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FDA Sends St. Jude Warning Letter Over Calif. Plant

Tue, 01/15/2013 - 9:33am
The Associated Press

WASHINGTON (AP) -- Medical device maker St. Jude Medical said Monday it received a warning letter from the Food and Drug Administration about manufacturing and quality-control problems at a California plant where it makes implantable heart defibrillators.

The company said in a regulatory filing that it is working to correct the problems at its Sylmar, Calif., plant and does not expect the citation to impact its financial results.

The warning was expected after St. Jude announced in October that the plant had been visited by FDA inspectors. The staffers found inconsistencies in how the company manufactured and documented defibrillators, which are devices implanted in the chest to correct dangerous heart rhythms.

St. Jude said it is working to fix the problems cited by the government. Under the terms of the warning letter, the FDA will not approve any new product lines to be manufactured at the plant until the problems are corrected.

However, the company said FDA is not asking the company to recall any of its products. St. Jude also said it can continue manufacturing and shipping products from the facility.

St. Jude, which is based in St. Paul, Minn., has struggled in recent years to address quality issues with wires that are used to attach the defibrillator to the heart.

St. Jude stopped selling its Riata wires in late 2010 because of concerns about their insulation, and it recalled the devices in late 2011. Last year the company recalled two other wires, QuickSite and QuickFlex. Around 79,000 Riata leads are implanted in U.S. patients, and the FDA ordered St. Jude to conduct a three-year study to learn more about the risk of insulation failure.

Shares of St. Jude Medical rose 56 cents to $38.85 in trading.

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