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FDA has sent a letter to Cetero Research informing the firm of “objectionable conditions” observed at its Houston bioanalytical facility during a May 2010 inspection. FDA alleges that company chemists falsified dates and times in laboratory records and manipulated equilibrium samples to meet predetermined acceptance criteria. The agency has concluded that data generated at the facility from April 2005 to June 2010, including data customers relied on for new drug applications, are unreliable. Cetero says it informed FDA of the problem after uncovering it two years ago and doesn’t understand why the agency sent the letter.
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