Sanctions Lifted on Cordis' Drug-Coated Heart Stents
June 15, 2007 — Johnson & Johnson says U.S. regulators have ended almost three years of sanctions over manufacturing quality that limited the company's ability to sell drug-coated heart stents.
The FDA notified Cordis Corp., a unit of Johnson & Johnson, that it had lifted a warning letter that had been issued in 2004. The letter dealt with quality assurance at seven manufacturing plants.
According to Cordis, the warning letter said the company failed to meet specifications for design, manufacturing, packing and storage of its Cypher stents, the drug-coated devices that are used to keep coronary arteries open.
The company continued to produce the stents, but the warning letter prevented Cordis from applying to the FDA for approval for new uses as well as new generations of the devices in the United States, company spokesman Christopher Allman said.
Cordis announced Thursday that it had received notice from the FDA that all items outlined in the warning letter had now been resolved.
The company says its stents have been used in about 3 million patients worldwide.
For more information: www.cordis.com