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Drug GMP Warning Letters, Enforcement Could Rebound in Obama's FDA

This article was originally published in The Gold Sheet

Executive Summary

Reversal of downward enforcement trend expected after President Obama's team takes reins at FDA. After eight years of declining inspection activity, field staffing and warning letter issuance, industry is bracing for change. Obama demands "full review" of FDA over peanut recall. More criminal prosecutions expected. Congress plies agency with money for overseas inspections. FDA headquarters could unleash warning letters. New investigators will learn domestically while seasoned ones retire or head overseas. Focus of warning letters begins shifting abroad. Form 483 reports and warning letters continue to raise the same key issues. Production record review, data integrity, process validation concerns highlighted. Issues raised in 18 FY 2008 drug GMP warning letters detailed in chart beginning on page 12.

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