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Thursday, Sep 21, 2023

FDA Sends St. Jude Sylmar Warning Letter

St. Jude Medical Inc. has received a warning letter from the U.S. Food and Drug Administration regarding manufacturing practices at its Sylmar facility. The letter is a result of an inspection in September and October by the FDA at the San Fernando Valley plant that makes surgically implanted defibrillators and pacemakers. The St. Paul, Minn. medical device manufacturer is correcting the violations outlined in the letter received Jan. 11, the company said in a regulatory filing. The letter did not indicate there were any performance problems or any recalls that needed to be taken with the devices made in Sylmar, according to the regulatory 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,” the filing said. The letter is specific to the Sylmar plant and does impact other St. Jude manufacturing sites. St. Jude employs about 1,500 workers in the Valley location. Layoffs in late 2012 resulted in a loss of more than 200 employees during a period when St. Jude restructured itself amid slumping sales of its heart products.

Mark Madler
Mark Madler
Mark R. Madler covers aviation & aerospace, manufacturing, technology, automotive & transportation, media & entertainment and the Antelope Valley. He joined the company in February 2006. Madler previously worked as a reporter for the Burbank Leader. Before that, he was a reporter for the City News Bureau of Chicago and several daily newspapers in the suburban Chicago area. He has a bachelor’s of science degree in journalism from the University of Illinois, Urbana-Champaign.

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