St. Jude Medical received a warning letter dated April 17 from the FDA related to its atrial fibrillation (AF) division manufacturing facility in Minnetonka, Minn., which makes Safire ablation catheters.
A Securities and Exchange Commission (SEC) filing on Tuesday revealed that the FDA inspected St. Jude's catheter manufacturing facility in Minnetonka at various times between Dec. 8 and Dec. 19, 2008. On Dec. 19, 2008, the FDA issued a Form 483 identifying certain observed non-conformity with current good manufacturing practice (cGMP) primarily related to the manufacture and assembly of the Safire ablation catheter with a 4- or 5-mm non-irrigated tip.
For 2008, the Safire ablation catheters accounted for approximately $6 million in worldwide sales.
St. Jude said its AF division provided written responses to the FDA detailing proposed corrective actions, noting it initiated efforts to address the agency's observations of non-conformity. The FDA warning letter acknowledges actions already taken by St. Jude's AF division to address the observations, according to the company.
The FDA letter notes that it will not grant requests for exportation certificates to foreign governments or approve pre-market approval applications for Class III devices to which the quality system regulation deviations are reasonably related until the violations have been corrected.
The company said it takes "these matters seriously and has already begun to respond timely and fully to the FDA's requests, and believes that the FDA's concerns can be resolved without a material impact on the company's financial results."
In fact, Dan Starks, CEO of St. Jude, said that the warning letter is "embarrassing," but would not affect the rollout of any new products.