Jim Tobin Resolve Quotations

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.

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.

The message was that we were not moving fast or deeply enough to resolve the problem ? they wondered if we got it. We have to get our act together and step it up and show them we do get it.