UPDATE 1-St. Jude Medical gets FDA warning on 2 facilities

Thu Jul 2, 2009 3:46pm EDT
 
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* Says letter related to manufacturing practices

* Says concerns can be resolved without material impact

* Sees no impact on customer orders

* Says initiated efforts to address FDA's concerns

* Shares down 3 pct

July 2 (Reuters) - Medical devices maker St. Jude Medical Inc (STJ.N) said it received a warning letter from U.S. health regulators on manufacturing practices at two of its facilities.

The company said it initiated efforts to address the U.S. Food and Drug Administration's concerns and said the warning is not expected to impact customer orders.

The letter dated June 26 said the FDA would not grant requests for exportation certificates to foreign governments, nor clear pre-market approval applications for the company's class III devices until the violation are corrected, St. Jude said.

The FDA identified certain non-conformities with Current Good Manufacturing Practice, the company said in a regulatory filing.

The company said its Neuromodulation division provided written responses to the FDA detailing proposed corrective actions at its Plano, Texas and Hackettstown, New Jersey facilities. St. Jude said it believes the FDA's concerns can be resolved without a material impact on the company's financial results.

Shares of the Saint Paul, Minnesota-based company were down 3 percent at $39.47 in late afternoon trade on the New York Stock Exchange. (Reporting by Vidya L Nathan in Bangalore; Editing by Vinu Pilakkott)

 

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