Since most APIs are manufactured outside the US (80 percent or so), and the FDA’s moving to the MRA for inspections, what training is being given to government inspectors outside the US, and what about FDA foreign inspection teams?

We intend to have the same training in Europe as we have outlined here. Nearly all of the
associations, including the European inspectors and the European Commission, who are
supporting or co-sponsoring this event, are participating. It will be a big move forward for
European inspectors and for some parts of the industry, in understanding how GMPs are applied
to this aspect of the industry.