FDA Sends St. Jude Medical a Warning Letter Over CardioMEMS

Arundhati Parmar

FDA has sent St. Jude Medical a warning letter regarding its manufacturing plant in Atlanta which makes the CardioMEMS device, the Minnesota company disclosed Friday.

The agency faults the company for not following good manufacturing practices following an inspection made in June. FDA outlines those concerns in Form 483 and although St. Jude Medical addressed those concerns, they were not enough to prevent the warning letter from the agency.

The warning letter however doesn't prevent the medical device company to continue to manufacture and sell the CardioMEMS heart failure system, which is an implantable sensor that monitors pressure on the pulmonary artery considered to be the most accurate measure of whether a congestive heart failure patient's condition is worsening.

Specifically the warning letter said that the company did not maintain a proper Corrective Action and Preventive Action system, "and has not adequately investigated known problems identified through customer complaints...."

Other violations include inadequate documentation of process validation activities and a lack of well-developed, controlled and monitored production process.

The agency asked the company to submit documents that show that once it has completed actions to resolve the violations. The letter also acknowledges that other elements of the 483 communication from the FDA were adequately resolved.

"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 standalone facility into St. Jude Medical’s quality systems," St. Jude Medical's regulatory filing with the Securities & Exchange notes.

St. Jude Medical acquired CardioMEMS in May of last year. In September 2010, the medtech company purchased a 19% stake for $60 million in Atlanta-based CardioMEMS with an exclusive option to acquire it for an additional $375 million. 

Arundhati Parmar is senior editor at MD+DI. Reach her at [email protected] and on Twitter @aparmarbb