GE halts U.S. imports of mammography and radiation therapy after FDA letter

July 17, 1996

Agency found fault with GMP documentationGE Medical Systems has suspended shipments of mammography andradiation therapy systems into the U.S. after receiving a warningletter from the Food and Drug Administration regarding good

Agency found fault with GMP documentation

GE Medical Systems has suspended shipments of mammography andradiation therapy systems into the U.S. after receiving a warningletter from the Food and Drug Administration regarding good manufacturingpractices at the Buc Cedex, France, facility where the systemsare manufactured.

The Milwaukee vendor halted the shipments June 24 after receivingthe warning letter, according to GE spokesperson Peg Ireland.The letter was the result of an FDA inspection of the plant inlate February and early March.

The FDA every two to three years inspects manufacturing facilitiesoutside the U.S. whose products are imported into the country,in order to confirm that they are adhering to GMP guidelines.In GE's case, the FDA claimed that the Buc facility was remissin some of its documentation procedures, such as records thattrack parts sent to the facility from other vendors. The FDA didnot find fault with any of the products manufactured by the facility,according to Ireland.

"None of this has to do with product issues," Irelandsaid. "It's all about the manufacturing process documentation."

GE acquired the Buc facility when it bought Thomson-CGR in1987 (SCAN 8/5/87). The factory is ISO 9001-certified and manufacturesall of GE's mammography and radiation therapy systems, Irelandsaid. Manufacturing of mammography and radiation therapy systemswill continue at the plant, as will shipments to countries apartfrom the U.S.

"We will ship to other nations," Ireland said. "TheFDA regulations are very specific to the U.S."

GE has not indicated how much the suspension will cost thecompany in revenue. It will certainly affect the company's U.S.market share, where GE historically had the largest position inthe modality until last year, when Trex Medical acquired BennettX-Ray to add to its Lorad division.

GE received FDA 510(k) clearance several months ago for itsnewest mammography systems, Senographe 700-T and Senographe 800-T(SCAN 3/27/96). The import suspension will undoubtedly complicateGE's marketing plans for these products.

GE responded to the FDA's warning letter on July 3, and isnow awaiting word from the FDA on when it can resume shipments,Ireland said. The company does not know how long it will takethe agency to respond.