GE Medical Systems has received a Food and Drug Administration warning letter regarding deficient procedures at the manufacturing facility in Buc, France, where the vendor's Senographe 2000D full-field digital mammography system is manufactured.
In an April 10 letter (see link below), the FDA's Center for Devices and Radiological Health said a December inspection of the 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 letter goes on to cite several deficiencies, along with an evaluation of GE's previous communication with the agency. The vendor has 15 business days within receipt of the correspondence to notify the CDRH of the specific steps it has taken, or will take, to correct the violations, according to the correspondence.
GE is in the process of responding to the letter, which requests further documentation of procedures, spokesperson Patrick Jarvis told AuntMinnie.com.
"We're confident that we can address any of the remaining issues that are in the letter, and don't anticipate future action from the FDA," he said.
By AuntMinnie.com staff writersApril 25, 2001
Links
April 10 letter from CDRH (PDF format)
Download Adobe Acrobat (PDF) reader
Related Reading
Full-field digital mammography offers higher sensitivity, lower doses, March 28, 2001
Film-screen mammography remains gold standard, IOM says, March 8, 2001
Full-field digital mammography is finally ready for prime time, November 16, 2000
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