St. Jude Medical seesaws on FDA warning letter

January 15, 2013 by MassDevice staff

Wall Street investors send shares of St. Jude Medical up yesterday and down today after the company reveals a warning letter from the FDA over its Sylmar, Calif., Durata defibrillator lead plant.

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A warning letter from the FDA to St. Jude Medical (NYSE:STJ) sent the St. Paul, Minn.-based medical device company's stock on a seesaw ride yesterday and today.

STJ shares closed up 1.5% yesterday at $38.85 each after St. Jude revealed the warning letter, but closed down 1.2% today at $38.39 apiece.

 

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St. Jude shrugged off the formal warning letter, which followed a so-called "Form 483" from the federal watchdog agency detailing 11 problems with quality control and documentation procedures at the Sylmar facility.

"As previously disclosed by management on its 3rd-quarter earnings call on Oct. 17, 2012, this warning letter was expected," St. Jude said today in a regulatory filing. "The FDA letter notes that it will not grant requests for exportation certificates to foreign governments or approve pre-market approval applications for Class III devices to which the quality system regulation deviations are reasonably related until the violations have been corrected. The warning letter does not, however, identify any specific concerns regarding the performance of, or indicate the need for any field or other action regarding, the Riata ST Optim or Durata leads or any other St. Jude Medical product," according to the filing. "Accordingly, the Company will continue manufacturing and shipping product from the Sylmar facility and customer orders are not expected to be impacted while we work to resolve the FDA's concerns."

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