Federal regulators have warned General Electric Co., Fairfield, Conn., over lax quality control standards at a plant that makes computer software for medical imaging.
The warning letter from the Food and Drug Administration lists a dozen record-keeping violations uncovered at a GE facility in Barrington, Ill., between April and May.
FDA inspectors found that GE did not have procedures for reviewing customer complaints, product changes and other information about its Centricity Imaging software that it used to schedule, manage and archive medical images.
GE responded to the FDA's citation in a June 2 letter, but the company's plan for addressing the problems was "inadequate," according to the warning letter posted to the agency's Web site. The FDA demands the company provide a revised plan within 15 working days "to prevent these violations from recurring."
GE said in a written statement that it "takes the warning letter very seriously, and is actively working on providing the information requested by FDA."