Two inspections by the US Food and Drug Administration, an internal company investigation, and an inspection by a third party found instances of misconduct and other violations at a Cetero Research facility in Houston, reports Reuters. "The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five-year time frame," FDA said. According to a letter from FDA to Cetero, that misconduct included falsified lab records and sample manipulation. The agency also warned that drugmakers that used Cetero's services might have to re-do studies that the company did between April 2005 and June 2010. In its response, Cetero says that it "remains fully committed to maintaining the quality and integrity of the data collected in each of its facilities," adding that "the processes being used today at Cetero are state‐of‐the‐art" and "are in full compliance with FDA regulations and bioanalytical industry standards."
"Here's every outsourcing manager's nightmare: you contract out for research, and your CRO turns around the studies you want right on schedule," blogs Derek Lowe at In the Pipeline. "They send back the complete data package, and everything's in place. But they faked it."