St. Jude Prepares for Warning Letter as New Details Emerge on Durata 483
St. Jude Medical is bracing for an FDA warning letter over quality problems in the manufacturing processes for the company’s Durata implantable cardioverter defibrillators (ICD). However, the company does not expect to recall the products.
Durata leads are marketed as a safer replacement for the company’s Riata leads, which were pulled from the market in December 2011 due to a design flaw that caused insulation to erode prematurely.
FDA inspections of two St. Jude facilities in September and October have resulted in Form 483s for the company’s Sylmar, Calif., and Arecibo, Puerto Rico, facilities. The company said it will not be surprised if they result in a warning letter.
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