The local unit of German pharmaceutical firm Boehringer Ingelheim, Ben Venue Laboratories Inc., would be disallowed to manufacturer or distribute pharmaceutical products from its factory in Bedford, OH. This prohibition is effective until US regulatory authorities have determined the plant's compliance with existing standards of manufacturing in the United States.
The US Food and Drug Administration had sought court approval of a consent decree last Thursday to require the company to comply with current regulatory requisites or be fined and/or penalized should it fail to do so. In a statement, the US FDA said Ben Venue had repeatedly failed to meet good manufacturing standards. These include poorly maintained equipment whose current state sheds unwanted material into injectable drugs.
According to FDA Acting Associate Commissioner for Regulatory Affairs Melinda Plaisier, "The company's failure to promptly address these problems put patients at risk of receiving poor quality drugs and compromises the availability of medically necessary products."
Join the Conversation