January 14, 2013 / 6:30 PM / 5 years ago

UPDATE 1-St Jude gets U.S. FDA warning about Sylmar plant

* FDA warning concerns quality system violations

* St Jude says warning not expected to affect orders

* Can address concerns without impact on financial results

* St Jude shares up 1.7 percent

Jan 14 (Reuters) - St Jude Medical Inc said it received a warning letter from U.S. health officials concerning manufacturing issues at its Sylmar, California, plant, where it makes cardiac rhythm management devices.

However, the company said it believes it can address FDA’s concerns without a material impact on its financial results.

The company disclosed in October that it might receive such a letter from the U.S. Food and Drug Administration.

In a regulatory filing on Monday, St Jude said the FDA had noted in the Jan. 11 letter that it would not approve certain new product applications until the quality system violations were corrected.

The letter does not identify any specific concerns about the performance of the company’s Riata ST Optim or Durata defibrillator leads or any other product, St Jude said. Leads are wires that connect implantable defibrillators to the heart.

Riata leads were recalled in 2011 after insulation defects were found. The company stopped selling the Riata leads in late 2010, but thousands remain implanted in patients.

FDA has recommended post-market studies of the Riata lead, as well as St Jude’s newer Durata brand to check for abnormalities.

St Jude said it would continue manufacturing and shipping products from the Sylmar facility and that customer orders were not expected to be affected while it works to resolve the FDA’s concerns.

St Jude shares were up 1.7 percent at $38.96 in afternoon trading on the New York Stock Exchange.

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