Cetero Research Houston lab accused of falsifying documentsThe founder of PRACS Institute in Fargo, which now is part of Cetero Research, said today he is uncertain what ramifications an FDA investigation into falsified documents at a Houston laboratory could have for its Fargo operations.
By: Patrick Springer, The Forum
FARGO – The founder of PRACS Institute in Fargo, which now is part of Cetero Research, said today he is uncertain what ramifications an FDA investigation into falsified documents at a Houston laboratory could have for its Fargo operations.
“I wish I had an answer for you,” James Carlson, said today, adding he was attending a board meeting at Cetero’s headquarters in Cary, N.C. “At the moment, I’m information gathering.”
The Food and Drug Administration has notified pharmaceutical companies that bioanalytical studies conducted by Cetero’s lab in Houston between April 2005 and June 2010 in support of marketing applications might have to be repeated or confirmed.
Two FDA inspections last year, an internal investigation and independent audit uncovered “significant instances of misconduct and violations” at the Texas lab.
In a statement, Cetero highlighted an FDA conclusion that, “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.”
Cetero said the problems first came in an internal investigation started more than two years ago, when the firm discovered six chemists in the Houston lab falsified dates on samples to get paid for weekend work and hours not actually worked.
Cetero said its processes are in “full compliance with FDA regulations and bioanalytical industry standards.”
Carlson founded PRACS Institute in Fargo in 1983. It was sold four or five years ago to Cetero. Last year, the company cut 23 jobs in Fargo when it closed its bioanalytical laboratory in a corporate reorganization.
Asked for his reaction to the irregularities that were uncovered in Houston, Carlson said he was “disappointed, but we’ve got a good team working on it. We’ve got top-flight people. We’ll make it through it.”
Cetero does early-phase clinical testing of drugs. Its Fargo operations at 4801 Amber Valley Parkway involve 544 beds and 14 study units.
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