Drugmakers that outsource their R&D, beware. The company collecting your preclinical data might be fudging its numbers.

According to a FDA letter published yesterday, Cetero Research, a North Carolina-based contract research organization (CRO), committed at least three violations over the past five years: employees falsified dates and times for lab work, technicians failed to properly calibrate their equipment for drug comparison assays, and the company kept poor records of their experiments.

The acts of misconduct “call into question the validity of all the information documented,” the FDA wrote. As a result, the agency is giving drug companies six months to repeat any assays included in FDA filings that were conducted by Cetero scientists. If drug companies fail to do so, the FDA will reevaluate the drug applications as if Cetero’s data were never submitted, the agency warned.

According to Kenneth Getz, senior research fellow at the Tufts Center for the Study of Drug Development in Boston, the notice signals that the FDA may be moving towards greater oversight of these third-party research companies. “When sponsors see that a CRO has received a warning like this from the FDA, it really has them all quite nervous,” he told Nature Medicine.

The FDA did not disclose which drugmakers employed Cetero, but each has received notice of the misconduct. Cetero Research has 15 days to submit a list of all FDA-related research performed between 1 April 2005 and 15 June 2010 when the violations occurred.