St. Jude Receives FDA Letter Citing Issues at CA Plant

The medical device giant said that the letter contained “11 observations” about its manufacturing plant in Sylmar, California; St. Jude vowed to respond to the FDA by November 7 and said it “has initiated efforts and redirected resources to address the FDA’s observations.”
St. Jude Receives FDA Letter Citing Issues at CA Plant

About a week after St. Jude Medical CEO Dan Starks warned that the company was likely to receive a warning letter from health regulators about a manufacturing plant in California, the company reported that it received a “Form 483” from the U.S. Food and Drug Administration (FDA).
Little Canada-based St. Jude revealed in a Wednesday regulatory filing that the form it received contained “11 observations” about its facility in Sylmar, California—which the FDA inspected in late September.
The medical device giant included the form, with numerous portions redacted, in its Wednesday filing with the U.S. Securities and Exchange Commission. The observations were related to “process validation,” “design verification,” inadequate training of both internal auditors and design controls, and canine testing processes, among other issues.
St. Jude said that it would respond to the FDA by November 7 and detail proposed corrective actions. Meanwhile, the company said that it “has initiated efforts and redirected resources to address the FDA’s observations.”
“It is important to note that none of the observations identified a specific issue regarding the clinical or field performance of any particular device,” St. Jude added.
At the Sylmar plant, St. Jude makes cardiac rhythm management products, which include pacemakers, defibrillators, and leads—wires that connect defibrillators to the heart. The company said Wednesday that it will continue to manufacture such products while working with the FDA to address its concerns.
St. Jude doesn’t expect the costs associated with resolving the issues will have a “material impact” on its financial results.
Last week, Starks said during St. Jude’s third-quarter earnings call that the Sylmar plant was undergoing a routine inspection by the FDA and the inspection would likely lead to a negative report. Starks said at the time that the company “would not be surprised” if the FDA’s observations resulted in a warning letter. He declined to reveal why he thought a warning letter was a possibility but said he wasn’t aware of any problems at the plant.
St. Jude is among Minnesota’s 15-largest public companies based on revenue, which totaled $5.6 billion in 2011. The company said last week that earnings for the third quarter that ended September 29 were down 22.5 percent compared to the same quarter last year. Meanwhile, net income totaled $176 million, or 56 cents per share, and net sales were $1.3 billion—down 4 percent from the same period last year. Sales from the company’s cardiac rhythm management products totaled $691 million, down 8 percent from a year earlier.