A warning letter sent to medical device manufacturer St. Jude Medical on 10 January 2013 by the US Food and Drug Administration (FDA) says that inspectors found numerous violations related to the manufacture of two of its implantable cardiac defibrillator (ICD) leads at the company's Sylmar, CA manufacturing facility.
The letter references a nearly month-long inspection starting in late September 2012 in which FDA assessed the company's compliance with federal quality system regulations in regards to the manufacture of two of its products: the Durata and Riata ST Optim high-voltage ICD leads.
FDA issued an FDA Form 483-a notice of violations-to the company on 17 October, and the two parties went through two rounds of correspondence before FDA indicated that some of the firm's responses were inadequate to alleviate its concerns and issued its warning letter.
For example, the letter indicates that the design of the device was improperly verified. "Your firm failed to validate the [redacted] test methods implemented during the Durata design verification testing," FDA wrote. "These test methods were created in-house to verify your firm's design inputs; however, they were not based on and did not follow a national standard."
In other instances, St. Jude reportedly failed to follow its own standards. FDA said that its inspection showed that the company's design verification process called for Durata leads to be tested five times each prior to release, with the mean of the tests making up the final score. "However, your firm only tested each lead one time to determine the results," FDA said.
In another case, the company put the cart before the horse, so to speak. The company performed design verification testing in June 2007 on the Durata device, according to its records. That testing occurred a month before establishing design inputs establishing what the outputs of testing would need to be, FDA said, noting that St. Jude said it would be conducting a "systematic review of completion dates and key phases in design history to identify and remediate any gaps."
Neither device had fully completed the required design history file, FDA found, including the dates when key elements of the design and development process were conducted and approved.
Perhaps more importantly, however, FDA inspectors determined that the company's Durata lead product is "misbranded … in that [St. Jude] failed or refused to furnish material" to FDA. That material, FDA explained, included adverse event reports that should have been reported to the agency in a timely manner since the device is life-supporting and sustaining.
"For example, [four complaints] refer to malfunctions of your firm's Durata lead," FDA wrote. "The Durata lead is a life-supporting or life-sustaining medical device and a malfunction involving such a device is reportable. There is no information in your firm's complaint file that justifies why the malfunctions referenced above would not be likely to cause or contribute to a reportable death or serious injury were they to recur. An MDR should have been submitted for each of the referenced complaints."
The warning letter went on to explain that the violations "may be symptomatic of serious problems in [St. Jude's] manufacturing and quality management systems," and that regulators will not approve any of the company's applications for a Class III device for which the noted violations could be "reasonably related" until they are fixed.
In its 8k financial regulatory filing earlier this week, St. Jude said that it is "giving the highest priority to fully remediating these concerns," and highlighted that FDA had not identified "any specific concerns regarding the performance of, or indicated the need for any field or other action regarding, the Riata ST Optim or Durata leads or any other St. Jude Medical product."
The company's Sylmar facility will not be impacted by the letter and will continue to manufacture and ship products, St. Jude added.