The real, I mean real issue is when is the FDA going to re-inspect the Hayward facility? Talent was added to solve all issues!
Impax is ready to walk the inspector by the hand and show them the improvements and documentation. Some guy was blathering about a 2010 inspection that was remedied by Watson Talent brought on board to fix all issues. In speaking with the Watson Talent the qauty people in place did not document properly in 2011 the remedied work for the 2010 initial findings.
I have spoke with members of the FDA and they told me the inspections are random and not planned. Due to the importance of Parkinson sufferers you would think that they would schedule a re-inspection immediately to bring a potential relief to those that suffer. Secondly Impax should spend and invest in updated state of the art equipment to insure there is never again an issue. They have the talent in place from Watson to place them in the forefront of the best manufactuing equipment and practices.
Time for some heads to role, Carol Maimon?? anyone?