By Allison Proffitt

July 29, 2011 | On Wednesday, one day after the FDA issued a letter accusing CRO Cetero of "significant violations" at a Cetero facility in Houston, the company responded in a letter on its website.

The FDA issued the July 27 letter (opens PDF) to Cetero because, "the pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during a 5 year time frame (April 1, 2005 to June 15, 2010)," said the FDA on its website, summarizing the situation.

Cetero says that it initiated its own internal investigation of the Houston facility over two years ago after noticing innacurate day/time data. The company says it reported its initial findings to FDA and sought agency feedback on its investigation plan.  The FDA, Cetero claims, did not respond to the initial report or any "monthly status reports" that Cetero filed voluntarily over the course of an 18-month investigation.

"The [FDA's] Untitled Letter 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," says Cetero in its media statement (opens PDF).

Cetero also points out that the FDA's did not question the safety or efficacy of drugs already approved or marketed. Indeed, the FDA's public announcement (though not the letter itself) states:  “It is unlikely that these concerns relating to data integrity affect the overall safety and efficacy of drugs already on the market and, at this time, there is no evidence of problems with the safety, quality, purity or potency of drugs already approved.”

The FDA's letter, however, does mention Cetero's internal investigation and acknowledges two reports of the internal investigation and one report of a third party investigation initiated by Cetero. According to FDA, the third party investigation along with two FDA investiations identified "deficiences with [the] internal investigation." The FDA also cites two 483 forms issued to Cetero in May 2010 and December 2010 proposing corrective action. "However... your 483 response letters do not adequately address the violations which FDA discovered during its inspections," the FDA continued.