FDA is showing its enforcement muscle overseas with an increasing number of drug GMP warning letters going to facilities abroad. Of the 18 drug GMP letters issued in the second part of calendar year 2011, 10 went to foreign drug and API manufacturers.
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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