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