FDA clears St. Jude Medical
pharmafile | July 4, 2014 | News story | Manufacturing and Production, Sales and Marketing | CardioMEMS, FDA, california, st jude medical
US medical device manufacturer St. Jude Medical has been given a clean bill of health by the Food and Drug Administration over problems at one of its facilities.
The FDA had raised its concerns in January 2013 regarding the Sylmar, California plant but now believes that all the issues have been resolved.
“It appears that you have addressed the violations contained in this warning letter,” the FDA wrote in another letter this week. “Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.”
The regulator had slammed the company for inadequate monitoring and control of manufacturing processes, in relation to its Durata and Riata ST Optim high voltage implantable cardiac leads.
One problem was that the firm created multiple different holders to hold the leads during their manufacture but “did not specify how these holders were installed or qualified to ensure they met their intended use”.
“Your firm has not provided a description or evidence of consideration of a systemic corrective action,” the warning letter went on.
There were several other issues: for example, St. Jude had said it would prioritise and conduct the test method validations for the Durata lead and other product lines – but the FDA countered that it had not produced evidence to back this up.
The FDA was also concerned that the company could not demonstrate when key elements of a design history file for the Durata design project were conducted and approved, such as design inputs, outputs, verification, validation, and design transfer.
The Durata lead was also misbranded, the regulator said.
While all this now seems to have been sorted out, the FDA added: “This letter does not relieve the firm from the responsibility of taking all necessary steps to assure sustained compliance” and warned of possible future regulatory action “should violations be observed during a subsequent inspection or through other means”.
“We take our responsibility as a medical device manufacturer very seriously,” says Dan Starks, St. Jude chief executive. “We are encouraged by the resolution of the FDA’s warning letter and will continue to work to ensure the highest standards are met across our manufacturing facilities.”
Last month the company bought the privately-held firm CardioMEMS, maker of the CardioMEMS HF System, which is the first FDA-approved heart failure monitoring device proven to significantly reduce hospital admissions.
“St. Jude Medical is committed to providing our patients, customers and regulators with products and services that meet or exceed their expectations of safety, high-quality performance, reliability and service,” Starks concludes.
Adam Hill
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