FDA to Double Foreign GMP Inspections This Year

The FDA intends to double its overseas inspections of facilities for good manufacturing practice (GMP) compliance this year from 50 to 100, according to the agency. The FDA is trying to beef up overseas GMP inspections, as opposed to inspections linked to an application, Edwin Rivera-Martinez, chief of the international compliance branch in CDER’s division of manufacturing and compliance, said Wednesday at the 14th Annual GMP by the Sea conference in Cambridge, Md. Overseas offices also may conduct unannounced inspections, he said. The agency plans to staff its Mexico City office by Nov. 1 with medicine and food experts, the next step in the FDA Without Borders initiative, he said.
Drug Industry Daily