Cordis Cardiology, a division of Cordis Corporation, a Johnson & Johnson Company, has received a warning letter from the US Food and Drug Administration (FDA) regarding FDA's observations concerning the Good Manufacturing Practice (GMP) regulations.
These observations followed standard post-approval site inspections completed in 2003, including sites involved in the production of the Cypher sirolimus-eluting coronary stent. Cordis has been engaged in improving manufacturing processes since launch of this product, an official release stated.
"We take the FDA observations very seriously, and we have been working aggressively to address and resolve the issues identified as quickly as possible," said Rick Anderson, president of the Cardiology Division.
"All products released to the market for use in patients are safe and meet product specifications approved by the FDA," added Anderson. Cordis will continue to supply products to the marketplace without interruption.
The Cypher Stent has benefited more than 600,000 patients worldwide since its European market introduction in April 2002, including more than 450,000 patients in the US since receiving FDA approval in April 2003.