FDAnews
www.fdanews.com/articles/159305-fda-veteran-focus-on-raw-data-over-procedures-during-inspections

FDA Veteran: Focus on Raw Data Over Procedures During Inspections

November 1, 2013
FDA investigators increasingly are shifting from “top down” inspections focused on policies to “bottom up” inspections that focus on raw data, an industry insider says. Developing an effective game plan for handling inspections and knowing how to interpret certain “red flags” can mean the difference between a good inspection and one that goes south.
Devices & Diagnostics Letter