Executives at Cetero Research, a life sciences services firm based in Cary, are rebutting a broadside of criticism fired at the firm by the Food and Drug Administration on Wednesday.
The privately held company pointed out that it reported the problems to the FDA that the agency cited after conducting its own internal investigation. It also said all clients had been contacted about the situation.
In a letter to WRAL Tech Wire following a request for comment about the FDA letter and related documents that chastised Cetero for work done at the firm’s bioanayltical lab in Houston, Chief Executive Officer Troy McCall defended the firm and its integrity.
McCall wrote that the FDA action “discredits” the contract research organization’s 1,200 employees.
He also said that since Cetero had investigated the lab situation and had sought feedback from the FDA the regulatory agency’s actions were “even more difficult to understand.”
Read about the FDA report here.
The company’s “commitment to maintaining the quality and integrity” in data gathered for clinical trials “makes the broad action announced publicly by FDA … even more difficult to understand,” McCall said.
According to McCall, the company conducted an internal investigation “over two years ago” at the Houston lab when the firm discovered that a ‘small number of research chemists” recorded “inaccurate day/time data.” The details were forwarded to the FDA and clients were notified, McCall said.
“The Untitled Letter does not accept the results of our rigorous scientific analysis and discredits the Company’s 1,200 dedicated and experienced employees,” the CEO wrote. “The research conducted on behalf of our pharmaceutical sponsors can be, and has been, properly validated.”
McCall noted that the FDA acknowledged in its criticism of Cetero there “is no evidence of problems with the safety, quality, purity or potency of drugs already approved” based in part on Cetero lab work.
The company sought information from the FDA during an 18-month investigation that resulted from Cetero’s report but the agency “has not responded and remained silent to its content and all monthly status reports.”
Cetero responded to the FDA probe “in a timely fashion, with no response until the public announcement to the press and on its safety website … despite numerous follow up requests for resolution with the FDA.”
McCall said that following the FDA’s action this week “we will now have the opportunity for the first time since our voluntary disclosure was filed in June 2009 to meet with FDA decision-makers to seek to resolve this matter in an appropriate manner.”
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