The FDA took the first step towards a potential warning letter for St. Jude Medical (NYSE:STJ) about procedural violation at a plant in Sylmar, California, but the medical device company said the action 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.
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Inspections between Sept. 25 and Oct. 17 turned up 11 "observations" of problems from an FDA investigator, according to the heavily redacted Form 483 St. Jude posted in a regulatory filing.
St. Jude said it plans to respond to the FDA by Nov. 7 "detailing proposed corrective actions, and has initiated efforts and redirected resources to address the FDA’s observations," according to the filing.
"It is important to note that none of the observations identified a specific issue regarding the clinical or field performance of any particular device. The Sylmar, Calif., facility will continue to manufacture cardiac rhythm management devices while the company works with the FDA to address these observations," STJ said. "The company takes quality and product safety very seriously and is committed to fully resolving the quality system observations identified during this most recent FDA inspection."
The cost of fixing an problems isn’t expected to materially affect St. Jude financially, it said.
News of the potential warning, plus a lowered outlook for the rest of the year, shaved about 3% from St. Jude’s share price last week. The stock’s value recovered a bit today, however, on news of positive results from a clinical trial of its PressureWire fractional flow reserve technology.
