St. Jude Medical Inc., a maker of heart defibrillators for irregular heartbeats, said it received a warning from U.S. regulators about manufacturing and quality-control problems 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 recent filing. 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.
In an effort to calm the FDA’s concerns, St. Jude sent a 34-page letter to the FDA, on Nov. 7, acknowledging mistakes and promising to make improvements and bolster training. They also sent the FDA a list of corrective actions the company is taking.
The company said the FDA is not asking the company to recall any of its products. St. Jude also said it can continue manufacturing and shipping products from the facility. 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 products 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.
The company also said in the regulatory filing that because it is working to correct the problems at its plant they do not expect the citation to affect its financial results.
The Cause of St. Jude Medical Warning
The warning was expected after St. Jude announced in October that the FDA inspectors had visited the plant. The FDA inspectors visited the facility from Sept. 25 to Oct. 17, 2012. The inspection raised several concerns with regulators, prompting them to file what is called a Form 483 detailing alleged violations at the facility. For example, the Form 483 cited concerns over such things as the number of tests performed on Durata leads and the facility’s record-keeping. The staffers found inconsistencies in how the company manufactured and documented defibrillators, devices implanted in the chest to correct dangerous heart rhythms.
St. Jude, based in St. Paul, Minn., has struggled in recent years to address quality issues with wires used to attach the defibrillator to the heart.
St. Jude stopped selling its Riata wires in late 2010 because of concerns about their insulation, and it recalled the devices in late 2011. Last year the company recalled two other wires, QuickSite and QuickFlex. Around 79,000 Riata leads are implanted in U.S. patients, and the FDA ordered St. Jude to conduct a three-year study to learn more about the risk of insulation failure.