The FDA found what it described as several inadequacies during an inspection of a St. Jude Medical facility in California. In a redacted report, the agency cited activities related to St. Jude’s Durata product.
The report lists inspection findings from Sept. 25 through Oct. 17 at a facility in Sylmar, Calif. Among the items identified as inadequate:
- Process validation;
- Design verification;
- Design validation, including Durata risk analysis;
- Internal auditor and design training;
- Document control; and
- Control of inspection, measuring and equipment.
In addition, inspectors wrote that the corrective action “for your Riata lead was inadequate in that you failed to evaluate the validity of some of your Durata lead design verification and validation activities.”
St. Jude ceased selling Riata leads in late 2010 and recalled them in late 2011 after reports of premature erosion of the insulation around the electrical conductor wires. In August, the FDA required St. Jude to conduct three-year post-market surveillance studies on its Riata and Riata ST leads, as well as its QuickFlex LV CRT leads; QuickSite LV CRT leads; and Riata ST Optim and Durata implantable cardioverter-defibrillator (ICD) leads.
In its inspection report, the FDA said the process validation protocol for machinery was inadequate and noted that it did not evaluate differences in machines that had been installed over a 12-year span.
“Your design verification activities were inadequate in that you failed to validate three test methods you created in-house to verify your design inputs during your designed verification,” inspectors wrote. They continued that written test procedures called for a lead to be tested five times with the mean used as the test result. Instead each lead was tested once.
The Durata design risk assessment combined different recalled and nonrecalled devices, according to the FDA. Inspectors also found fault with internal auditor and design training, citing issues with the Durata design history file and “ambiguous input.”
The inspectors included annotations of promises to correct items listed in the redacted report. Contents of the inspection report do not represent a final determination by the FDA, nor are the items in the report necessarily an exhaustive list.
The redacted report is available here.