- The Washington Times - Tuesday, December 27, 2005

Defibrillator manufacturer Guidant Corp. yesterday said it received a warning letter from federal regulators on unresolved quality problems for its St. Paul, Minn., plant.

The Indianapolis company recalled 109,000 of its devices in June because of failures that linked them with at least seven deaths.

Guidant said it received the letter Friday from the Food and Drug Administration (FDA). The letter, which outlined at least eight quality-control failures, followed a Sept. 1 inspection of the plant, at which implantable pacemakers and defibrillators are made.

The violations “may be symptomatic of serious underlying problems in your firm’s manufacturing and quality-assurance systems,” said the FDA, which regulates the sale of prescription drugs and medical devices.

Guidant yesterday said the company “has provided the FDA with monthly updates on its progress and has thus far completed 90 percent of the commitments that it made in its initial response.”

The letter halted export certificates and market approval for new devices coming out of the plant, but Guidant said it “believes that it can fully address the concerns of the FDA without a material impact to its business.”

Shares of Guidant slid $2.29, or 3 percent, to close at $64.69 yesterday on the New York Stock Exchange.

The warning letter comes as medical-device giants Johnson & Johnson and Boston Scientific Corp. are engaged in a bidding war over Guidant.

Boston Scientific earlier this month made a $25 billion bid for Guidant, topping Johnson & Johnson’s $21.5 billion offer.

“We continue to move forward on our due diligence with the goal of reaching a definitive agreement with Guidant,” said Boston Scientific spokesman Paul Donovan.

A spokesman from Johnson & Johnson declined to comment.

The FDA made 15 recommendations to improve Guidant’s facility in the initial inspection in September, said Guidant spokeswoman Annette Ruzicka.

Ms. Ruzicka, who said she had not seen the FDA letter, declined to say what actions Guidant would need to take to comply with the agency’s demands.

FDA spokesman Michael Herndon said Guidant already had taken steps to correct the quality issues, which did not shut down operations at the Minnesota plant.

LOAD COMMENTS ()

 

Click to Read More

Click to Hide