St. Jude Medical, a healthcare products company based in St. Paul, Minnesota, received a warning letter from the United States Food and Drug Administration over issues at its plant in Sylmar, California. The plant manufactures the company’s next-gen Durata defibrillator leads.
According to information from an SEC regulatory filing, the company decided to ignore the FDA’s Form 483 warning letter. The letter detailed 11 quality control and documentation issues at the plant. However, the company stated that the warning letter was expected. In its October 3rd-quarter earnings conference call, management discussed that the official warning was imminent.
While the letter from the FDA states that it will not grant the company requests for export certificates or PMA for Class III devices, it did not “identify any specific concerns regarding the performance of, or indicate the need for any field or other action regarding, the Riata ST Optim or Durata leads or any other St. Jude Medical product.” The SEC filing continued, "Accordingly, the Company will continue manufacturing and shipping product from the Sylmar facility and customer orders are not expected to be impacted while we work to resolve the FDA's concerns."
At the J.P Morgan Healthcare Conference, Daniel Starks, CEO of St. Jude Medical, spent a significant amount of time allaying investor fears over issues at the Sylmar plant. However, the recent Riata lead recall, FDA warnings and issues at the Sylmar plant have lead to a challenging business environment for the company.