FDA warns St. Jude Medical on California plant
As predicted by CEO Daniel Starks, the FDA warns St. Jude Medical about a series of violations found at a California plant that makes cardiac medical device.
The FDA warned St. Jude Medical (NYSE:STJ) about procedural violation at a plant in Sylmar, California, but the medical device company said the warning won't impede the manufacture of cardiac rhythm management products at the plant.
CEO Daniel Starks cautioned last week, when the company announced its 3rd-quarter results, that a so-called Form 483 could be forthcoming from the federal watchdog agency.
"It's a risk, and don't be shocked if that risk is realized," Starks said.