A Boehringer Ingelheim Corporation Shake Up and an FDA Warning Letter Over Production Gaffes

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After a string of grave and embarrassing manufacturing problems, Boehringer Ingelheim is overhauling some of its management. Late last week, Boehringer Ingelheim quietly posted on its web site that Wolfram Carius (see photo), a member of the board of managing directors who oversaw biopharmaceuticals and production, will be leaving the drugmaker next month after a 26-year career. And he will be replaced by Wolfgang Baiker, who most recently headed worldwide development (see this). His resignation occurs shortly after Boehringer received a searing warning letter from the FDA about serious production violations at a plant in Rhein, Germany, where agency inspectors last November found problems with active pharmaceutical ingredients and finished drug products, such as the big-selling Spiriva Handihaler, as well as a subsequent failure to take corrective actions.

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