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Cetero Research, a North Carolina-based early-stage contract research organization, faked documents and manipulated samples, according to three sources: two US Food and Drug administration inspections, an internal company investigation, and a third-party audit. As a result, the FDA has warned that drug companies who have used Cetero’s services may have to reevaluate their results, Reuters reports.
“The inspections and audit identified significant instances of misconduct and violations of federal regulations” at Cetero’s bioanalytical facility in Houston, Texas, the FDA said on Tuesday (July 26). "The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five-year time frame."
The investigations uncovered nearly 2,000 studies in which the overseeing lab technicians were not present at Cetero facilities ...