Less redacted FDA report suggests Durata focus for St Jude 483s
Since Yahoo does not allow links, go to google and search for UCM328488. Click on the link from the FDA's website for the 483s. You'll see that it clearly refers to Durata in most of the observations.
St. Jude's redacted out Durata and said during the conference call, if I'm not mistaken, that the audit was not focused on a specific product. This suggests to me that either the FDA was focused on Durata or at least using Durata as their case-study for examining St. Jude's design control processes.
This combined with the potential loss of Optim supply from Aortech (which is used on all their leads I think) may put significant weight on CRDM sales. CRDM sales make up a significant portion of revenue.
Regardless, both of these issues are going to be a distraction to senior management and could divert resources from new product development.