The FDA sent a warning letter to St. Jude Medical regarding a facility in Atlanta where the company manufactures its CardioMEMS heart failure system. St. Jude Medical revealed the information in an 8-K filing to the Securities and Exchange Commission on Oct. 1.
The FDA said St. Jude Medical did not conform with current good manufacturing practice at its Atlanta facility. The letter did not mention any other facility and did not identify concerns regarding the performance of the CardioMEMS system or any other St. Jude Medical product.
In May 2014, the FDA approved the CardioMEMS system, which is the first permanently implantable wireless system intended to measure pulmonary artery pressures in patients with heart failure. The FDA had rejected the device's approval application in 2011.
After St. Jude Medical received a form from the FDA on July 6, the company wrote to the agency and detailed its corrective actions. The FDA inspected the Atlanta facility from June 8 to June 26.
“Since the completion of the FDA inspection, the Company has provided and will continue to provide the FDA with regular monthly updates, and the FDA warning letter acknowledges the actions already taken by the Company to address the observations,” St. Jude Medical said. “The Company is in the process of working diligently to completely remediate the FDA’s observations for the Atlanta facility and fully integrate this former CardioMEMS stand-alone facility into St. Jude Medical’s quality systems.”