The bad news continues to mount for Johnson & Johnson’s (NYSE:JNJ) cardiac stent-making arm Cordis Corp., which received an FDA warning letter about a manufacturing facility in Puerto Rico.
In the Feb. 16 letter, FDA officials flagged Cordis for not following uniform design specifications in building its Cypher stent line, according to the Wall Street Journal, and said it won’t approve applications for related products until the violations are corrected. The letter was made public by Food & Drug Administration officials March 8.
Spokeswoman Sandra Pound told the Journal that, “based on the medical input we have received, we do not believe this issue impacts product safety and efficacy and we are confident our product remains safe and effective for use.”
Read more of our coverage on the medical device industry in Puerto Rico
The troubles are just the latest in a string of bad news for Cordis and Johnson & Johnson. The JNJ subsidiary said last month that it plans to lay off some of its sales force and merge two sales operations in response to sliding Cypher sales. The health conglomerate wouldn’t reveal how many workers will lose their jobs, but said the new sales operation will target decision-makers in hospitals’ purchasing departments as well as individual physicians.
The layoffs were JNJ’s latest response to declining stent sales. Cordis jockeys for market share with other device-making giants, including Abbott (NYSE:ABT), Medtronic Inc. (NYSE:MDT) and Boston Scientific Corp. (NYSE:BSX).
Cordis posted a 10 percent top-line slump during the fourth quarter, to $629 million from $697 million during the same period in 2009. Full-year sales were $2.5 billion, a 4.7 percent slide from $2.7 billion in 2009. Worldwide DES sales were $134 million, down 38 percent from $223 million during the 2009 fourth quarter and plunged 31 percent to $627 million during 2010. Company officials said the slumping DES sales were the result of “continued market and competitive pressures.”
