As many on this board are aware, Impax Labs received provisional FDA approval last year to produce Rytary, an extended release carbidopa-levodopa. However, they were never given final approval due to numerous and serious problems and violations at their Hayward manufacturing facility. They made several attempts at solving the problems but have continuously failed. It got so bad that GSK walked away from a international distribution contract costing Impax $175 million.

Impax released their 3rd quarter earnings today. On the conference call, they stated they met with the FDA last week to discuss the quality and manufacturing changes they plan to implement. However, they were not given approval to begin manufacturing at the plant. The FDA will first have to fully re-inspect the facility. No date for re-inspection was given.

This sort of ties in with the previous thread on the manufacturing issues with herbal supplements. I wouldn't want to be the first PWP to begin taking Rytary, even after a FDA inspection.