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St. Jude Warning Letter Adds More Pressure On Firm’s Leads Division

The company stresses that FDA’s letter does not identify any specific concerns about Durata or any other product, but the citation nonetheless states that the leads are “adulterated” due to quality system violations and “misbranded” due to adverse event reporting lapses.

A Jan. 10 FDA warning letter

alleges St. Jude Medical Inc.’s committed quality system violations at the Sylmar, Calif. facility that produces Durata and Riata ST Optim implantable defibrillator leads.

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