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

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.

During the inspection of the Hameln facility, investigators observed employees making inaccurate microbial counts and not following sterile filling operation procedures related to glove change frequency, the handling of dropped objects and sample acquisition.

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