"Corrupt" Lab Practices Pushes CRO Firm Cetero Research Into Bankruptcy
3/26/2012 7:50:14 AM
Contract research firm Cetero filed for bankruptcy protection early on Monday, court documents show, months after the U.S. drug regulator put the company on notice for faking documents and manipulating drug samples. In July last year, the U.S. Food and Drug Administration (FDA) said two 2010 inspections, an internal company investigation and a third-party audit uncovered "significant instances of misconduct and violations" at a Cetero facility in Houston. The Cary, North Carolina-based firm does early-phase clinical research and bioanalytics for a number of drugmakers. The pharmaceutical companies can then use those studies as supporting evidence in drug approval applications to the FDA.