St. Jude Medical admits to quality control problems at the plant that makes its Durata defibrillator leads in a letter to the FDA reviewed by the Wall Street Journal and says it's putting procedures in place to remedy the issues.
St. Jude Medical (NYSE:STJ) copped to quality control problems at the Sylmar, Calif., plant that makes its next-generation Durata defibrillator leads, saying it's put measures in place to remedy the issues.
STJ shares plunged late last year after it said the federal watchdog agency might issue a warning letter to the St. Paul, Minn.-based medical device company. Share prices have since recovered, but investors are holding their breath until the possibility of a formal warning letter passes.
St. Jude stock ticked up 0.3% today as of about 1:50 p.m., to $37.29 each.
In a Nov. 7 letter to the FDA reviewed by the Wall Street Journal, St. Jude admitted to the issues flagged by the FDA after inspections of the Sylmar plant, saying it plans to improve training and quality-control procedures and promising specific steps to remedy the problems, according to the newspaper.
The FDA labels as Class I CareFusion's recall of its Avea ventilators over a possibly fatal...
Small medtech companies are finding value in outsourcing their research & development functions,...
VertiFlex says it won pre-market approval from the FDA for its Superion interspinous spacer.
China is investigating a former top healthcare official on suspicion of bribery.
Medtronic is reportedly looking to grow its presence in China with lower-cost devices, as well as...