Boston Scientific, Natick, Mass., received a warning letter from the Food and Drug Administration saying that the company hadn't done enough to address quality-control violations identified in two 2005 inspections. The agency said it could take regulatory action and wouldn't grant marketing approval to new Boston Scientific devices until the issues are resolved. The inspections covered several devices, including Boston Scientific's drug-eluting stent. Boston Scientific said it will meet with the FDA next week. The agency hasn't barred the company from distributing products nor advised hospitals to stop using its products, Boston Scientific said. Read the letter.
Separately, Guidant Corp., Indianapolis, which just accepted a $27 billion buyout offer from Boston Scientific, announced that its fourth-quarter earnings were down 25%, to $78.9 million, because of product recalls last summer. For the year, Guidant said its net income fell 21% to $413.9 million and revenue dropped about 6% to $3.55 billion.