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According to the filing, in the letter addressed to the company's Implantable Electronic Systems Division, the FDA described "non-conformities with Current Good Manufacturing Practice at the Company's Implantable Electronic Systems Division's Sylmar, California facility," discovered during inspections of the plant conducted between Sept. 25 and Oct. 17 of last year.
In its SEC filing, St. Jude highlighted the fact that the warning "does not impact any of the Company's other manufacturing facilities" and added: "As previously disclosed by management on its third quarter earnings call on October 17, 2012, this warning letter was expected." Furthermore, St. Jude says that it "immediately initiated efforts to address FDA's observations of non-conformity" when they were discovered after these inspections.
St. Jude also says that because no "specific concerns regarding the performance of, or ... need for any field or other action regarding the Riata ST Optim or Durata leads or any other St. Jude Medical product" were stated in the FDA's letter, it plans to "continue manufacturing and shipping product from the Sylmar facility," and "customer orders are not expected to be affected while we work to resolve the FDA's concerns."
St. Jude promised to provide additional detail on any financial impact of the FDA's actions in its end-of-year earnings conference call, scheduled for Jan. 23.
Shares closed the day up 1.5% at $38.85.