The FDA has warned Cordis, a unit of Johnson & Johnson, by letter about a failure to ensure that heart devices made at its Puerto Rico plant – such as stents used to prop open arteries – were manufactured with consistency. Specifically, the agency’s inspectors found that Cordis’ procedures did not prevent abnormal products or ensure that its devices met certain specifications.
The FDA uncovered the problems when it inspected the plant in September and October of 2010. Although the company has since said it would take steps to address the issues, agency officials said in the letter that those steps either did not work or did not go far enough. The FDA can seek penalties such as injunctions or fines. J&J’s reputation has been badly tarnished by manufacturing and quality control problems at its plants that have led to a series of recalls of widely-used consumer healthcare medicines. Such products as Tylenol, Rolaids and Motrin, medical devices and other products, including syringes and sutures have been recalled.
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.