St. Jude Addresses Regulators’ Concerns At Mftg. Plant
St. Jude Medical said Wednesday that it has resolved concerns that federal regulators raised about one of its manufacturing plants.
In late 2012, the U.S. Food and Drug Administration (FDA) sent a “Form 483” to Little Canada-based St. Jude, outlining “11 observations” about the company's manufacturing plant in Sylmar, California, following an inspection of the facility. Regulators followed up with an official “warning letter” in January 2013.
St. Jude makes cardiac rhythm management products, which include pacemakers, defibrillators, and leads—wires that connect defibrillators to the heart—at the plant, and St. Jude’s Durata brand leads, which have been the subject of some controversy, were at the center of the FDA inspection.
St. Jude vowed to address the FDA's concerns, saying in a letter that it would make a variety of improvements. For example, the company 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 appears the company's efforts have paid off: St. Jude said Wednesday that it received notification from the FDA that the issues cited in the warning letter have been appropriately addressed.
“We take our responsibility as a medical device manufacturer very seriously,” Chairman, President and CEO Dan Starks said in a statement. “We are encouraged by the resolution of the FDA’s warning letter and will continue to work to ensure the highest standards are met across our manufacturing facilities. St. Jude Medical is committed to providing our patients, customers, and regulators with products and services that meet or exceed their expectations of safety, high-quality performance, reliability, and service.”
St. Jude is one of Minnesota's 15 largest public companies based on its revenue, which totaled $5.5 billion in its most recent fiscal year.
The company's defibrillator leads have come under scrutiny in recent years. St. Jude stopped selling its Riata leads in late 2010, and it subsequently launched its Durata line, claiming that the new leads were designed to prevent the problems seen in the older ones.
In its warning letter, the FDA had complained that St. Jude, at its California facility, had failed to adhere to policies regarding the testing of its Durata product, among other things.