FDA Voices Concern Over St. Jude (STJ) Durata Lead Testing; Shares Fall
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St. Jude (NYSE: STJ) is getting hit Wednesday following criticism from the FDA over the company's Durata defibrillator leads.
The FDA said that St. Jude failed to follow proper inspection procedures at its Irvine, California-based facility. The FDA inspection was date from September 25th through October 17th.
This morning, Wells Fargo downgraded the stock to Market Perform from Outperform. The firm said, in part, "We think the issues raised in the FDA 483 inspection letter are likely to heighten physicians' concerns about Durata because the letter highlights flaws in the design verification and validation methods for the lead."
Shares of St. Jude are over 14 percent lower on heavy volume.
The FDA said that St. Jude failed to follow proper inspection procedures at its Irvine, California-based facility. The FDA inspection was date from September 25th through October 17th.
This morning, Wells Fargo downgraded the stock to Market Perform from Outperform. The firm said, in part, "We think the issues raised in the FDA 483 inspection letter are likely to heighten physicians' concerns about Durata because the letter highlights flaws in the design verification and validation methods for the lead."
Shares of St. Jude are over 14 percent lower on heavy volume.
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