Federal regulators sent Boston Scientific Corp. a warning letter identifying "serious regulatory problems" in medical devices produced at three facilities and said the company's previous efforts to address quality control problems at three other sites were inadequate.
The Food and Drug Administration's letter said it could take regulatory action against Boston Scientific without further notice and warned that "it is necessary to take action on this matter now."
The letter was sent to Boston Scientific on Wednesday. That was the same day Guidant Corp. accepted a $27 billion buyout bid from Boston Scientific, ending the Massachusetts company's nearly two month bidding war for Guidant with Johnson & Johnson.
Boston Scientific and the FDA separately disclosed the warning letter Thursday, after markets closed for the day.
The FDA's letter notified Boston Scientific that inspections conducted late last summer "revealed serious regulatory problems involving your medical devices."
The problems involved heart stents — metal-mesh devices used in artery-clearing surgery — made at the company's Natick headquarters and at facilities in Maple Grove, Minn., and Spencer, Ind.
The FDA also cited continuing problems at sites where it had previously found shortcomings. These are in Watertown, Mass.; Glens Falls, N.Y., and Quincy, Mass.
The letter does not prevent Boston Scientific from continuing to distribute its top-selling product, the Taxus drug-coated stent.
Jim Tobin, Boston Scientific's president and chief executive, said in a news release, "we have clearly not done enough to resolve the issues raised by the FDA last year." But he said the company was on track to resolve outstanding issues promptly.
In the summer of 2004, Boston Scientific recalled nearly 100,000 units of the Taxus stent and another model not coated with drugs because of a manufacturing defect that the company has said it has fixed.