GE Medical Systems appears to have satisfied the Food and Drug Administration's concerns regarding deficient procedures at the vendor's manufacturing facility in Buc, France, where GE manufactures the Senographe 2000D full-field digital mammography system.
After receiving a response from GE, the FDA informed the company in a June 1 letter that all open issues included in its April 10 warning letter had been addressed, GE spokesman Patrick Jarvis told AuntMinnie.com.
In the warning letter, the FDA's Center for Devices and Radiological Health said a December inspection of the Buc facility revealed that "the methods used in, or the facilities or controls used for the manufacturing, packing, storage, or installation, are not in conformance with the Quality System regulations for Medical Device regulations."
The warning letter, which requested further documentation of procedures, did not affect manufacturing or delivery of any systems, Jarvis said.
By AuntMinnie.com staff writersAugust 10, 2001
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GE gets warning letter for Senographe 2000D, April 25, 2001
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