St. Jude Gets FDA Warning for Manufacturing Violations
St. Jude Medical Inc. (STJ), a maker of devices for irregular heartbeats, said it received a warning from U.S. regulators last week for deviating from unspecified good manufacturing practices at its Sylmar, California, plant.
The Food and Drug Administration warned the company in a Jan. 11 letter, which St. Jude had said Oct. 17 it expected, according to a company filing today. The letter, which wasn’t made publicly available by St. Jude or the government, means the St. Paul, Minnesota-based company won’t be able to gain approval for certain devices until the violations are corrected.
St. Jude sent the FDA a list of corrective actions the company is taking. The warning letter doesn’t affect its Durata cable used for defibrillators or any of the company’s other medical products, the device maker said.
“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,” St. Jude said in the filing.
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