St. Jude Medical, Inc., a global medical device company, announced that it has been notified by the U.S. Food and Drug Administration (FDA) that issues cited in the Sylmar, Calif., facility’s warning letter have been addressed.
“We take our responsibility as a medical device manufacturer very seriously. We are encouraged by the resolution of the FDA’s warning letter and will continue to work to ensure the highest standards are met across our manufacturing facilities,” said Dan Starks, Chairman, President and Chief Executive Officer at St. Jude Medical. “St. Jude Medical is committed to providing our patients, customers and regulators with products and services that meet or exceed their expectations of safety, high-quality performance, reliability and service.”