FDA officially warns St. Jude Medical for California plant


St. Jude Medical confirmed Monday that it received a warning letter from the U.S. Food and Drug Administration regarding quality-control issues found at a California facility where it makes its controversial Durata defibrillator leads, Reuters reports.

The Little Canada-based medical device maker says the letter does not identify any issues related to the performance of the leads or any other St. Jude Medical device.

St. Jude announced that it might receive such a letter last fall after federal inspections at the plant in September and October.

Last week, St. Jude sent federal regulators a letter promising a series of improvements.

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FDA approves new St. Jude Medical defibrillators

The Food and Drug Administration okayed the Little Canada-based company's Assura portfolio of implantable cardioverter defibrillators and cardiac resynchronization therapy devices. The new line is said to have "advanced sensing options designed to reduce the incidence of inappropriate shocks."