FDA warns St. Jude over inadequate testing of medical device parts

St. Jude Medical has received a warning letter from the U.S. Food and Drug Administration concerning shortcomings found in the testing of medical device components at a California plant.

The facility develops wires that connect an implantable defibrillator to a patient's heart.

The company had said a warning could be coming, said Morningstar medical device analyst Debbie Wang.

"We don't think this FDA warning letter is a big deal for St. Jude because the firm does not currently have any major products from the Sylmar facility awaiting regulatory approval," Wang said. "Tight now everything is going on as usual."

Copies of the letter were not available. St. Jude said the letter does not reflect safety concerns about any product. However, failure to address the problems the FDA cited could impair some company exports and the approval of new devices. The firm said it will work with the FDA to resolve testing and staff training issues. Meanwhile, customer orders are expected to be unaffected.

Warning letters typically indicate FDA displeasure with a company's response or a decision the matter involved is significant enough to warrant a formal warning for the record, said industry consultant David Furr. The FDA issued about 700 warning letters last year.

"If they felt you either didn't understand or adequately respond to the observations, they can certainly issue a warning letter," Furr said. "They also issue warning letters if you didn't respond in a timely fashion."