Jan 14 St Jude Medical Inc said it had
received a warning letter from U.S. health officials concerning
manufacturing issues at its Sylmar, California, plant, where it
makes cardiac rhythm management devices.
In October, the company disclosed 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 letter that it would not approve certain new
product applications until the quality system violations were
The letter does not identify any specific concerns about the
performance of the company's Riata ST Optim or Durata leads or
any other St Jude Medical product, the company said.
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