St. Jude Medical, a maker of medical devices, said Monday that it had received a warning letter from federal regulators concerning manufacturing issues at its Sylmar, Calif., plant, where it makes cardiac rhythm management products.
In a regulatory filing, St. Jude said the Food and Drug Administration 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 plant, and that customer orders were not expected to be affected while it works to resolve the F.D.A.'s concerns.
In October, the company disclosed that it might receive such a letter from the F.D.A.
F.D.A. Warns St. Jude Medical
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F.D.A. Warns St. Jude Medical
