FDAnews Drug Daily Bulletin

German CMO Warned: Poor Training Led to Employee ‘Performance Lapses’

Jan. 22, 2013
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Improper staff training at Hameln Pharmaceuticals’ new state-of-the-art, sterile plant in Hameln, Germany, has given rise to employee “performance lapses,” a recently posted warning letter states. These lapses caused “significant violations” of good manufacturing practice regulations, it adds.
Washington Drug Letter