UPDATED Oct. 6 with comment from St. Jude Medical.
St. Jude Medical (NYSE:STJ) last week revealed that the FDA sent it a warning letter after inspections at the Atlanta plant where it makes its CardioMEMS implantable heart monitor turned up problems with its corrective and preventive action plans.
Little Canada, Minn.-based St. Jude said Oct. 2 that the letter, dated Sept. 30, stemmed from inspections at the Atlanta site during June. The federal safety agency issued a Form 483 following the inspections, detailing problems with the way St. Jude documented its CAPA plans.
St. Jude “has not adequately investigated known problems identified through customer complaints, non-conformances, and other sources,” according to the letter, which St. Jude included in a regulatory filing.
The inspections also found problems with St. Jude’s process validation activities and the way it makes sure the CardioMEMS devices are in conformance with specifications, according to the letter.
St. Jude said the problems flagged in the letter don’t involve concerns over the performance of the CardioMEMS device or require a field action or recall.
“The company will continue manufacturing and shipping product from the Atlanta facility, and customer orders are not expected to be impacted while we work to resolve the FDA’s concerns,” according to the filing. “The company takes these matters seriously, will respond timely and fully to the FDA’s requests, and believes that the FDA’s concerns can be resolved without a material impact on the company’s financial results.”
A spokeswoman for St. Jude told MassDevice.com via email Oct. 6 that the FDA inspections last June came as the company was integrating the CardioMEMS operation, which it acquired in June 2014, into its global quality system. The company has since addressed most of the issues to the FDA’s satisfaction, she wrote.
“We are 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,” she wrote.