FDAnews
www.fdanews.com/articles/148664-fda-issues-enforcement-action-based-on-non-fda-inspection

FDA Issues Enforcement Action Based on Non-FDA Inspection

August 13, 2012
International cooperation between regulators is “taking off” — a trend that could limit the amount of duplicate inspections drugmakers face, a top CDER official says. While “mutual recognition” of inspections is not yet a reality, drugmakers shouldn’t expect the FDA to close its eyes to negative inspection findings from other regulators.
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