FDAnews
www.fdanews.com/articles/152828-generic-injectable-facility-warned-for-poor-cgmp-training

Generic Injectable Facility Warned for Poor cGMP Training

February 1, 2013
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. The contract manufacturer was warned last month after a series of responses to a June 2012 Form 483 proposing its corrective path forward failed to satisfy the FDA, according to the letter.
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