BioAsia 2015: FDA Bioresearch 483s In India Drop
This article was originally published in PharmAsia News
Executive Summary
US FDA inspections in India under the agency's Bioresearch Monitoring Program (BIMO) saw a peak of more than three dozen ‘483s’ being issued in fiscal 2010, though the actual numbers have declined in subsequent years – a trend that could potentially temper the debate on compliance concerns in the country.