Johnson & Johnson's woes just won't end. The company's Cordis unit has received a warning letter dated Feb. 16 for problems at a stent plant in Puerto Rico resulting from an inspection that took place last September and October. Among the problems mentioned in the letter was that process control procedures failed to ensure that a device conforms to certain required specifications.
"The specific violations noted in this letter and in the FDA 483 issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems," the letter states. "You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring your products into compliance."
A company spokeswoman said Cordis is working to address the issues raised by the FDA. "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," Sandra Pound explains in an emailed statement to the Wall Street Journal.
As the WSJ points out, Cordis is experiencing dwindling sales as it struggles with competition from newer stents from Abbott and Boston Scientific. In addition, the company's Nevo stent has been delayed as the company modifies a problem balloon catheter.