FDA slaps St. Jude Medical with warning letter

January 14, 2013 by MassDevice staff

St. Jude Medical says the FDA hit it with a warning letter last week over problems at the Sylmar, Calif., plant that makes its next-generation Durata defibrillator leads.

St. Jude Medical warning letter

St. Jude Medical (NYSE:STJ) said today that the FDA slapped it with a warning letter over problems with the Sylmar, Calif., plant where its keystone Durata defibrillator leads are manufactured.

The St. Paul, Minn.-based medical device company shrugged off the formal warning letter, which follows 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.

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