GE responds to warning letter regarding digital mammography unit

May 9, 2001

The FDA has warned GE Medical Systems that certain procedures surrounding the manufacture, packaging, and shipping of GE’s digital mammography system are not adequate. The allegations, made in an April 10 warning letter, followed a routine

The FDA has warned GE Medical Systems that certain procedures surrounding the manufacture, packaging, and shipping of GE’s digital mammography system are not adequate. The allegations, made in an April 10 warning letter, followed a routine inspection in December of the Buc Cedex, France, plant where the Senographe is manufactured. Also allegedly deficient were procedures regarding employee training involving Senographe 2000D, the only full-field digital mammography system cleared for sale in the U.S.

The warning letter gave GE 15 working days to respond, and the company crafted a response to the FDA, describing how it will correct the alleged violations and the steps that will be taken to prevent such problems in the future. GE expected to adequately address all the FDA’s concerns about the system, according to spokesperson Patrick Jarvis.

“We will respond within the allotted time,” said Jarvis, who indicated that the company had until May 2. “Once we compile the documentation the FDA is requesting, we do not anticipate any further action.”

The Buc Cedex plant is the only site that manufactures the Senographe 2000D, which gained FDA clearance last year. Responding to the FDA’s concerns should not affect the company’s ability to deliver units, Jarvis said.

“It is something we take seriously,” Jarvis said. “But we don’t anticipate any effect on production.”

Warning letters are not to be taken lightly, but they seldom have long-lasting deleterious effects on any company receiving one. In most cases, as in this one, they cite procedural problems that might affect the operation of the device. There is usually no proof, however, that the problems cited in the letter have affected or will affect the function of the medical device.

The warning letter sent to GE was written by Larry D. Spears, acting director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. It indicated that deficiencies at the Buc Cedex plant might reflect serious underlying problems in the company’s manufacturing and quality assurance programs. The letter identified eight specific deficiencies related to the manufacture, packaging, storage, or installation of the Senographe 2000D, as outlined in the FDA’s Quality System Regulations. The letter acknowledged that GE had already responded adequately to alleged deficiencies involving procedures for implementing corrective and preventive action, service reporting, and shipping validation.

Still to be corrected are procedures that ensure appropriate documentation of design requirements and changes, training, translation of inspection reports and test instructions from French into English, and submission of copies of validated corrective and preventive actions.