High Risk Drug Domestic and Foreign Drug Inspections – Get Ready

BOB POLLOCK | June 7, 2017

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After slogging through some of the FDA dashboards, I came across one that I felt was worthy of mention. The FDA’s Office of Regulatory Affairs (ORA) has apparently begun the process of scoring drug manufacturing establishments in their risk-based inspection program. The FDA has been talking about risk-based inspection (as well as risk-based review) ever since I was at the Agency, back when dinosaurs roamed the earth! The Agency states on the ORA dashboard (here) “FDA is continuing to develop a more quantitative risk model to help predict where FDA’s inspections are most likely to achieve the greatest public health impact. The Risk-Based Site Selection Model provides a risk score for each facility, which is a function of four component risk factors Product, Process, Facility, and Knowledge.” While there is no further explanation, nor a narrative of how the scoring is applied, there are metrics for the first quarter of FY 2017 and targets for high risk inspections listed for each of the four quarters.

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