Medtronic has reached a consent decree with the FDA that all but bars the company from selling its SynchroMed II drug infusion system.
The decree follows repeated flouting of FDA quality system regulations, including rules governing design controls and corrective and preventive actions. Medtronic’s Columbia Heights, Minn., plant, where SynchroMed is made, has received three warning letters on similar violations since 2006. The problems could lead to over- or under-infusion or a delay in therapy for patients, the FDA says.
Medtronic met with the FDA to discuss concerns in January 2013 and said it was taking steps to address the violations. However, an April 2013 inspection found continued problems. The devicemaker’s response to that inspection did not convince the FDA that the violations had been corrected.
Under the terms of the consent decree, Medtronic cannot manufacture or distribute SynchroMed II implantable Infusion Pump System units unless a physician deems the pump medically necessary. The company must also hire a third-party expert to help it develop plans to correct the various issues.
A pump remediation plan to correct the violations is due to the FDA within 20 days, and the consent decree will remain in effect until all violations are corrected, the agency says.
The remediation plan needs to include the following information:
Medtronic says it will focus corrective efforts on implementing SynchroMed pump design changes and enhancing the business unit’s quality systems. The company is working with the FDA to address the violations as quickly as possible.