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FDA Continues Aggressive Enforcement as Drug GMP Warning Letters Mount

This article was originally published in The Gold Sheet

Executive Summary

The Obama administration’s FDA continues to deliver on its promise of swift and aggressive enforcement of drug GMP requirements that it pronounced two years ago.

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Foreign Drugmakers Now Getting More GMP Warning Letters Than U.S. Firms

For the first time, this fiscal year FDA seems to be on track to send more warning letters to foreign manufacturers of finished pharmaceuticals and APIs than their domestic counterparts.

Foreign Drugmakers Now Getting More GMP Warning Letters Than U.S. Firms

For the first time, this fiscal year FDA seems to be on track to send more warning letters to foreign manufacturers of finished pharmaceuticals and APIs than their domestic counterparts.

FDA Sending More Drug GMP Warning Letters to Foreign Sites

FDA warning letters are up at foreign sites and down at domestic sites as agency ramps up presence abroad. Inadequate OOS investigations and faulty testing of drug components were top violations; contamination was a common issue; firms cited included Novartis, Mylan, Smithkline Beecham, Lonza and Noven.

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