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 corrected.
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 concerns.