US FDA has made much progress over the past year in reducing the inventory of firms it has never inspected even though they market drug products or ingredients in the US, Alonza Cruse, who directs the Office of Pharmaceutical Quality Operations in the agency’s Office of Regulatory Affairs, told a June 4 meeting of the International Society for Pharmaceutical Engineering in Arlington, Virginia.
Not surprisingly, FDA is finding that these never-before-inspected facilities are more likely to have serious drug GMP issues than those...
