gary, Indiana complained about problems with the EXL 14 accelerator, the agency issued two warning letters to the firm and placed the EXL 14 on import alert ("The Gray Sheet" June 15, p. 16). FDA's third warning letter was issued after the July inspection. The letter listed the findings that led the agency to expand the import alert to all devices manufactured at the Amagasaki City plant.

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