GE Medical barred from importing x-ray, radiation therapy systems from French facility.
This article was originally published in The Gray Sheet
Executive Summary
GE BARRED FROM IMPORT OF X-RAY, RADIATION THERAPY DEVICES FROM FRENCH FACILITY due to good manufacturing practices deficiencies, FDA says in a June 12 warning letter. GE Medical, which ceased shipments of mammography and radiation therapy systems from the Buc Cedex, France facility on June 24, is working on correcting the deficiencies and plans to respond to the letter by July 3, the firm states. FDA's warning letter followed a Feb. 26-March 6 inspection of the plant.