FDA Warns St. Jude over CardioMEMS Manufacturing

Most of the problems FDA brought up over St. Jude Medical's Atlanta facility have been addressed, the company says.

Nancy Crotti

FDA has sent St. Jude Medical (SJM) a warning letter about the company's corrective and preventive action plans for the manufacture of the CardioMEMS implantable heart monitor.

The company referenced the September 30 letter in an SEC filing last week. FDA wrote it following June inspections at the Atlanta, GA, plant that manufactures the device. St. Jude Medical bought the company, its heart failure device, and the manufacturing plant in 2014.

FDA issued a Form 483 "identifying certain observed non-conformities with current good manufacturing practice," according to the SEC filing.

FDA's letter indicated the company had failed to adequately:

"At the time of the June 2015 CardioMEMS post-approval inspection, the company was transitioning the Atlanta facility into our global quality system," company spokesperson Justin Paquette wrote in an email to Qmed. "In response to the observations, we submitted our corrective actions to FDA in July and provided updates in August and September. The FDA has acknowledged that the company appears to have adequately addressed the majority of the FDA observations."

FDA approved CardioMEMS in 2014. The paper clip-sized wireless device uses pressure sensor technology, designed for jet engines, inside the pulmonary artery.

"We take these matters very seriously," Paquette wrote. "And we are working diligently to fully address everything that is outlined in the agency's letter."

St. Jude pointed out that the agency did not identify specific concerns regarding the performance of, or indicate the need for any field or other action regarding, CardioMEMS.

"We will continue manufacturing and shipping product from the Atlanta, GA, facility, and customer orders are not expected to be impacted while we work to resolve the FDA's concerns," Paquette concluded.

Nancy Crotti is a contributor to Qmed and MPMN.

Like what you're reading? Subscribe to our daily e-newsletter.