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Thoratec Corp Does not Expect FDA Letter will Materially Impact Company's Financials


Thoratec Corporation (NASDAQ: THOR) received a Warning Letter from the U.S. Food and Drug Administration on January 4, 2012. The Warning Letter relates to the late filing of two Medical Device Reports by Thoratec, which were originally discussed in a Form 483 issued by FDA after an inspection of the Company's California manufacturing facilities in August and September 2011. The Company takes these matters seriously and expects to respond to the FDA's requests within the required time frame. Following the receipt of the Form 483, we provided written responses to the FDA detailing proposed preventive and corrective actions and immediately initiated efforts to address FDA's observations. The FDA Warning Letter indicates that, with respect to the Form 483 observations unrelated to MDRs, Thoratec's responses provided during and after the inspection appeared to be adequate. The Company believes that the FDA's concerns set forth in the Warning Letter can be resolved without a material impact to the Company's financial results. In particular, we do not expect either customer orders or our ability to manufacture or ship products to be impacted by the Warning Letter.

View filing here.

Posted-In: News FDA


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