Jim Tobin Fda Quotations

Product quality and performance have always been a top priority at Boston Scientific. We are bringing the same urgency to our overall quality and reporting management. We believe we have made a lot of progress, but we still have a ways to go. We are looking forward to our meeting with the FDA and to resolving these issues.

Although we are pleased with the result of the inspection of our largest plant, we have clearly not done enough to resolve the issues raised by the FDA last year. We are confident we have addressed many of these issues, but others have not yet been fully resolved. We will work closely with the FDA to resolve these outstanding issues, and we believe we are on track to do so promptly.

We have clearly not done enough to resolve the issues raised by the FDA last year. We believe we have made a lot of progress, but we still have a ways to go. We are looking forward to our meeting with the FDA and to resolving these issues.