FDA shifts how it prioritizes which pharma sites to inspect
When the FDA decides which pharma manufacturing sites it needs to inspect in any given year — outside of the inspections that occur just prior to the approval of a new drug or biologic — the agency has to weigh several different factors to prioritize sites for these routine, quality-related (i.e., current good manufacturing practice) surveillance inspections.
But thanks to the Food and Drug Omnibus Reform Act, or FDORA, which was attached to a recent spending bill that President Biden signed, the FDA now has updated its risk-based model by adding a risk factor about the compliance history of establishments in the country or region in which an establishment is located.
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