Published October 17, 2012
St. Jude Medical Inc said on Wednesday there is a possibility that it will receive a warning letter from the U.S. Food and Drug Administration about its manufacturing facility in Sylmar, California, where it makes cardiac rhythm management products.
The company flagged the risk of the letter, known in the industry as Form 483, on its earnings call with analysts.
"It's a risk and don't be shocked if that risk is realized," Chief Executive Dan Starks told the conference call. (Reporting By Debra Sherman; Editing by Gerald E. McCormick)