FDA Sending More Drug GMP Warning Letters to Foreign Sites
This article was originally published in The Gold Sheet
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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FDA Commissioner Margaret Hamburg said that improving drug product quality will be one of the agency’s highest priorities this year and advised industry to do the same as the agency spearheads a number of new initiatives in this area. Yet is FDA taking a similarly aggressive approach to enforcement, given that the number of drug GMP warning letter declined 23%?
Eisai and Biogen Idec formed a manufacturing alliance for oral solids and parenteral capabilities, as Eisai continues to tinker with its global manufacturing model. Eisai also takes a new approach to academic partnerships with University College London for neurological targets.
FDA’s aggressive enforcement against pharmaceutical manufacturers for GMP violations continued in the first half of the year through its use of warning letters. Inadequate contamination controls was a common deficiency found in eight of the 18 drug GMP warning letters, failure to investigate out-of-specification results continues to be the most frequent GMP deficiency in warning letters, and cites of stability problems are increasing.