The warning letter comes as Cetero’s checkered past continues to come to light. In June 2012 the company rebranded after data integrity issues dragged the company’s profits down. In March 2013 the rebranded company shut down, filed for bankruptcy and laid off all of its employees.
Failures
Gilbert Weiner was cited in the warning letter for failing to conduct hypersensitivity assessments, which the FDA says “jeopardizes subject safety and welfare, and compromises integrity of the data collected at your site.”
Weiner was also criticised for failing “to maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation.”
Records “were missing” on the listed subjects’ dosing periods, which indicated that hypersensitivity assessment forms were completed. Weiner’s response to the FDA was also deemed inadequate because he “did not provide an explanation for the missing study records,” and because he “did not provide a corrective action plan to prevent the recurrence of similar violations in the future.”
Cetero also sent an e-mail to the sponsor noting that due to the large number of subjects, Weiner signed and stamped blank forms “just prior to filling them out.”
“Please note, we expect that you will not pre-sign blank forms in FDA-regulated studies in the future,” investigators said.
The FDA concludes: “Your failure to maintain adequate and accurate case histories, including the failure to record signs and symptoms of hypersensitivity and the failure to maintain telemetry records and electrocardiograms, compromises the validity and integrity of data captured at your site and raises concern about the adequacy of your protection of study subjects enrolled at your site.”