Cordis Resolves FDA Warning Letter

Heart device unit of Johnson & Johnson clears up FDA concerns on design, manufacturing, packaging and storage of drug-coated heart stents.

MIAMI LAKES, Fla. (AP) - Cordis Corp., the heart device unit of Johnson & Johnson, said Thursday the Food and Drug Administration notified the company it had satisfied concerns outlined in a warning letter.
FDA warning letters are issued to companies after the agency conducts inspections of their facilities and finds outstanding violations of good manufacturing practices.
In 2004, the FDA sent Cordis a warning letter saying the company failed to meet specifications for design, manufacturing, packing and storage of its Cypher drug-coated heart stents. Stents are tiny wire mesh tubes that act as scaffolding inside diseased arteries. The most popular types of the devices are coated with a drug to prevent tissue from growing back through the mesh.
Currently, the Cypher is the only competitor to Boston Scientific Corp.'s Taxus drug-coated stent in the U.S. market.
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