FDA inspections in the fall of 2012 at the Sylmar facility, which makes St. Jude’s Durata defibrillator leads, turned up 11 problems with quality control and documentation procedures.
The FDA’s warning letter followed a Form 483 issued to the St. Paul, Minn.-based medical device company immediately after the inspections.
Today St. Jude said the FDA says the issues cited in the warning letter have been taken care of.
"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," chairman, president & CEO Dan Starks said in prepared remarks. "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."