07.02.14
St. Paul, Minn.-based medical device giant St. Jude Medical Inc. has resolved a U.S. Food and Drug Administration (FDA) warning letter it received a year ago. The letter was issued after an inspection of a St. Jude California plant that manufactures ICD (implantable cardioverter defibrillator) leads that turned up violations that the company did not address to the FDA’s satisfaction. In addition to numerous manufacturing, testing and documentation deficiencies, the letter stated that the company failed to report within 30 days malfunctions relating to Durata leads that “would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.”
“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 Chairman, President and CEO Dan Starks. “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.”
“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 Chairman, President and CEO Dan Starks. “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.”