The Food and Drug Administration warned Johnson & Johnson's Cordis Corp. of numerous violations of prescribed good manufacturing practices at the company's plants for the Cypher drug-eluting stent. Inspections last year at plants in Miami Lakes, Fla., Warren, N.J., Puerto Rico and Europe "found systemic violations in the quality management system employed to ensure the safety and effectiveness" of the stents, the FDA said in a warning letter dated April 1. The agency warned Cordis that there could be regulatory action without further notice. Cordis said it has been improving manufacturing processes since the Cypher's launch a year ago and management "is committed to addressing all issues" raised by the FDA. The company said that although management takes the FDA letter "very seriously," all stents that have been sold are safe and meet FDA product specifications.
Meanwhile, Boston Scientific said sales of its newly approved, drug-eluting Taxus stent -- the only competitor to Cordis' Cypher -- had exceeded rosy expectations. From when the FDA granted U.S. marketing approval March 8 to March 31, the company shipped approximately 133,000 stents in the U.S. and rang up U.S. net sales of $98 million, far exceeding a company forecast of between $54 million and $75 million for all of March. Worldwide net sales for the first quarter ended March 31 were $215 million, topping the company's expectation of $150 million to $180 million in worldwide net sales. -- by Cinda Becker