A little more than a day after the FDA issued a scathing report on the CRO Cetero, claiming that employees at its Houston lab had routinely falsified trial data, the clinical research organization issued a release in its own defense, claiming that it had proactively contacted the FDA about a problem limited to a few lab workers who had been seeking added pay for overtime work.
According to Cetero, the company contacted the FDA after it conducted an internal investigation of its own and found that 6 chemists in the Houston lab "had misreported the date that samples were extracted prior to analysis. The chemists did this to seek additional compensation through weekend pay and pay for hours when they did not actually work."
In a release sent to FierceBiotech this morning, Cetero said that its commitment to quality and its action informing the FDA of the problem made the agency's statement "difficult to understand."
Stated Cetero: "The Untitled Letter (from the FDA) does not accept the results of our rigorous scientific analysis and discredits the company's 1,200 dedicated and experienced employees. The research conducted on behalf of our pharmaceutical sponsors can be, and has been, properly validated."
The FDA's statement slammed the company, saying that the agency had found a "pattern of misconduct" that raised questions about the accuracy of the data produced by Cetero. The FDA "concurred with Cetero's independent auditor, who stated: ‘This misconduct appears to be significant enough to cast doubt on the data generated...If the foundation of the laboratory is corrupt, then the data generated will be also.'"
- see the Cetero release