St. Jude Warning Letter Adds More Pressure On Firm’s Leads Division
This article was originally published in The Gray Sheet
The company stresses that FDA’s letter does not identify any specific concerns about Durata or any other product, but the citation nonetheless states that the leads are “adulterated” due to quality system violations and “misbranded” due to adverse event reporting lapses.
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The recall, related to a manufacturing misstep for St. Jude's Optisure defibrillator leads, effects 447 devices and has not been linked to any patient injuries, the firm says.
FDA approval of several St. Jude Medical’s new cardiac rhythm management devices, including a new defibrillator lead, suggest the agency is largely satisfied with the company’s steps to resolve a January 2013 warning letter.