St. Jude Medical's Little Canada headquarters
The medical device giant said it would make improvements to its processes and address specific concerns raised during an inspection of its Sylmar, California facility.
January 9, 2013
Little Canada-based St. Jude Medical, Inc., said in a letter to the U.S. Food and Drug Administration (FDA) that it will make a number of improvements to address concerns raised by regulators following an inspection of one of its facilities.
The company’s manufacturing plant in Sylmar, California, was inspected by regulators in October. At the plant, St. Jude makes cardiac rhythm management products, which include pacemakers, defibrillators, and leads—wires that connect defibrillators to the heart. St. Jude’s Durata leads were at the center of the recent FDA inspection.
St. Jude’s defibrillator leads have come under scrutiny in recent years: The company recalled its Riata line of leads in 2011 amid reports of their failure. The company then launched its Durata line, claiming that the new leads were designed to prevent the problems seen in the older ones. (Last year, a physician reported to the FDA that one of the Durata leads failed after it was implanted in a patient, although St. Jude said it analyzed that particular lead and found it did not have the same flaw as the Riata leads.)
St. Jude CEO Dan Starks in October said during the company’s third-quarter earnings call that he expected to receive a warning from the FDA following the facility inspection. About a week later, St. Jude confirmed that it had received a “Form 483” from regulators. (A Form 483 notifies companies of “objectionable conditions” that were observed during inspections, and companies are encouraged to respond with plans to correct the problems.)
St. Jude’s response to the FDA is dated November 7, although it was only recently made public by the FDA. In its letter, the company said it will make improvements to its overall processes. For example, St. Jude said it would provide additional education for its staff, make improvements “to ensure robust process for the design and development of our products and processes,” and improve its risk management processes to enhance monitoring and control of its systems.
It also made promises to address specific problems raised by the FDA, including some related to its Durata lead, although a significant number of details are redacted from the letter. In one instance, the FDA complained that St. Jude failed to adhere to its own policies regarding the testing of its Durata product. The agency also said St. Jude’s risk analysis of the Durata design is “inadequate” because it combines recalled devices with those that are still on the market. In its response, the company vowed to resolve the issues and said it has already begun implementing changes.
To read St. Jude’s letter, click here.
“It doesn’t mean the product is bad, but it means they have some work to do,” David Furr, an Austin, Texas-based consultant who reviewed the inspection report and has never worked for St. Jude, recently told The Wall Street Journal.
St. Jude is Minnesota’s 15th-largest public company based on revenue, which totaled $5.6 billion in its most recent fiscal year.
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