Valeant Pharmaceuticals has been on an acquisition spree, but perhaps the Canadian drugmaker may want to conduct a bit more due diligence before its next purchase. One of its recent deals was for Sanitas, which is based in Lithuania and controls Jelfa, another drugmaker based in Poland and that actually produces much of the Sanitas portfolio (read this). Valeant is paying about $455 million in cash (see here and here). However, a July 14 warning letter issued by the FDA to Jelfa notes that the Polish drugmaker has some basic problems with quality control. During an October 2010 inspection, the FDA found Jelfa did not thoroughly investigate the failure of a batch or any of its components to meet specifications, which the agency called an unacceptable practice. The FDA then offered a tutorial after Jelfa failed to investigate its manufacturing process and facility controls to identify the cause of a sterility failure.
